Colitis, Ulcerative
Conditions
Keywords
safety efficacy MultiStem(r) moderate to severe Ulcerative Colitis
Brief summary
MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells are believed to reduce inflammation and regulate immune system function, protect damaged or injured cells and tissue, promote formation of new blood vessels, and augment tissue repair and healing. MultiStem cell treatment resulted in significant efficacy in a mouse model of Graft versus Host Disease with almost complete reversal of gastrointestinal pathology (similar to pathology that would be expected in Ulcerative Colitis). These data, together with safety data generated in 2 other clinical trials, suggest that MultiStem has the potential to be a new treatment option for patients with ulcerative colitis. This is the first study of MultiStem in this patient population and will cautiously explore the safety/toleration and potential benefit of this new treatment in patients with moderate to severe disease.
Interventions
DRUGplacebo
once every 7 days for 1- 3 doses
DRUGMultiStem low dose
1-3 doses
DRUGMultiStem high dose
Single dose Day 1
Sponsors
Healios K.K.
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have a documented diagnosis of ulcerative colitis at least 6 months prior to screening. * Subjects must have active moderate-to-severe ulcerative colitis based on Mayo score. * Subjects must have Modified Baron endoscopic score of at least 2 determined within 7 days of first dosing. * Subjects must have failed or be intolerant (as determined by the investigator) of at least one of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine (6-MP), or anti-tumor necrosis factor (TNF) therapy, eg, infliximab or adalimumab. * Subjects must be on stable steroid doses.
Exclusion criteria
* Subjects who have abnormal organ and marrow function. * Subjects with a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease. * Subjects who meet Truelove-Witts criteria for severe ulcerative colitis. * Subjects receiving or who are expected to receive Infliximab or other biologic treatment within 8 weeks of the Day 1 study visit. * Subjects receiving or who are expected to receive Cyclosporine, mycophenolate, or tacrolimus within 4 weeks of the Day 1 study visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8 | Baseline and Week 8 | Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding). |
| Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4 | Baseline and Week 4 | Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease. |
| Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8 | Baseline and Week 8 | Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 52 | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. |
| Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | Baseline up to Week 52 | — |
| Number of Treatment-Emergent AEs by Severity | Baseline up to Week 52 | The intensity grades were defined as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Endoscopic Remission at Week 8 | Week 8 | Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding). Endoscopic remission is defined as modified Baron Endoscopic Score equal to 0. |
| Percentage of Participants in Clinical Remission at Week 8 | Week 8 | Clinical remission is defined as a total Mayo score of 2 points or lower, with no individual subscores exceeding 1 point. |
| Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12 and 16 | Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes). A decrease from baseline score indicates improvement. |
| Percentage of Participants With Endoscopic Response at Week 8 | Week 8 | Endoscopic response is defined as a decrease in modified Baron endoscopic score from baseline of at least 2 points. |
| Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Baseline, Week 12, Week 16 | Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease. |
| Change From Baseline in Total Mayo Scores at Week 8 | Baseline, Week 8 | Mayo Score is an instrument designed to measure disease activity of ulcerative colitis, with total score ranging from 0 to 12. It consists of 4 subscores (stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and physician global assessment \[PGA\]), each graded from 0 to 3, with higher scores indicating more severe disease. |
| Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12 and 16 | Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo Score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Higher scores indicate more severe disease. |
| Change From Baseline in Biopsy Histology Scores at Week 8 | Baseline and Week 8 | A 15 to 25 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease). |
| Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | Baseline and Week 16 | Patient-reported diary data assessed the number of bowel movements (BM) per day when not having a flare and the presence of blood in the stools (rectal bleeding \[RB\]), if any. |
| Percentage of Participants in Clinical Response at Week 8 | Week 8 | Clinical response is defined as a decrease in total Mayo score from baseline of at least 3 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1. |
| Number of Participants With Laboratory Test Abnormalities | Baseline up to Week 24 | The total number of participants with laboratory test abnormalities with or without regard to baseline abnormality was assessed. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte sedimentation rate); chemistry (blood urea nitrogen and creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase); other (follicle-stimulating hormone, human chorionic gonadotropin, stool microbiology, creatinine kinase, direct bilirubin, indirect bilirubin, gamma-glutamyl transferase, international normalized ratio. |
| Number of Participants With Potentially Clinically Significant Vital Signs Findings | Baseline up to Week 52 | Vital signs assessment included pulse rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP). Criteria for vital sign values meeting potential clinical concern included: SBP \<90 millimeters of mercury (mm Hg) and \>=30 mm Hg increase/decrease from baseline, DBP \<50 mm Hg and \>=20 mm Hg increase/decrease from baseline, pulse rate \<40 or \>120 beats per minute (bpm), |
| Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12 and 16 | Fecal calprotectin, a very stable marker, is a 36kDa calcium and zinc binding protein which is neutrophil-derived. It represents 60% of cytosolic proteins in granulocytes and is a measurement of neutrophil migration to the gastrointestinal tract. |
| Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12 and 16 | CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria. |
| Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 4, 8, 12 and 16 | Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes). |
Countries
Belgium, Canada, Germany, Hungary, Italy, Slovakia, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Placebo, MultiStem 300 Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8. | 2 |
| Cohort 2: Placebo, MultiStem 750 Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8. | 3 |
| Cohort 1: MultiStem 300 or MultiStem 300 (x3), Placebo Participants received either a single dose of MultiStem 300 Million Cells infusion on Day 1 or 3 doses on Day 1, Week 1, and Week 2; followed by a single dose of placebo infusion at Week 8. | 6 |
| Cohort 2: MultiStem 750, Placebo Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8. | 6 |
| Cohort 3: MultiStem 750, MultiStem 750 Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8. | 23 |
| Cohort 3: MultiStem 750, Placebo Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8. | 25 |
| Cohort 3: Placebo, MultiStem 750 Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8. | 19 |
| Cohort 3: Placebo, Placebo Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8. | 21 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 1 |
| Overall Study | Insufficient Clinical Response | 0 | 0 | 0 | 0 | 1 | 3 | 6 | 0 | 3 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 1 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 | 2 | 0 | 4 | 2 | 3 | 3 |
Baseline characteristics
| Characteristic | Cohort 1: Placebo, MultiStem 300 | Cohort 2: Placebo, MultiStem 750 | Cohort 1: MultiStem 300 or MultiStem 300 (x3), Placebo | Cohort 2: MultiStem 750, Placebo | Cohort 3: MultiStem 750, MultiStem 750 | Cohort 3: MultiStem 750, Placebo | Cohort 3: Placebo, MultiStem 750 | Cohort 3: Placebo, Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 61.0 years STANDARD_DEVIATION 7.1 | 52.0 years STANDARD_DEVIATION 7 | 49.3 years STANDARD_DEVIATION 14.1 | 40.0 years STANDARD_DEVIATION 14 | 43.4 years STANDARD_DEVIATION 12.8 | 38.8 years STANDARD_DEVIATION 13.4 | 39.8 years STANDARD_DEVIATION 12.5 | 42.5 years STANDARD_DEVIATION 15.7 | 42.2 years STANDARD_DEVIATION 13.7 |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants | 5 Participants | 7 Participants | 12 Participants | 3 Participants | 7 Participants | 36 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 5 Participants | 1 Participants | 16 Participants | 13 Participants | 16 Participants | 14 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 3 / 3 | 0 / 2 | 3 / 4 | 5 / 6 | 18 / 23 | 16 / 25 | 15 / 19 | 18 / 21 |
| serious Total, serious adverse events | 1 / 2 | 0 / 3 | 0 / 2 | 3 / 4 | 0 / 6 | 7 / 23 | 4 / 25 | 5 / 19 | 4 / 21 |
Outcome results
Primary
Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8
Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding).
Time frame: Baseline and Week 8
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint. Baseline observation carried forward (BOCF) was used for treatment failures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled MultiStem | Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8 | Baseline | 3.13 scores on a scale | Standard Deviation 1.104 |
| Pooled MultiStem | Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8 | Change at Week 8 | 0.10 scores on a scale | Standard Deviation 1.134 |
| Pooled Placebo | Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8 | Baseline | 3.10 scores on a scale | Standard Deviation 1.128 |
| Pooled Placebo | Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8 | Change at Week 8 | -0.30 scores on a scale | Standard Deviation 1.091 |
Comparison: Pooled MultiStem versus Pooled Placebop-value: 0.9680% CI: [0.12, 0.69]ANCOVA
Primary
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.
Time frame: Baseline and Week 4
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled MultiStem | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4 | Baseline | 1.42 scores on a scale | Standard Deviation 0.942 |
| Pooled MultiStem | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4 | Change at Week 4 | -0.44 scores on a scale | Standard Deviation 0.943 |
| Pooled Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4 | Baseline | 1.23 scores on a scale | Standard Deviation 0.832 |
| Pooled Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4 | Change at Week 4 | -0.38 scores on a scale | Standard Deviation 0.705 |
Comparison: Pooled MultiStem versus Pooled Placebo (Week 4)p-value: 0.5480% CI: [-0.19, 0.22]Mixed Models Analysis
Primary
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.
Time frame: Baseline and Week 8
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pooled MultiStem | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8 | -0.46 scores on a scale | Standard Deviation 1.051 |
| Pooled Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8 | -0.43 scores on a scale | Standard Deviation 0.874 |
Comparison: Pooled MultiStem versus Pooled Placebo (Week 8)p-value: 0.6780% CI: [-0.15, 0.3]Mixed Models Analysis
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Time frame: Baseline up to Week 52
Population: The safety analysis population consisted of all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled MultiStem | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 2 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 5 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 7 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 20 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 4 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 18 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 16 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 5 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 19 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 4 participants |
Primary
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC)
Time frame: Baseline up to Week 52
Population: The safety analysis population consisted of all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RENAL AND URINARY DISORDERS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | BLOOD AND LYMPHATIC SYSTEM DISORDERS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EYE DISORDERS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 1 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | ENDOCRINE DISORDERS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | METABOLISM AND NUTRITION DISORDERS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | CARDIAC DISORDERS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INFECTIONS AND INFESTATIONS | 1 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INVESTIGATIONS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | IMMUNE SYSTEM DISORDERS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NERVOUS SYSTEM DISORDERS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | VASCULAR DISORDERS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GENERAL DISORDERS | 2 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | PSYCHIATRIC DISORDERS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SURGICAL AND MEDICAL PROCEDURES | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EAR AND LABYRINTH DISORDERS | 0 participants |
| Pooled MultiStem | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GASTROINTESTINAL DISORDERS | 2 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EAR AND LABYRINTH DISORDERS | 0 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | METABOLISM AND NUTRITION DISORDERS | 0 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INVESTIGATIONS | 1 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | CARDIAC DISORDERS | 0 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | BLOOD AND LYMPHATIC SYSTEM DISORDERS | 0 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SURGICAL AND MEDICAL PROCEDURES | 0 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 0 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | ENDOCRINE DISORDERS | 0 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 1 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EYE DISORDERS | 0 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RENAL AND URINARY DISORDERS | 0 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GASTROINTESTINAL DISORDERS | 1 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | PSYCHIATRIC DISORDERS | 0 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GENERAL DISORDERS | 1 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NERVOUS SYSTEM DISORDERS | 1 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | IMMUNE SYSTEM DISORDERS | 0 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | VASCULAR DISORDERS | 0 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED | 0 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INFECTIONS AND INFESTATIONS | 1 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 2 participants |
| Pooled Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 1 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | CARDIAC DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | PSYCHIATRIC DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | IMMUNE SYSTEM DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INFECTIONS AND INFESTATIONS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SURGICAL AND MEDICAL PROCEDURES | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | ENDOCRINE DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RENAL AND URINARY DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GASTROINTESTINAL DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GENERAL DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INVESTIGATIONS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | VASCULAR DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | BLOOD AND LYMPHATIC SYSTEM DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EAR AND LABYRINTH DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EYE DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NERVOUS SYSTEM DISORDERS | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | METABOLISM AND NUTRITION DISORDERS | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EAR AND LABYRINTH DISORDERS | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | METABOLISM AND NUTRITION DISORDERS | 1 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GASTROINTESTINAL DISORDERS | 2 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | VASCULAR DISORDERS | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | PSYCHIATRIC DISORDERS | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SURGICAL AND MEDICAL PROCEDURES | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INFECTIONS AND INFESTATIONS | 1 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GENERAL DISORDERS | 3 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NERVOUS SYSTEM DISORDERS | 1 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | CARDIAC DISORDERS | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | IMMUNE SYSTEM DISORDERS | 1 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | ENDOCRINE DISORDERS | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | BLOOD AND LYMPHATIC SYSTEM DISORDERS | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 1 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 1 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INVESTIGATIONS | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EYE DISORDERS | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RENAL AND URINARY DISORDERS | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INVESTIGATIONS | 1 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | BLOOD AND LYMPHATIC SYSTEM DISORDERS | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | CARDIAC DISORDERS | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EAR AND LABYRINTH DISORDERS | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | ENDOCRINE DISORDERS | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EYE DISORDERS | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GASTROINTESTINAL DISORDERS | 4 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GENERAL DISORDERS | 1 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | IMMUNE SYSTEM DISORDERS | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INFECTIONS AND INFESTATIONS | 1 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | METABOLISM AND NUTRITION DISORDERS | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 2 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NERVOUS SYSTEM DISORDERS | 1 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | PSYCHIATRIC DISORDERS | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RENAL AND URINARY DISORDERS | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 1 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SURGICAL AND MEDICAL PROCEDURES | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | VASCULAR DISORDERS | 2 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | PSYCHIATRIC DISORDERS | 1 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | BLOOD AND LYMPHATIC SYSTEM DISORDERS | 5 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | METABOLISM AND NUTRITION DISORDERS | 2 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GENERAL DISORDERS | 8 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INFECTIONS AND INFESTATIONS | 10 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NERVOUS SYSTEM DISORDERS | 1 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | CARDIAC DISORDERS | 1 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GASTROINTESTINAL DISORDERS | 13 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 6 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 2 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 4 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EAR AND LABYRINTH DISORDERS | 1 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 5 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | VASCULAR DISORDERS | 1 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INVESTIGATIONS | 4 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | IMMUNE SYSTEM DISORDERS | 0 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | ENDOCRINE DISORDERS | 0 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED | 1 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SURGICAL AND MEDICAL PROCEDURES | 1 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RENAL AND URINARY DISORDERS | 1 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EYE DISORDERS | 1 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 4 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INFECTIONS AND INFESTATIONS | 9 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 5 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | IMMUNE SYSTEM DISORDERS | 2 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED | 0 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GENERAL DISORDERS | 5 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | BLOOD AND LYMPHATIC SYSTEM DISORDERS | 0 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NERVOUS SYSTEM DISORDERS | 3 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GASTROINTESTINAL DISORDERS | 10 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | PSYCHIATRIC DISORDERS | 1 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EYE DISORDERS | 0 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RENAL AND URINARY DISORDERS | 1 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | ENDOCRINE DISORDERS | 1 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 5 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EAR AND LABYRINTH DISORDERS | 0 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | VASCULAR DISORDERS | 1 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | METABOLISM AND NUTRITION DISORDERS | 0 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | CARDIAC DISORDERS | 0 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SURGICAL AND MEDICAL PROCEDURES | 0 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INVESTIGATIONS | 1 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 2 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GASTROINTESTINAL DISORDERS | 11 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED | 0 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RENAL AND URINARY DISORDERS | 0 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | ENDOCRINE DISORDERS | 1 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | BLOOD AND LYMPHATIC SYSTEM DISORDERS | 3 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | IMMUNE SYSTEM DISORDERS | 0 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INVESTIGATIONS | 5 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 1 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EAR AND LABYRINTH DISORDERS | 1 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 2 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 2 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 3 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | CARDIAC DISORDERS | 1 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | METABOLISM AND NUTRITION DISORDERS | 1 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | VASCULAR DISORDERS | 2 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INFECTIONS AND INFESTATIONS | 9 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NERVOUS SYSTEM DISORDERS | 9 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GENERAL DISORDERS | 5 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | PSYCHIATRIC DISORDERS | 3 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EYE DISORDERS | 0 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SURGICAL AND MEDICAL PROCEDURES | 1 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED | 0 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | VASCULAR DISORDERS | 1 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | METABOLISM AND NUTRITION DISORDERS | 1 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INFECTIONS AND INFESTATIONS | 7 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 2 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RENAL AND URINARY DISORDERS | 0 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | ENDOCRINE DISORDERS | 0 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | CARDIAC DISORDERS | 1 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | SURGICAL AND MEDICAL PROCEDURES | 0 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EYE DISORDERS | 3 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | PSYCHIATRIC DISORDERS | 2 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | IMMUNE SYSTEM DISORDERS | 0 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | BLOOD AND LYMPHATIC SYSTEM DISORDERS | 4 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GENERAL DISORDERS | 6 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 4 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | EAR AND LABYRINTH DISORDERS | 1 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | NERVOUS SYSTEM DISORDERS | 6 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INVESTIGATIONS | 3 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 1 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 1 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC) | GASTROINTESTINAL DISORDERS | 12 participants |
Primary
Number of Treatment-Emergent AEs by Severity
The intensity grades were defined as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function.
Time frame: Baseline up to Week 52
Population: The safety analysis population consisted of all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled MultiStem | Number of Treatment-Emergent AEs by Severity | Mild AEs | 6 adverse events |
| Pooled MultiStem | Number of Treatment-Emergent AEs by Severity | Severe AEs | 1 adverse events |
| Pooled MultiStem | Number of Treatment-Emergent AEs by Severity | Moderate AEs | 4 adverse events |
| Pooled Placebo | Number of Treatment-Emergent AEs by Severity | Moderate AEs | 0 adverse events |
| Pooled Placebo | Number of Treatment-Emergent AEs by Severity | Severe AEs | 0 adverse events |
| Pooled Placebo | Number of Treatment-Emergent AEs by Severity | Mild AEs | 16 adverse events |
| Cohort 1: MultiStem 300, Placebo | Number of Treatment-Emergent AEs by Severity | Moderate AEs | 0 adverse events |
| Cohort 1: MultiStem 300, Placebo | Number of Treatment-Emergent AEs by Severity | Mild AEs | 0 adverse events |
| Cohort 1: MultiStem 300, Placebo | Number of Treatment-Emergent AEs by Severity | Severe AEs | 0 adverse events |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Treatment-Emergent AEs by Severity | Severe AEs | 4 adverse events |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Treatment-Emergent AEs by Severity | Mild AEs | 8 adverse events |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Treatment-Emergent AEs by Severity | Moderate AEs | 5 adverse events |
| Cohort 2: MultiStem 750, Placebo | Number of Treatment-Emergent AEs by Severity | Mild AEs | 13 adverse events |
| Cohort 2: MultiStem 750, Placebo | Number of Treatment-Emergent AEs by Severity | Moderate AEs | 2 adverse events |
| Cohort 2: MultiStem 750, Placebo | Number of Treatment-Emergent AEs by Severity | Severe AEs | 0 adverse events |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Treatment-Emergent AEs by Severity | Severe AEs | 13 adverse events |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Treatment-Emergent AEs by Severity | Moderate AEs | 33 adverse events |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Treatment-Emergent AEs by Severity | Mild AEs | 61 adverse events |
| Cohort 3: MultiStem 750, Placebo | Number of Treatment-Emergent AEs by Severity | Severe AEs | 8 adverse events |
| Cohort 3: MultiStem 750, Placebo | Number of Treatment-Emergent AEs by Severity | Mild AEs | 35 adverse events |
| Cohort 3: MultiStem 750, Placebo | Number of Treatment-Emergent AEs by Severity | Moderate AEs | 31 adverse events |
| Cohort 3: Placebo, MultiStem 750 | Number of Treatment-Emergent AEs by Severity | Moderate AEs | 21 adverse events |
| Cohort 3: Placebo, MultiStem 750 | Number of Treatment-Emergent AEs by Severity | Mild AEs | 56 adverse events |
| Cohort 3: Placebo, MultiStem 750 | Number of Treatment-Emergent AEs by Severity | Severe AEs | 4 adverse events |
| Cohort 3: Placebo, Placebo | Number of Treatment-Emergent AEs by Severity | Moderate AEs | 17 adverse events |
| Cohort 3: Placebo, Placebo | Number of Treatment-Emergent AEs by Severity | Mild AEs | 48 adverse events |
| Cohort 3: Placebo, Placebo | Number of Treatment-Emergent AEs by Severity | Severe AEs | 3 adverse events |
Secondary
Change From Baseline in Biopsy Histology Scores at Week 8
A 15 to 25 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease).
Time frame: Baseline and Week 8
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled MultiStem | Change From Baseline in Biopsy Histology Scores at Week 8 | Baseline(n=2,3,2,4,5,22,24,18,21) | 9.0 scores on a scale | Standard Deviation 1.41 |
| Pooled MultiStem | Change From Baseline in Biopsy Histology Scores at Week 8 | Change at Week 4 (n=2,3,1,3,5,21,24,15,20) | -3.5 scores on a scale | Standard Deviation 4.95 |
| Pooled Placebo | Change From Baseline in Biopsy Histology Scores at Week 8 | Baseline(n=2,3,2,4,5,22,24,18,21) | 9.7 scores on a scale | Standard Deviation 3.79 |
| Pooled Placebo | Change From Baseline in Biopsy Histology Scores at Week 8 | Change at Week 4 (n=2,3,1,3,5,21,24,15,20) | 1.3 scores on a scale | Standard Deviation 1.15 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Biopsy Histology Scores at Week 8 | Baseline(n=2,3,2,4,5,22,24,18,21) | 11.0 scores on a scale | Standard Deviation 2.83 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Biopsy Histology Scores at Week 8 | Change at Week 4 (n=2,3,1,3,5,21,24,15,20) | -3.0 scores on a scale | — |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Biopsy Histology Scores at Week 8 | Baseline(n=2,3,2,4,5,22,24,18,21) | 7.0 scores on a scale | Standard Deviation 3.92 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Biopsy Histology Scores at Week 8 | Change at Week 4 (n=2,3,1,3,5,21,24,15,20) | -1.0 scores on a scale | Standard Deviation 1.73 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Biopsy Histology Scores at Week 8 | Baseline(n=2,3,2,4,5,22,24,18,21) | 10.8 scores on a scale | Standard Deviation 3.77 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Biopsy Histology Scores at Week 8 | Change at Week 4 (n=2,3,1,3,5,21,24,15,20) | -0.4 scores on a scale | Standard Deviation 2.07 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Biopsy Histology Scores at Week 8 | Change at Week 4 (n=2,3,1,3,5,21,24,15,20) | 1.4 scores on a scale | Standard Deviation 4.63 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Biopsy Histology Scores at Week 8 | Baseline(n=2,3,2,4,5,22,24,18,21) | 9.4 scores on a scale | Standard Deviation 4.37 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Biopsy Histology Scores at Week 8 | Change at Week 4 (n=2,3,1,3,5,21,24,15,20) | -1.0 scores on a scale | Standard Deviation 3.76 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Biopsy Histology Scores at Week 8 | Baseline(n=2,3,2,4,5,22,24,18,21) | 10.4 scores on a scale | Standard Deviation 4.24 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Biopsy Histology Scores at Week 8 | Baseline(n=2,3,2,4,5,22,24,18,21) | 9.9 scores on a scale | Standard Deviation 4.17 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Biopsy Histology Scores at Week 8 | Change at Week 4 (n=2,3,1,3,5,21,24,15,20) | 0.9 scores on a scale | Standard Deviation 4.09 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Biopsy Histology Scores at Week 8 | Baseline(n=2,3,2,4,5,22,24,18,21) | 9.7 scores on a scale | Standard Deviation 5.14 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Biopsy Histology Scores at Week 8 | Change at Week 4 (n=2,3,1,3,5,21,24,15,20) | -1.5 scores on a scale | Standard Deviation 4.8 |
Comparison: Pooled MultiStem versus Pooled Placebop-value: 0.7580% CI: [-0.46, 1.49]ANCOVA
Secondary
Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo Score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Higher scores indicate more severe disease.
Time frame: Baseline, Weeks 4, 8, 12 and 16
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled MultiStem | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,5,23,25,19,21) | -3.00 scores on a scale | Standard Deviation 0 |
| Pooled MultiStem | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 16 (2,3,2,4,5,21,24,17,19) | -1.50 scores on a scale | Standard Deviation 0.707 |
| Pooled MultiStem | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,23,25,19,21) | 7.50 scores on a scale | Standard Deviation 2.121 |
| Pooled MultiStem | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | NA scores on a scale | — |
| Pooled MultiStem | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | -2.00 scores on a scale | Standard Deviation 1.414 |
| Pooled Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | -1.00 scores on a scale | Standard Deviation 1.732 |
| Pooled Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,23,25,19,21) | 5.33 scores on a scale | Standard Deviation 0.577 |
| Pooled Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 16 (2,3,2,4,5,21,24,17,19) | -3.00 scores on a scale | Standard Deviation 3 |
| Pooled Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,5,23,25,19,21) | -2.00 scores on a scale | Standard Deviation 1.732 |
| Pooled Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | NA scores on a scale | — |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | NA scores on a scale | — |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | 0.50 scores on a scale | Standard Deviation 0.707 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,23,25,19,21) | 6.00 scores on a scale | Standard Deviation 1.414 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 16 (2,3,2,4,5,21,24,17,19) | -1.00 scores on a scale | Standard Deviation 2.828 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,5,23,25,19,21) | -0.50 scores on a scale | Standard Deviation 0.707 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 16 (2,3,2,4,5,21,24,17,19) | -1.25 scores on a scale | Standard Deviation 3.403 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,5,23,25,19,21) | 0.67 scores on a scale | Standard Deviation 1.528 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | NA scores on a scale | — |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,23,25,19,21) | 5.75 scores on a scale | Standard Deviation 0.5 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | 0.33 scores on a scale | Standard Deviation 0.577 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | -0.80 scores on a scale | Standard Deviation 1.095 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,23,25,19,21) | 5.50 scores on a scale | Standard Deviation 1.378 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,5,23,25,19,21) | -0.40 scores on a scale | Standard Deviation 1.14 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | NA scores on a scale | — |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 16 (2,3,2,4,5,21,24,17,19) | -2.20 scores on a scale | Standard Deviation 1.924 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,5,23,25,19,21) | -1.00 scores on a scale | Standard Deviation 1.414 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | -0.91 scores on a scale | Standard Deviation 1.756 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | -1.91 scores on a scale | Standard Deviation 1.974 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 16 (2,3,2,4,5,21,24,17,19) | -1.86 scores on a scale | Standard Deviation 2.081 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,23,25,19,21) | 6.22 scores on a scale | Standard Deviation 1.347 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | -1.12 scores on a scale | Standard Deviation 2.472 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,5,23,25,19,21) | -0.96 scores on a scale | Standard Deviation 1.791 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,23,25,19,21) | 6.08 scores on a scale | Standard Deviation 1.605 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | -1.52 scores on a scale | Standard Deviation 2.312 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 16 (2,3,2,4,5,21,24,17,19) | -2.54 scores on a scale | Standard Deviation 2.621 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | -0.79 scores on a scale | Standard Deviation 1.653 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,5,23,25,19,21) | -1.16 scores on a scale | Standard Deviation 1.675 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 16 (2,3,2,4,5,21,24,17,19) | -2.41 scores on a scale | Standard Deviation 2.181 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | -2.06 scores on a scale | Standard Deviation 2.135 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,23,25,19,21) | 6.00 scores on a scale | Standard Deviation 1.202 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 16 (2,3,2,4,5,21,24,17,19) | -2.63 scores on a scale | Standard Deviation 2.033 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,23,25,19,21) | 5.71 scores on a scale | Standard Deviation 1.736 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | -2.11 scores on a scale | Standard Deviation 2.622 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,5,23,25,19,21) | -1.24 scores on a scale | Standard Deviation 1.895 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | -1.62 scores on a scale | Standard Deviation 2.037 |
Comparison: Cohort 3 PM versus Cohort 3 PP (Week 12)p-value: 0.7280% CI: [-0.5, 1.33]Mixed Models Analysis
Comparison: Cohort 3 MM versus Cohort 3 PP (Week 16)p-value: 0.9780% CI: [0.37, 2.06]Mixed Models Analysis
Comparison: Pooled MultiStem versus Pooled Placebo (Week 4)p-value: 0.880% CI: [-0.15, 0.74]Mixed Models Analysis
Comparison: Pooled MultiStem versus Pooled Placebo (Week 8)p-value: 0.7780% CI: [-0.23, 0.84]Mixed Models Analysis
Comparison: Cohort 3 MM versus Cohort 3 PP (Week 12)p-value: 0.7480% CI: [-0.42, 1.3]Mixed Models Analysis
Comparison: Cohort 3 MP versus Cohort 3 PP (Week 12)p-value: 0.8880% CI: [-0.08, 1.59]Mixed Models Analysis
Comparison: Cohort 3 MP versus Cohort 3 PP (Week 16)p-value: 0.7580% CI: [-0.39, 1.25]Mixed Models Analysis
Comparison: Cohort 3 PM versus Cohort 3 PP (Week 16)p-value: 0.8580% CI: [-0.16, 1.63]Mixed Models Analysis
Secondary
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16
Patient-reported diary data assessed the number of bowel movements (BM) per day when not having a flare and the presence of blood in the stools (rectal bleeding \[RB\]), if any.
Time frame: Baseline and Week 16
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled MultiStem | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | 0.14 scores on a scale | — |
| Pooled MultiStem | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 8 (n=2,3,2,3,6,22,23,13,20) | -0.75 scores on a scale | Standard Deviation 0.354 |
| Pooled MultiStem | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 4 (n=2,2,2,3,5,23,23,16,19) | -0.75 scores on a scale | Standard Deviation 0.354 |
| Pooled MultiStem | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 8 (n=2,3,2,3,6,23,23,16,19) | -1.67 scores on a scale | Standard Deviation 3.771 |
| Pooled MultiStem | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Baseline(n=2,3,2,4,6,23,25,19,21) | 12.50 scores on a scale | Standard Deviation 4.95 |
| Pooled MultiStem | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -1.00 scores on a scale | — |
| Pooled MultiStem | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -1.60 scores on a scale | Standard Deviation 2.263 |
| Pooled MultiStem | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -0.32 scores on a scale | Standard Deviation 0.253 |
| Pooled MultiStem | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | -0.57 scores on a scale | — |
| Pooled MultiStem | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 4 (n=2,2,2,3,5,23,23,16,19 | -1.43 scores on a scale | Standard Deviation 3.435 |
| Pooled MultiStem | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Baseline (n=2,3,2,4,6,23,25,19,21) | 1.25 scores on a scale | Standard Deviation 1.061 |
| Pooled MultiStem | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | 0.00 scores on a scale | — |
| Pooled Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -2.51 scores on a scale | Standard Deviation 3.716 |
| Pooled Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 8 (n=2,3,2,3,6,22,23,13,20) | -0.50 scores on a scale | Standard Deviation 0.5 |
| Pooled Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | 1.43 scores on a scale | — |
| Pooled Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Baseline(n=2,3,2,4,6,23,25,19,21) | 8.00 scores on a scale | Standard Deviation 2.784 |
| Pooled Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -1.00 scores on a scale | Standard Deviation 1.167 |
| Pooled Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 8 (n=2,3,2,3,6,23,23,16,19) | -0.86 scores on a scale | Standard Deviation 3.517 |
| Pooled Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Baseline (n=2,3,2,4,6,23,25,19,21) | 1.17 scores on a scale | Standard Deviation 1.258 |
| Pooled Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 4 (n=2,2,2,3,5,23,23,16,19) | -0.29 scores on a scale | Standard Deviation 1.01 |
| Pooled Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -1.17 scores on a scale | Standard Deviation 1.258 |
| Pooled Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | 0.00 scores on a scale | — |
| Pooled Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 4 (n=2,2,2,3,5,23,23,16,19 | -1.89 scores on a scale | Standard Deviation 5.101 |
| Pooled Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -1.89 scores on a scale | Standard Deviation 1.766 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 8 (n=2,3,2,3,6,23,23,16,19) | 3.18 scores on a scale | Standard Deviation 0.758 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Baseline (n=2,3,2,4,6,23,25,19,21) | 1.00 scores on a scale | Standard Deviation 1.414 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -0.10 scores on a scale | Standard Deviation 0.141 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | 4.15 scores on a scale | Standard Deviation 2.845 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | 0.00 scores on a scale | — |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 4 (n=2,2,2,3,5,23,23,16,19 | 2.36 scores on a scale | Standard Deviation 0.505 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Baseline(n=2,3,2,4,6,23,25,19,21) | 6.75 scores on a scale | Standard Deviation 2.475 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | 1.72 scores on a scale | Standard Deviation 0.596 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 4 (n=2,2,2,3,5,23,23,16,19) | -0.25 scores on a scale | Standard Deviation 0.354 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | 1.57 scores on a scale | — |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 8 (n=2,3,2,3,6,22,23,13,20) | 0.00 scores on a scale | Standard Deviation 0 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -0.33 scores on a scale | Standard Deviation 0.471 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -0.12 scores on a scale | Standard Deviation 0.158 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 8 (n=2,3,2,3,6,22,23,13,20) | 0.33 scores on a scale | Standard Deviation 0.577 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 4 (n=2,2,2,3,5,23,23,16,19 | 0.17 scores on a scale | Standard Deviation 2.038 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Baseline (n=2,3,2,4,6,23,25,19,21) | 1.00 scores on a scale | Standard Deviation 0.816 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | -1.68 scores on a scale | Standard Deviation 2.374 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | 0.33 scores on a scale | Standard Deviation 0.577 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -0.12 scores on a scale | Standard Deviation 2.324 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | 0.00 scores on a scale | Standard Deviation 0 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Baseline(n=2,3,2,4,6,23,25,19,21) | 11.75 scores on a scale | Standard Deviation 10.508 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -0.60 scores on a scale | Standard Deviation 2.177 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 8 (n=2,3,2,3,6,23,23,16,19) | 0.17 scores on a scale | Standard Deviation 2.754 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 4 (n=2,2,2,3,5,23,23,16,19) | 0.14 scores on a scale | Standard Deviation 0.378 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | 0.00 scores on a scale | Standard Deviation 0 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Baseline(n=2,3,2,4,6,23,25,19,21) | 8.42 scores on a scale | Standard Deviation 3.089 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | 0.40 scores on a scale | Standard Deviation 1.3 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 4 (n=2,2,2,3,5,23,23,16,19 | 1.31 scores on a scale | Standard Deviation 1.432 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 8 (n=2,3,2,3,6,23,23,16,19) | 0.41 scores on a scale | Standard Deviation 2.131 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -2.45 scores on a scale | Standard Deviation 2.208 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Baseline (n=2,3,2,4,6,23,25,19,21) | 1.33 scores on a scale | Standard Deviation 0.816 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -0.30 scores on a scale | Standard Deviation 0.415 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 4 (n=2,2,2,3,5,23,23,16,19) | -0.71 scores on a scale | Standard Deviation 0.99 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 8 (n=2,3,2,3,6,22,23,13,20) | -0.47 scores on a scale | Standard Deviation 1.035 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | 0.00 scores on a scale | Standard Deviation 0 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -1.14 scores on a scale | Standard Deviation 0.865 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | -0.60 scores on a scale | Standard Deviation 0.792 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | -0.67 scores on a scale | Standard Deviation 3.152 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -0.36 scores on a scale | Standard Deviation 0.697 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 8 (n=2,3,2,3,6,23,23,16,19) | -0.89 scores on a scale | Standard Deviation 2.864 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -0.41 scores on a scale | Standard Deviation 0.936 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 4 (n=2,2,2,3,5,23,23,16,19) | -0.34 scores on a scale | Standard Deviation 0.883 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 4 (n=2,2,2,3,5,23,23,16,19 | -0.81 scores on a scale | Standard Deviation 2.088 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 8 (n=2,3,2,3,6,22,23,13,20) | -0.40 scores on a scale | Standard Deviation 0.709 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -0.42 scores on a scale | Standard Deviation 1.509 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Baseline (n=2,3,2,4,6,23,25,19,21) | 1.20 scores on a scale | Standard Deviation 0.974 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -1.81 scores on a scale | Standard Deviation 3.278 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Baseline(n=2,3,2,4,6,23,25,19,21) | 7.50 scores on a scale | Standard Deviation 3.49 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 4 (n=2,2,2,3,5,23,23,16,19) | -0.47 scores on a scale | Standard Deviation 0.84 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Baseline (n=2,3,2,4,6,23,25,19,21) | 1.46 scores on a scale | Standard Deviation 0.978 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | -0.59 scores on a scale | Standard Deviation 4.426 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 4 (n=2,2,2,3,5,23,23,16,19 | 0.28 scores on a scale | Standard Deviation 3.956 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -0.24 scores on a scale | Standard Deviation 0.605 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 8 (n=2,3,2,3,6,23,23,16,19) | -1.15 scores on a scale | Standard Deviation 2.833 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -0.86 scores on a scale | Standard Deviation 1.106 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 8 (n=2,3,2,3,6,22,23,13,20) | -0.51 scores on a scale | Standard Deviation 0.805 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Baseline(n=2,3,2,4,6,23,25,19,21) | 7.78 scores on a scale | Standard Deviation 3.781 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -0.59 scores on a scale | Standard Deviation 1.657 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -2.17 scores on a scale | Standard Deviation 3.523 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | -0.49 scores on a scale | Standard Deviation 1.084 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Baseline(n=2,3,2,4,6,23,25,19,21) | 7.50 scores on a scale | Standard Deviation 3.571 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -0.41 scores on a scale | Standard Deviation 0.838 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Baseline (n=2,3,2,4,6,23,25,19,21) | 0.97 scores on a scale | Standard Deviation 0.95 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 4 (n=2,2,2,3,5,23,23,16,19) | -0.27 scores on a scale | Standard Deviation 0.738 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | -1.77 scores on a scale | Standard Deviation 2.301 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -1.68 scores on a scale | Standard Deviation 2.899 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | -0.48 scores on a scale | Standard Deviation 0.829 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 8 (n=2,3,2,3,6,23,23,16,19) | 0.18 scores on a scale | Standard Deviation 2.531 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 4 (n=2,2,2,3,5,23,23,16,19 | -0.63 scores on a scale | Standard Deviation 1.856 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -0.56 scores on a scale | Standard Deviation 1.215 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 8 (n=2,3,2,3,6,22,23,13,20) | -0.19 scores on a scale | Standard Deviation 0.997 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -0.05 scores on a scale | Standard Deviation 0.574 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -0.81 scores on a scale | Standard Deviation 3.421 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Baseline(n=2,3,2,4,6,23,25,19,21) | 6.88 scores on a scale | Standard Deviation 4.886 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 4 (n=2,2,2,3,5,23,23,16,19 | -1.08 scores on a scale | Standard Deviation 2.575 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 4 (n=2,2,2,3,5,23,23,16,19) | -0.26 scores on a scale | Standard Deviation 0.604 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -1.86 scores on a scale | Standard Deviation 3.616 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 8 (n=2,3,2,3,6,22,23,13,20) | -0.51 scores on a scale | Standard Deviation 0.967 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 1 (n=2,3,2,4,5,23,25,19,21) | -0.10 scores on a scale | Standard Deviation 0.408 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | -2.02 scores on a scale | Standard Deviation 3.502 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Baseline (n=2,3,2,4,6,23,25,19,21) | 1.05 scores on a scale | Standard Deviation 0.82 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | BM: Change at Week 8 (n=2,3,2,3,6,23,23,16,19) | -1.41 scores on a scale | Standard Deviation 3.208 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 16 (n=1,3,2,3,4,22,24,16,18) | -0.39 scores on a scale | Standard Deviation 0.874 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16 | RB: Change at Week 12 (n=1,1,1,2,2,21,25,16,18) | -0.39 scores on a scale | Standard Deviation 0.783 |
Comparison: Pooled MultiStem versus Pooled Placebo (Week 4)p-value: 0.5180% CI: [-0.18, 0.19]Mixed Models Analysis
Comparison: Pooled MultiStem versus Pooled Placebo (Week 8)p-value: 0.6280% CI: [-0.16, 0.25]Mixed Models Analysis
Comparison: Cohort 3 MM versus Cohort 3 PP (Week 12)p-value: 0.2980% CI: [-0.39, 0.16]Mixed Models Analysis
Comparison: Cohort 3 MP versus Cohort 3 PP (Week 12)p-value: 0.7480% CI: [-0.14, 0.4]Mixed Models Analysis
Comparison: Cohort 3 PM versus Cohort 3 PP (Week 12)p-value: 0.3680% CI: [-0.37, 0.21]Mixed Models Analysis
Comparison: Cohort 3 MM versus Cohort 3 PP (Week 16)p-value: 0.5680% CI: [-0.26, 0.34]Mixed Models Analysis
Comparison: Cohort 3 MP versus Cohort 3 PP (Week 16)p-value: 0.1880% CI: [-0.51, 0.09]Mixed Models Analysis
Comparison: Cohort 3 PM versus Cohort 3 PP (Week 16)p-value: 0.3180% CI: [-0.45, 0.2]Mixed Models Analysis
Secondary
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.
Time frame: Baseline, Week 12, Week 16
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled MultiStem | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | NA scores on a scale | — |
| Pooled MultiStem | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 16 (n=2,3,2,4,6,21,24,17,19) | -1.50 scores on a scale | Standard Deviation 0.707 |
| Pooled Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 16 (n=2,3,2,4,6,21,24,17,19) | -1.00 scores on a scale | Standard Deviation 1 |
| Pooled Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | NA scores on a scale | — |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 16 (n=2,3,2,4,6,21,24,17,19) | 0.00 scores on a scale | Standard Deviation 0 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | NA scores on a scale | — |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | NA scores on a scale | — |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 16 (n=2,3,2,4,6,21,24,17,19) | 0.00 scores on a scale | Standard Deviation 0.816 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | NA scores on a scale | — |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 16 (n=2,3,2,4,6,21,24,17,19) | -0.60 scores on a scale | Standard Deviation 1.14 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 16 (n=2,3,2,4,6,21,24,17,19) | -0.57 scores on a scale | Standard Deviation 0.978 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | -0.77 scores on a scale | Standard Deviation 0.869 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | -0.64 scores on a scale | Standard Deviation 1.114 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 16 (n=2,3,2,4,6,21,24,17,19) | -0.92 scores on a scale | Standard Deviation 1.1 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | -0.53 scores on a scale | Standard Deviation 0.874 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 16 (n=2,3,2,4,6,21,24,17,19) | -0.47 scores on a scale | Standard Deviation 0.874 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 12 (n=0,0,0,0,0,22,25,17,19) | -0.47 scores on a scale | Standard Deviation 0.905 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16 | Change at Week 16 (n=2,3,2,4,6,21,24,17,19) | -0.58 scores on a scale | Standard Deviation 0.838 |
Secondary
Change From Baseline in Total Mayo Scores at Week 8
Mayo Score is an instrument designed to measure disease activity of ulcerative colitis, with total score ranging from 0 to 12. It consists of 4 subscores (stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and physician global assessment \[PGA\]), each graded from 0 to 3, with higher scores indicating more severe disease.
Time frame: Baseline, Week 8
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled MultiStem | Change From Baseline in Total Mayo Scores at Week 8 | Baseline (n=2,3,2,4,6,23,25,19,21) | 10.00 scores on a scale | Standard Deviation 2.828 |
| Pooled MultiStem | Change From Baseline in Total Mayo Scores at Week 8 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | -2.00 scores on a scale | Standard Deviation 1.414 |
| Pooled Placebo | Change From Baseline in Total Mayo Scores at Week 8 | Baseline (n=2,3,2,4,6,23,25,19,21) | 7.33 scores on a scale | Standard Deviation 1.155 |
| Pooled Placebo | Change From Baseline in Total Mayo Scores at Week 8 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | 0.00 scores on a scale | Standard Deviation 2.646 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Total Mayo Scores at Week 8 | Baseline (n=2,3,2,4,6,23,25,19,21) | 8.50 scores on a scale | Standard Deviation 0.707 |
| Cohort 1: MultiStem 300, Placebo | Change From Baseline in Total Mayo Scores at Week 8 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | 1.00 scores on a scale | Standard Deviation 1.414 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Total Mayo Scores at Week 8 | Baseline (n=2,3,2,4,6,23,25,19,21) | 7.75 scores on a scale | Standard Deviation 0.957 |
| Cohort 1: MultiStem 300 (x3), Placebo | Change From Baseline in Total Mayo Scores at Week 8 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | 0.33 scores on a scale | Standard Deviation 0.577 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Total Mayo Scores at Week 8 | Baseline (n=2,3,2,4,6,23,25,19,21) | 7.50 scores on a scale | Standard Deviation 2.258 |
| Cohort 2: MultiStem 750, Placebo | Change From Baseline in Total Mayo Scores at Week 8 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | -0.60 scores on a scale | Standard Deviation 0.894 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Total Mayo Scores at Week 8 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | -0.78 scores on a scale | Standard Deviation 2.088 |
| Cohort 3: MultiStem 750, MultiStem 750 | Change From Baseline in Total Mayo Scores at Week 8 | Baseline (n=2,3,2,4,6,23,25,19,21) | 8.74 scores on a scale | Standard Deviation 1.839 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Total Mayo Scores at Week 8 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | -1.20 scores on a scale | Standard Deviation 2.872 |
| Cohort 3: MultiStem 750, Placebo | Change From Baseline in Total Mayo Scores at Week 8 | Baseline (n=2,3,2,4,6,23,25,19,21) | 8.48 scores on a scale | Standard Deviation 2.143 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Total Mayo Scores at Week 8 | Baseline (n=2,3,2,4,6,23,25,19,21) | 8.47 scores on a scale | Standard Deviation 1.806 |
| Cohort 3: Placebo, MultiStem 750 | Change From Baseline in Total Mayo Scores at Week 8 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | -0.89 scores on a scale | Standard Deviation 2.132 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Total Mayo Scores at Week 8 | Baseline (n=2,3,2,4,6,23,25,19,21) | 8.14 scores on a scale | Standard Deviation 2.22 |
| Cohort 3: Placebo, Placebo | Change From Baseline in Total Mayo Scores at Week 8 | Change at Week 8 (n=2,3,2,3,5,23,25,19,21) | -2.00 scores on a scale | Standard Deviation 2.683 |
Comparison: Pooled MultiStem versus Pooled Placebop-value: 0.8780% CI: [-0.08, 1.24]ANCOVA
Secondary
Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16
CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria.
Time frame: Baseline, Weeks 4, 8, 12 and 16
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled MultiStem | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,6,21,25,18,20) | 0.289 fold change | Geometric Coefficient of Variation 9 |
| Pooled MultiStem | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,2,4,5,20,24,17,18) | 0.956 fold change | Geometric Coefficient of Variation 164 |
| Pooled MultiStem | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,22,25,19,20) | 1.272 fold change | Geometric Coefficient of Variation 45 |
| Pooled MultiStem | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,21,24,17,18) | NA fold change | — |
| Pooled MultiStem | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,3,1,3,5,21,25,19,20) | 1.390 fold change | — |
| Pooled Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,3,1,3,5,21,25,19,20) | 0.745 fold change | Geometric Coefficient of Variation 49 |
| Pooled Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,22,25,19,20) | 1.527 fold change | Geometric Coefficient of Variation 118 |
| Pooled Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,2,4,5,20,24,17,18) | 0.481 fold change | Geometric Coefficient of Variation 56 |
| Pooled Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,6,21,25,18,20) | 0.555 fold change | Geometric Coefficient of Variation 82 |
| Pooled Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,21,24,17,18) | NA fold change | — |
| Cohort 1: MultiStem 300, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,21,24,17,18) | NA fold change | — |
| Cohort 1: MultiStem 300, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,3,1,3,5,21,25,19,20) | 2.331 fold change | — |
| Cohort 1: MultiStem 300, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,22,25,19,20) | 0.229 fold change | Geometric Coefficient of Variation 34 |
| Cohort 1: MultiStem 300, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,2,4,5,20,24,17,18) | 0.606 fold change | Geometric Coefficient of Variation 248 |
| Cohort 1: MultiStem 300, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,6,21,25,18,20) | 1.937 fold change | Geometric Coefficient of Variation 42 |
| Cohort 1: MultiStem 300 (x3), Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,2,4,5,20,24,17,18) | 0.869 fold change | Geometric Coefficient of Variation 14 |
| Cohort 1: MultiStem 300 (x3), Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,6,21,25,18,20) | 1.285 fold change | Geometric Coefficient of Variation 60 |
| Cohort 1: MultiStem 300 (x3), Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,21,24,17,18) | NA fold change | — |
| Cohort 1: MultiStem 300 (x3), Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,22,25,19,20) | 0.578 fold change | Geometric Coefficient of Variation 37 |
| Cohort 1: MultiStem 300 (x3), Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,3,1,3,5,21,25,19,20) | 1.172 fold change | Geometric Coefficient of Variation 20 |
| Cohort 2: MultiStem 750, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,3,1,3,5,21,25,19,20) | 1.555 fold change | Geometric Coefficient of Variation 31 |
| Cohort 2: MultiStem 750, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,22,25,19,20) | 0.180 fold change | Geometric Coefficient of Variation 74 |
| Cohort 2: MultiStem 750, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,6,21,25,18,20) | 1.446 fold change | Geometric Coefficient of Variation 54 |
| Cohort 2: MultiStem 750, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,21,24,17,18) | NA fold change | — |
| Cohort 2: MultiStem 750, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,2,4,5,20,24,17,18) | 1.184 fold change | Geometric Coefficient of Variation 54 |
| Cohort 3: MultiStem 750, MultiStem 750 | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,6,21,25,18,20) | 0.891 fold change | Geometric Coefficient of Variation 147 |
| Cohort 3: MultiStem 750, MultiStem 750 | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,3,1,3,5,21,25,19,20) | 1.189 fold change | Geometric Coefficient of Variation 146 |
| Cohort 3: MultiStem 750, MultiStem 750 | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,21,24,17,18) | 0.937 fold change | Geometric Coefficient of Variation 211 |
| Cohort 3: MultiStem 750, MultiStem 750 | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,2,4,5,20,24,17,18) | 0.776 fold change | Geometric Coefficient of Variation 156 |
| Cohort 3: MultiStem 750, MultiStem 750 | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,22,25,19,20) | 0.613 fold change | Geometric Coefficient of Variation 339 |
| Cohort 3: MultiStem 750, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,3,1,3,5,21,25,19,20) | 0.759 fold change | Geometric Coefficient of Variation 207 |
| Cohort 3: MultiStem 750, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,6,21,25,18,20) | 0.764 fold change | Geometric Coefficient of Variation 140 |
| Cohort 3: MultiStem 750, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,22,25,19,20) | 0.542 fold change | Geometric Coefficient of Variation 236 |
| Cohort 3: MultiStem 750, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,21,24,17,18) | 0.710 fold change | Geometric Coefficient of Variation 365 |
| Cohort 3: MultiStem 750, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,2,4,5,20,24,17,18) | 0.425 fold change | Geometric Coefficient of Variation 176 |
| Cohort 3: Placebo, MultiStem 750 | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,3,1,3,5,21,25,19,20) | 1.200 fold change | Geometric Coefficient of Variation 113 |
| Cohort 3: Placebo, MultiStem 750 | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,6,21,25,18,20) | 0.999 fold change | Geometric Coefficient of Variation 103 |
| Cohort 3: Placebo, MultiStem 750 | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,2,4,5,20,24,17,18) | 0.612 fold change | Geometric Coefficient of Variation 133 |
| Cohort 3: Placebo, MultiStem 750 | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,21,24,17,18) | 0.782 fold change | Geometric Coefficient of Variation 149 |
| Cohort 3: Placebo, MultiStem 750 | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,22,25,19,20) | 0.397 fold change | Geometric Coefficient of Variation 157 |
| Cohort 3: Placebo, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,2,4,5,20,24,17,18) | 0.417 fold change | Geometric Coefficient of Variation 197 |
| Cohort 3: Placebo, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,2,4,6,22,25,19,20) | 0.453 fold change | Geometric Coefficient of Variation 297 |
| Cohort 3: Placebo, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,21,24,17,18) | 0.373 fold change | Geometric Coefficient of Variation 155 |
| Cohort 3: Placebo, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,2,3,6,21,25,18,20) | 0.588 fold change | Geometric Coefficient of Variation 132 |
| Cohort 3: Placebo, Placebo | Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,3,1,3,5,21,25,19,20) | 0.623 fold change | Geometric Coefficient of Variation 150 |
Comparison: Pooled MultiStem versus Pooled Placebo (Week 4)p-value: 0.7980% CI: [0.91, 1.51]Mixed Models Analysis
Comparison: Pooled MultiStem versus Pooled Placebo (Week 8)p-value: 0.880% CI: [0.9, 1.63]Mixed Models Analysis
Comparison: Cohort 3 MM versus Cohort 3 PP (Week 12)p-value: 0.9980% CI: [1.63, 4.64]Mixed Models Analysis
Comparison: Cohort 3 MP versus Cohort 3 PP (Week 12)p-value: 0.9680% CI: [1.19, 3.25]Mixed Models Analysis
Comparison: Cohort 3 PM versus Cohort 3 PP (Week 12)p-value: 0.9580% CI: [1.15, 3.41]Mixed Models Analysis
Comparison: Cohort 3 MM versus Cohort 3 PP (Week 16)p-value: 0.9980% CI: [1.52, 3.48]Mixed Models Analysis
Comparison: Cohort 3 MP versus Cohort 3 PP (Week 16)p-value: 0.6280% CI: [0.74, 1.63]Mixed Models Analysis
Comparison: Cohort 3 PM versus Cohort 3 PP (Week 16)p-value: 0.8980% CI: [0.98, 2.32]Mixed Models Analysis
Secondary
Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16
Fecal calprotectin, a very stable marker, is a 36kDa calcium and zinc binding protein which is neutrophil-derived. It represents 60% of cytosolic proteins in granulocytes and is a measurement of neutrophil migration to the gastrointestinal tract.
Time frame: Baseline, Weeks 4, 8, 12 and 16
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled MultiStem | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,1,3,5,20,21,18,19) | 0.6297 fold change | Geometric Coefficient of Variation 50 |
| Pooled MultiStem | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,1,4,4,18,18,16,17) | 2.1672 fold change | Geometric Coefficient of Variation 49 |
| Pooled MultiStem | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,1,4,5,21,23,19,20) | 690.7549 fold change | Geometric Coefficient of Variation 17 |
| Pooled MultiStem | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,20,21,17,18) | NA fold change | — |
| Pooled MultiStem | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,2,1,3,2,18,20,17,20) | 2.4504 fold change | — |
| Pooled Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,2,1,3,2,18,20,17,20) | 2.4559 fold change | Geometric Coefficient of Variation 51 |
| Pooled Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,1,4,5,21,23,19,20) | 1189.8169 fold change | Geometric Coefficient of Variation 22 |
| Pooled Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,1,4,4,18,18,16,17) | 0.7679 fold change | Geometric Coefficient of Variation 32 |
| Pooled Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,1,3,5,20,21,18,19) | 1.8680 fold change | Geometric Coefficient of Variation 103 |
| Pooled Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,20,21,17,18) | NA fold change | — |
| Cohort 1: MultiStem 300, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,20,21,17,18) | NA fold change | — |
| Cohort 1: MultiStem 300, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,2,1,3,2,18,20,17,20) | 2.6199 fold change | — |
| Cohort 1: MultiStem 300, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,1,4,5,21,23,19,20) | 739.2300 fold change | — |
| Cohort 1: MultiStem 300, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,1,4,4,18,18,16,17) | 1.1956 fold change | — |
| Cohort 1: MultiStem 300, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,1,3,5,20,21,18,19) | 2.0264 fold change | — |
| Cohort 1: MultiStem 300 (x3), Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,1,4,4,18,18,16,17) | 0.4459 fold change | Geometric Coefficient of Variation 139 |
| Cohort 1: MultiStem 300 (x3), Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,1,3,5,20,21,18,19) | 2.0549 fold change | Geometric Coefficient of Variation 112 |
| Cohort 1: MultiStem 300 (x3), Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,20,21,17,18) | NA fold change | — |
| Cohort 1: MultiStem 300 (x3), Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,1,4,5,21,23,19,20) | 898.2758 fold change | Geometric Coefficient of Variation 89 |
| Cohort 1: MultiStem 300 (x3), Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,2,1,3,2,18,20,17,20) | 0.5744 fold change | Geometric Coefficient of Variation 52 |
| Cohort 2: MultiStem 750, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,2,1,3,2,18,20,17,20) | 0.3282 fold change | Geometric Coefficient of Variation 2 |
| Cohort 2: MultiStem 750, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,1,4,5,21,23,19,20) | 874.1363 fold change | Geometric Coefficient of Variation 1462 |
| Cohort 2: MultiStem 750, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,1,3,5,20,21,18,19) | 1.0940 fold change | Geometric Coefficient of Variation 91 |
| Cohort 2: MultiStem 750, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,20,21,17,18) | NA fold change | — |
| Cohort 2: MultiStem 750, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,1,4,4,18,18,16,17) | 0.2474 fold change | Geometric Coefficient of Variation 4517 |
| Cohort 3: MultiStem 750, MultiStem 750 | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,1,3,5,20,21,18,19) | 1.2196 fold change | Geometric Coefficient of Variation 158 |
| Cohort 3: MultiStem 750, MultiStem 750 | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,2,1,3,2,18,20,17,20) | 1.0704 fold change | Geometric Coefficient of Variation 220 |
| Cohort 3: MultiStem 750, MultiStem 750 | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,20,21,17,18) | 0.9947 fold change | Geometric Coefficient of Variation 171 |
| Cohort 3: MultiStem 750, MultiStem 750 | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,1,4,4,18,18,16,17) | 0.6473 fold change | Geometric Coefficient of Variation 277 |
| Cohort 3: MultiStem 750, MultiStem 750 | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,1,4,5,21,23,19,20) | 576.5796 fold change | Geometric Coefficient of Variation 237 |
| Cohort 3: MultiStem 750, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,2,1,3,2,18,20,17,20) | 0.7462 fold change | Geometric Coefficient of Variation 235 |
| Cohort 3: MultiStem 750, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,1,3,5,20,21,18,19) | 0.8179 fold change | Geometric Coefficient of Variation 314 |
| Cohort 3: MultiStem 750, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,1,4,5,21,23,19,20) | 476.1504 fold change | Geometric Coefficient of Variation 222 |
| Cohort 3: MultiStem 750, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,20,21,17,18) | 0.8269 fold change | Geometric Coefficient of Variation 310 |
| Cohort 3: MultiStem 750, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,1,4,4,18,18,16,17) | 0.8486 fold change | Geometric Coefficient of Variation 149 |
| Cohort 3: Placebo, MultiStem 750 | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,2,1,3,2,18,20,17,20) | 0.8598 fold change | Geometric Coefficient of Variation 227 |
| Cohort 3: Placebo, MultiStem 750 | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,1,3,5,20,21,18,19) | 1.0541 fold change | Geometric Coefficient of Variation 166 |
| Cohort 3: Placebo, MultiStem 750 | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,1,4,4,18,18,16,17) | 0.5473 fold change | Geometric Coefficient of Variation 309 |
| Cohort 3: Placebo, MultiStem 750 | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,20,21,17,18) | 0.8788 fold change | Geometric Coefficient of Variation 293 |
| Cohort 3: Placebo, MultiStem 750 | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,1,4,5,21,23,19,20) | 513.2139 fold change | Geometric Coefficient of Variation 208 |
| Cohort 3: Placebo, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 16 (n=2,3,1,4,4,18,18,16,17) | 0.5275 fold change | Geometric Coefficient of Variation 243 |
| Cohort 3: Placebo, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Baseline (n=2,3,1,4,5,21,23,19,20) | 821.1953 fold change | Geometric Coefficient of Variation 220 |
| Cohort 3: Placebo, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 12 (n=0,0,0,0,0,20,21,17,18) | 0.5279 fold change | Geometric Coefficient of Variation 171 |
| Cohort 3: Placebo, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 4 (n=2,3,1,3,5,20,21,18,19) | 0.6722 fold change | Geometric Coefficient of Variation 193 |
| Cohort 3: Placebo, Placebo | Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16 | Change at Week 8 (n=1,2,1,3,2,18,20,17,20) | 0.3479 fold change | Geometric Coefficient of Variation 242 |
Comparison: Pooled MultiStem versus Pooled Placebo (Week 8)p-value: 0.9180% CI: [1.02, 2.14]Mixed Models Analysis
Comparison: Cohort 3 MM versus Cohort 3 PP (Week 12)p-value: 0.8180% CI: [0.86, 2.23]Mixed Models Analysis
Comparison: Cohort 3 MP versus Cohort 3 PP (Week 12)p-value: 0.4480% CI: [0.59, 1.51]Mixed Models Analysis
Comparison: Cohort 3 PM versus Cohort 3 PP (Week 12)p-value: 0.6780% CI: [0.72, 1.94]Mixed Models Analysis
Comparison: Cohort 3 MM versus Cohort 3 PP (Week 16)p-value: 0.6280% CI: [0.68, 1.84]Mixed Models Analysis
Comparison: Pooled MultiStem versus Pooled Placebo (Week 4)p-value: 0.5380% CI: [0.73, 1.42]Mixed Models Analysis
Comparison: Cohort 3 MP versus Cohort 3 PP (Week 16)p-value: 0.9580% CI: [0.58, 1.57]Mixed Models Analysis
Comparison: Cohort 3 PM versus Cohort 3 PP (Week 16)p-value: 0.380% CI: [0.49, 1.36]Mixed Models Analysis
Secondary
Number of Participants With Laboratory Test Abnormalities
The total number of participants with laboratory test abnormalities with or without regard to baseline abnormality was assessed. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte sedimentation rate); chemistry (blood urea nitrogen and creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase); other (follicle-stimulating hormone, human chorionic gonadotropin, stool microbiology, creatinine kinase, direct bilirubin, indirect bilirubin, gamma-glutamyl transferase, international normalized ratio.
Time frame: Baseline up to Week 24
Population: The safety analysis population consisted of all participants who received at least 1 dose of study medication; n=the number of participants analyzed at that time point in the respective arms.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled MultiStem | Number of Participants With Laboratory Test Abnormalities | Normal/Abnormal Baseline(n=2,3,2,4,6,23,25,19,21) | 2 participants |
| Pooled MultiStem | Number of Participants With Laboratory Test Abnormalities | Abnormal Baseline (n=2,3,2,2,3,22,19,15,18) | 1 participants |
| Pooled MultiStem | Number of Participants With Laboratory Test Abnormalities | Normal Baseline (n=2,3,2,4,6,23,25,19,21) | 2 participants |
| Pooled Placebo | Number of Participants With Laboratory Test Abnormalities | Abnormal Baseline (n=2,3,2,2,3,22,19,15,18) | 1 participants |
| Pooled Placebo | Number of Participants With Laboratory Test Abnormalities | Normal Baseline (n=2,3,2,4,6,23,25,19,21) | 2 participants |
| Pooled Placebo | Number of Participants With Laboratory Test Abnormalities | Normal/Abnormal Baseline(n=2,3,2,4,6,23,25,19,21) | 2 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Laboratory Test Abnormalities | Normal Baseline (n=2,3,2,4,6,23,25,19,21) | 1 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Laboratory Test Abnormalities | Normal/Abnormal Baseline(n=2,3,2,4,6,23,25,19,21) | 1 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Laboratory Test Abnormalities | Abnormal Baseline (n=2,3,2,2,3,22,19,15,18) | 1 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Laboratory Test Abnormalities | Abnormal Baseline (n=2,3,2,2,3,22,19,15,18) | 1 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Laboratory Test Abnormalities | Normal/Abnormal Baseline(n=2,3,2,4,6,23,25,19,21) | 4 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Laboratory Test Abnormalities | Normal Baseline (n=2,3,2,4,6,23,25,19,21) | 3 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Laboratory Test Abnormalities | Normal Baseline (n=2,3,2,4,6,23,25,19,21) | 4 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Laboratory Test Abnormalities | Normal/Abnormal Baseline(n=2,3,2,4,6,23,25,19,21) | 4 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Laboratory Test Abnormalities | Abnormal Baseline (n=2,3,2,2,3,22,19,15,18) | 2 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Laboratory Test Abnormalities | Normal Baseline (n=2,3,2,4,6,23,25,19,21) | 9 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Laboratory Test Abnormalities | Normal/Abnormal Baseline(n=2,3,2,4,6,23,25,19,21) | 14 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Laboratory Test Abnormalities | Abnormal Baseline (n=2,3,2,2,3,22,19,15,18) | 7 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Laboratory Test Abnormalities | Abnormal Baseline (n=2,3,2,2,3,22,19,15,18) | 4 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Laboratory Test Abnormalities | Normal/Abnormal Baseline(n=2,3,2,4,6,23,25,19,21) | 20 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Laboratory Test Abnormalities | Normal Baseline (n=2,3,2,4,6,23,25,19,21) | 16 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Laboratory Test Abnormalities | Normal Baseline (n=2,3,2,4,6,23,25,19,21) | 12 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Laboratory Test Abnormalities | Abnormal Baseline (n=2,3,2,2,3,22,19,15,18) | 4 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Laboratory Test Abnormalities | Normal/Abnormal Baseline(n=2,3,2,4,6,23,25,19,21) | 15 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Laboratory Test Abnormalities | Normal Baseline (n=2,3,2,4,6,23,25,19,21) | 13 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Laboratory Test Abnormalities | Abnormal Baseline (n=2,3,2,2,3,22,19,15,18) | 6 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Laboratory Test Abnormalities | Normal/Abnormal Baseline(n=2,3,2,4,6,23,25,19,21) | 17 participants |
Secondary
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Vital signs assessment included pulse rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP). Criteria for vital sign values meeting potential clinical concern included: SBP \<90 millimeters of mercury (mm Hg) and \>=30 mm Hg increase/decrease from baseline, DBP \<50 mm Hg and \>=20 mm Hg increase/decrease from baseline, pulse rate \<40 or \>120 beats per minute (bpm),
Time frame: Baseline up to Week 52
Population: The safety analysis population consisted of all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled MultiStem | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate <40 bpm | 0 participants |
| Pooled MultiStem | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP <50 mm Hg | 0 participants |
| Pooled MultiStem | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP <90 mm Hg | 0 participants |
| Pooled MultiStem | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate >120 bpm | 0 participants |
| Pooled MultiStem | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Increase From Baseline | 0 participants |
| Pooled MultiStem | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Increase From Baseline | 2 participants |
| Pooled MultiStem | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Decrease From Baseline | 0 participants |
| Pooled MultiStem | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Decrease From Baseline | 1 participants |
| Pooled Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate >120 bpm | 0 participants |
| Pooled Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP <50 mm Hg | 0 participants |
| Pooled Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Decrease From Baseline | 0 participants |
| Pooled Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate <40 bpm | 0 participants |
| Pooled Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Increase From Baseline | 0 participants |
| Pooled Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP <90 mm Hg | 0 participants |
| Pooled Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Decrease From Baseline | 1 participants |
| Pooled Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Increase From Baseline | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Decrease From Baseline | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate >120 bpm | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Increase From Baseline | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP <50 mm Hg | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Decrease From Baseline | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate <40 bpm | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP <90 mm Hg | 0 participants |
| Cohort 1: MultiStem 300, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Increase From Baseline | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP <50 mm Hg | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Decrease From Baseline | 1 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Decrease From Baseline | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate <40 bpm | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate >120 bpm | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Increase From Baseline | 1 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP <90 mm Hg | 0 participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Increase From Baseline | 1 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Increase From Baseline | 1 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate >120 bpm | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Decrease From Baseline | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Increase From Baseline | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP <50 mm Hg | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Decrease From Baseline | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate <40 bpm | 0 participants |
| Cohort 2: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP <90 mm Hg | 2 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP <50 mm Hg | 0 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Decrease From Baseline | 6 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate <40 bpm | 0 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Decrease From Baseline | 1 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Increase From Baseline | 1 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate >120 bpm | 3 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Increase From Baseline | 3 participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP <90 mm Hg | 0 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Decrease From Baseline | 1 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP <90 mm Hg | 0 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate <40 bpm | 0 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Increase From Baseline | 0 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Increase From Baseline | 3 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate >120 bpm | 0 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP <50 mm Hg | 1 participants |
| Cohort 3: MultiStem 750, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Decrease From Baseline | 1 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP <90 mm Hg | 0 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP <50 mm Hg | 0 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate <40 bpm | 0 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate >120 bpm | 1 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Increase From Baseline | 1 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Increase From Baseline | 2 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Decrease From Baseline | 3 participants |
| Cohort 3: Placebo, MultiStem 750 | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Decrease From Baseline | 1 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Decrease From Baseline | 0 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Decrease From Baseline | 1 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP >=20 mm Hg Increase From Baseline | 4 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP >=30 mm Hg Increase From Baseline | 2 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate >120 bpm | 0 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine Pulse Rate <40 bpm | 0 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine DBP <50 mm Hg | 0 participants |
| Cohort 3: Placebo, Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Supine SBP <90 mm Hg | 0 participants |
Secondary
Percentage of Participants in Clinical Remission at Week 8
Clinical remission is defined as a total Mayo score of 2 points or lower, with no individual subscores exceeding 1 point.
Time frame: Week 8
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pooled MultiStem | Percentage of Participants in Clinical Remission at Week 8 | 0 percentage of participants |
| Pooled Placebo | Percentage of Participants in Clinical Remission at Week 8 | 0 percentage of participants |
| Cohort 1: MultiStem 300, Placebo | Percentage of Participants in Clinical Remission at Week 8 | 0 percentage of participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Percentage of Participants in Clinical Remission at Week 8 | 0 percentage of participants |
| Cohort 2: MultiStem 750, Placebo | Percentage of Participants in Clinical Remission at Week 8 | 0 percentage of participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Percentage of Participants in Clinical Remission at Week 8 | 0 percentage of participants |
| Cohort 3: MultiStem 750, Placebo | Percentage of Participants in Clinical Remission at Week 8 | 8.0 percentage of participants |
| Cohort 3: Placebo, MultiStem 750 | Percentage of Participants in Clinical Remission at Week 8 | 0 percentage of participants |
| Cohort 3: Placebo, Placebo | Percentage of Participants in Clinical Remission at Week 8 | 19.0 percentage of participants |
Comparison: Pooled MultiStem versus Pooled Placebop-value: 0.8580% CI: [0.12, 1.23]Regression, Logistic
Secondary
Percentage of Participants in Clinical Response at Week 8
Clinical response is defined as a decrease in total Mayo score from baseline of at least 3 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.
Time frame: Week 8
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pooled MultiStem | Percentage of Participants in Clinical Response at Week 8 | 50.0 percentage of participants |
| Pooled Placebo | Percentage of Participants in Clinical Response at Week 8 | 33.3 percentage of participants |
| Cohort 1: MultiStem 300, Placebo | Percentage of Participants in Clinical Response at Week 8 | 0 percentage of participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Percentage of Participants in Clinical Response at Week 8 | 0 percentage of participants |
| Cohort 2: MultiStem 750, Placebo | Percentage of Participants in Clinical Response at Week 8 | 0 percentage of participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Percentage of Participants in Clinical Response at Week 8 | 4.3 percentage of participants |
| Cohort 3: MultiStem 750, Placebo | Percentage of Participants in Clinical Response at Week 8 | 24.0 percentage of participants |
| Cohort 3: Placebo, MultiStem 750 | Percentage of Participants in Clinical Response at Week 8 | 15.8 percentage of participants |
| Cohort 3: Placebo, Placebo | Percentage of Participants in Clinical Response at Week 8 | 42.9 percentage of participants |
Comparison: Pooled MultiStem versus Pooled Placebop-value: 0.9680% CI: [0.12, 0.73]Regression, Logistic
Secondary
Percentage of Participants in Endoscopic Remission at Week 8
Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding). Endoscopic remission is defined as modified Baron Endoscopic Score equal to 0.
Time frame: Week 8
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pooled MultiStem | Percentage of Participants in Endoscopic Remission at Week 8 | 0 percentage of participants |
| Pooled Placebo | Percentage of Participants in Endoscopic Remission at Week 8 | 0 percentage of participants |
| Cohort 1: MultiStem 300, Placebo | Percentage of Participants in Endoscopic Remission at Week 8 | 0 percentage of participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Percentage of Participants in Endoscopic Remission at Week 8 | 0 percentage of participants |
| Cohort 2: MultiStem 750, Placebo | Percentage of Participants in Endoscopic Remission at Week 8 | 16.7 percentage of participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Percentage of Participants in Endoscopic Remission at Week 8 | 4.3 percentage of participants |
| Cohort 3: MultiStem 750, Placebo | Percentage of Participants in Endoscopic Remission at Week 8 | 4.0 percentage of participants |
| Cohort 3: Placebo, MultiStem 750 | Percentage of Participants in Endoscopic Remission at Week 8 | 0 percentage of participants |
| Cohort 3: Placebo, Placebo | Percentage of Participants in Endoscopic Remission at Week 8 | 9.5 percentage of participants |
Comparison: Pooled MultiStem versus Pooled Placebop-value: 0.5780% CI: [0.22, 3.07]Regression, Logistic
Secondary
Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16
Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes). A decrease from baseline score indicates improvement.
Time frame: Baseline, Weeks 4, 8, 12 and 16
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled MultiStem | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 12 | NA percentage of participants |
| Pooled MultiStem | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 8 | 100 percentage of participants |
| Pooled MultiStem | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 4 | 100 percentage of participants |
| Pooled MultiStem | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 16 | 100 percentage of participants |
| Pooled Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 16 | 66.7 percentage of participants |
| Pooled Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 12 | NA percentage of participants |
| Pooled Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 8 | 33.3 percentage of participants |
| Pooled Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 4 | 66.7 percentage of participants |
| Cohort 1: MultiStem 300, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 16 | 0 percentage of participants |
| Cohort 1: MultiStem 300, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 8 | 0 percentage of participants |
| Cohort 1: MultiStem 300, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 12 | NA percentage of participants |
| Cohort 1: MultiStem 300, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 4 | 0 percentage of participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 8 | 0 percentage of participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 12 | NA percentage of participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 16 | 25.0 percentage of participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 4 | 0 percentage of participants |
| Cohort 2: MultiStem 750, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 4 | 40.0 percentage of participants |
| Cohort 2: MultiStem 750, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 8 | 40.0 percentage of participants |
| Cohort 2: MultiStem 750, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 12 | NA percentage of participants |
| Cohort 2: MultiStem 750, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 16 | 60.0 percentage of participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 8 | 34.8 percentage of participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 4 | 43.5 percentage of participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 16 | 47.6 percentage of participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 12 | 54.5 percentage of participants |
| Cohort 3: MultiStem 750, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 8 | 48.0 percentage of participants |
| Cohort 3: MultiStem 750, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 16 | 58.3 percentage of participants |
| Cohort 3: MultiStem 750, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 4 | 48.0 percentage of participants |
| Cohort 3: MultiStem 750, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 12 | 60.0 percentage of participants |
| Cohort 3: Placebo, MultiStem 750 | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 12 | 41.2 percentage of participants |
| Cohort 3: Placebo, MultiStem 750 | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 8 | 31.6 percentage of participants |
| Cohort 3: Placebo, MultiStem 750 | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 16 | 35.3 percentage of participants |
| Cohort 3: Placebo, MultiStem 750 | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 4 | 21.1 percentage of participants |
| Cohort 3: Placebo, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 12 | 52.6 percentage of participants |
| Cohort 3: Placebo, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 8 | 47.6 percentage of participants |
| Cohort 3: Placebo, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 4 | 38.1 percentage of participants |
| Cohort 3: Placebo, Placebo | Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16 | Week 16 | 47.4 percentage of participants |
Comparison: Pooled MultiStem versus Pooled Placebo (Week 4)p-value: 0.0580% CI: [1.21, 4.24]Regression, Logistic
Comparison: Pooled MultiStem versus Pooled Placebo (Week 8)p-value: 0.4380% CI: [0.61, 1.95]Regression, Logistic
Comparison: Cohort 3 MM versus Cohort 3 PP (Week 12)p-value: 0.4480% CI: [0.45, 2.76]Regression, Logistic
Comparison: Cohort 3 MP versus Cohort 3 PP (Week 12)p-value: 0.3880% CI: [0.5, 3.04]Regression, Logistic
Comparison: Cohort 3 PM versus Cohort 3 PP (Week 12)p-value: 0.8980% CI: [0.14, 1.04]Regression, Logistic
Comparison: Cohort 3 MM versus Cohort 3 PP (Week 16)p-value: 0.4780% CI: [0.45, 2.42]Regression, Logistic
Comparison: Cohort 3 MP versus Cohort 3 PP (Week 16)p-value: 0.2480% CI: [0.7, 3.57]Regression, Logistic
Comparison: Cohort 3 PM versus Cohort 3 PP (Week 16)p-value: 0.8180% CI: [0.22, 1.32]Regression, Logistic
Secondary
Percentage of Participants With Endoscopic Response at Week 8
Endoscopic response is defined as a decrease in modified Baron endoscopic score from baseline of at least 2 points.
Time frame: Week 8
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pooled MultiStem | Percentage of Participants With Endoscopic Response at Week 8 | 0 percentage of participants |
| Pooled Placebo | Percentage of Participants With Endoscopic Response at Week 8 | 0 percentage of participants |
| Cohort 1: MultiStem 300, Placebo | Percentage of Participants With Endoscopic Response at Week 8 | 0 percentage of participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Percentage of Participants With Endoscopic Response at Week 8 | 0 percentage of participants |
| Cohort 2: MultiStem 750, Placebo | Percentage of Participants With Endoscopic Response at Week 8 | 0 percentage of participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Percentage of Participants With Endoscopic Response at Week 8 | 8.7 percentage of participants |
| Cohort 3: MultiStem 750, Placebo | Percentage of Participants With Endoscopic Response at Week 8 | 8.0 percentage of participants |
| Cohort 3: Placebo, MultiStem 750 | Percentage of Participants With Endoscopic Response at Week 8 | 10.5 percentage of participants |
| Cohort 3: Placebo, Placebo | Percentage of Participants With Endoscopic Response at Week 8 | 19.0 percentage of participants |
Comparison: Pooled MultiStem versus Pooled Placebop-value: 0.8480% CI: [0.2, 1.24]Regression, Logistic
Secondary
Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16
Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes).
Time frame: Week 4, 8, 12 and 16
Population: The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pooled MultiStem | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 8 | 50.0 percentage of participants |
| Pooled MultiStem | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 4 | 50.0 percentage of participants |
| Pooled MultiStem | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 12 | NA percentage of participants |
| Pooled MultiStem | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 16 | 50.0 percentage of participants |
| Pooled Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 12 | NA percentage of participants |
| Pooled Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 4 | 66.7 percentage of participants |
| Pooled Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 8 | 66.7 percentage of participants |
| Pooled Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 16 | 100 percentage of participants |
| Cohort 1: MultiStem 300, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 12 | NA percentage of participants |
| Cohort 1: MultiStem 300, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 8 | 50.0 percentage of participants |
| Cohort 1: MultiStem 300, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 4 | 50.0 percentage of participants |
| Cohort 1: MultiStem 300, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 16 | 50.0 percentage of participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 4 | 33.3 percentage of participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 12 | NA percentage of participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 8 | 33.3 percentage of participants |
| Cohort 1: MultiStem 300 (x3), Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 16 | 50.0 percentage of participants |
| Cohort 2: MultiStem 750, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 4 | 40.0 percentage of participants |
| Cohort 2: MultiStem 750, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 8 | 40.0 percentage of participants |
| Cohort 2: MultiStem 750, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 12 | NA percentage of participants |
| Cohort 2: MultiStem 750, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 16 | 40.0 percentage of participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 16 | 47.8 percentage of participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 4 | 52.2 percentage of participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 8 | 47.8 percentage of participants |
| Cohort 3: MultiStem 750, MultiStem 750 | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 12 | 60.9 percentage of participants |
| Cohort 3: MultiStem 750, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 4 | 28.0 percentage of participants |
| Cohort 3: MultiStem 750, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 12 | 40.0 percentage of participants |
| Cohort 3: MultiStem 750, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 8 | 36.0 percentage of participants |
| Cohort 3: MultiStem 750, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 16 | 48.0 percentage of participants |
| Cohort 3: Placebo, MultiStem 750 | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 16 | 36.8 percentage of participants |
| Cohort 3: Placebo, MultiStem 750 | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 4 | 31.6 percentage of participants |
| Cohort 3: Placebo, MultiStem 750 | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 8 | 31.6 percentage of participants |
| Cohort 3: Placebo, MultiStem 750 | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 12 | 47.4 percentage of participants |
| Cohort 3: Placebo, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 16 | 52.4 percentage of participants |
| Cohort 3: Placebo, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 4 | 42.9 percentage of participants |
| Cohort 3: Placebo, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 8 | 47.6 percentage of participants |
| Cohort 3: Placebo, Placebo | Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16 | Week 12 | 42.9 percentage of participants |
Comparison: Pooled MultiStem versus Pooled Placebo (Week 4)p-value: 0.3480% CI: [0.66, 2.19]Regression, Logistic
Comparison: Pooled MultiStem versus Pooled Placebo (Week 8)p-value: 0.3380% CI: [0.68, 2.23]Regression, Logistic
Comparison: Cohort 3 MM versus Cohort 3 PP (Week 12)p-value: 0.180% CI: [0.99, 5.67]Regression, Logistic
Comparison: Cohort 3 MP versus Cohort 3 PP (Week 12)p-value: 0.7480% CI: [0.28, 1.55]Regression, Logistic
Comparison: Cohort 3 PM versus Cohort 3 PP (Week 12)p-value: 0.4880% CI: [0.41, 2.64]Regression, Logistic
Comparison: Cohort 3 MM versus Cohort 3 PP (Week 16)p-value: 0.5880% CI: [0.38, 2.03]Regression, Logistic
Comparison: Cohort 3 MP versus Cohort 3 PP (Week 16)p-value: 0.6880% CI: [0.33, 1.66]Regression, Logistic
Comparison: Cohort 3 PM versus Cohort 3 PP (Week 16)p-value: 0.8480% CI: [0.21, 1.23]Regression, Logistic