COVID-19
Conditions
Keywords
Coronavirus, Prevention, Immune support, stem cells, mesenchymal stem cells, adipose-derived mesenchymal stem cells
Brief summary
Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
Detailed description
This is a Phase II, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 100 patients will be enrolled. Eligible participants are at high or very high exposure risk of contracting COVID-19. The primary endpoint of this study is to provide immune support against COVID-19, measured by the percentage of subjects that develop symptoms of COVID-19. In addition, participants will be monitored for overall clinical status by standard clinical laboratories and inflammatory markers. Participants will complete Short Form Health Survey (SF-36) and depression module (PHQ-9) questionnaires.
Interventions
BIOLOGICALHB-adMSCs
Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
OTHERPlacebos
Saline
Sponsors
Hope Biosciences Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Men, and women 18 years of age or older * Participant works in a capacity that is characterized as high-risk or very high-risk * High-Risk Exposure jobs are those with high potential for exposure to known or suspected sources of COVID-19. * First responders, health care delivery and support staff (e.g., law enforcement, fire fighters, paramedics, doctors, nurses, and other hospital staff who must enter patients' rooms) exposed to individuals potentially having COVID-19. * Mortuary workers involved in preparing (e.g., for burial or cremation) the bodies of people who are known to have, or suspected of having, COVID-19 at the time of their death * Very High-Risk Exposure jobs are those with high potential for exposure to known or suspected sources of COVID-19 during specific medical, postmortem or laboratory procedures. * Health care workers (e.g., doctors, nurses, dentists, paramedics, emergency medical technicians) performing aerosol-generating procedures (e.g., intubation, cough induction procedures, bronchoscopies, some dental procedures and exams or invasive specimen collection) on known or suspected COVID-19 patients. * Health care or laboratory personnel collecting or handling specimens from known or suspected COVID-19 patients (e.g., manipulating cultures from known or suspected COVID-19 patients). * Morgue workers performing autopsies, which generally involve aerosol-generating procedures, on the bodies of people who are known to have, or suspected of having, COVID-19 at the time of their death * No signs or symptoms of infection, including but not limited to, body temperature \>100 F and pulse rate \> 100 BPM. * Subject provides written informed consent prior to initiation of any study procedures.--Agrees to the collection of venous blood per protocol. * Agrees to conformational testing for SARS-CoV-2 before end of study.
Exclusion criteria
* Women who are pregnant or lactating, or those who are not pregnant but do not take effective contraceptive measures * Patients who are participating in other clinical trials or have intake of investigational drug within the previous 30 days; * Inability to provide informed consent or to comply with test requirements; * Any medical disease or condition that, in the opinion of the site PI or sub-investigator, precludes study participation. Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. * Patients who have received a stem cell treatment within one year. * Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Had Symptoms Associated With COVID-19 | Week 0 through Week 26 (End of Study) | Number of subjects who experience symptoms defined to be associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough, etc. |
| Number of Participants That Were Hospitalized Due to COVID-19 Symptoms | Week 0 through Week 26 (End of Study) | Number of subjects that were hospitalized due to COVID-19 symptoms during the conduct of this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leukocyte Differential Count | Week 0 to Week 26 (End of Study) | Change from baseline in Leukocyte Differential Count |
| C Reactive Protein | Week 0 through Week 26 (End of Study) | Change from baseline in C Reactive Protein |
| Tumor Necrosis Factor - Alpha | Week 0 through Week 26 (End of Study) | Change from baseline in TNF alpha |
| Interleukin 6 | Week 0 through Week 26 (End of Study) | Change from baseline in IL-6 |
| Short Form-36 (SF-36) | Week 0 to Week 26 (End of Study) | The Short Form-36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores (including Energy/Fatigue scores, Social Functioning, role limitations due to Physical Health, General Health, Physical Functioning, Pain, Emotional Well-Being, and Emotional Problems) which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. |
| Interleukin 10 | Week 0 through Week 26 (End of Study) | Change from baseline in IL-10 |
| Patient Health Questionnaire (PHQ-9) Scores | Week 0 to Week 26 (End of Study) | The study used PHQ-9 as a depression module, which scores each of the nine DSM-IV criteria as 0 (not at all) to 3 (nearly every day) to monitor the severity of depression. |
Countries
United States
Participant flow
Recruitment details
Selection of subjects was based on the inclusion and exclusion criteria and only those subjects who met all of the inclusion criteria and none of the exclusion criteria, were eligible to participate in the trial. The first participant was enrolled on 05/14/2020 and the last participant was enrolled on 11/04/2020.
Pre-assignment details
A total of 84 subjects were assessed for screening, out of which only 53 were enrolled and 31 were screen failed.
Participants by arm
| Arm | Count |
|---|---|
| Allogeneic HB-adMSCs 200MM Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.
HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells | 19 |
| Allogeneic HB-adMSCs 100MM Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.
HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells | 9 |
| Allogeneic HB-adMSCs 50MM Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.
HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells | 12 |
| Placebo Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Infusions will occur at weeks 0, 2, 6, 10, and 14.
Placebos: Saline | 13 |
| Total | 53 |
Baseline characteristics
| Characteristic | Allogeneic HB-adMSCs 200MM | Allogeneic HB-adMSCs 100MM | Allogeneic HB-adMSCs 50MM | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 45.8 years STANDARD_DEVIATION 13.34 | 47.6 years STANDARD_DEVIATION 9.65 | 43.9 years STANDARD_DEVIATION 12.38 | 42.8 years STANDARD_DEVIATION 9.97 | 44.9 years STANDARD_DEVIATION 11.58 |
| BMI | 31.14 kg/m^2 STANDARD_DEVIATION 8.426 | 30.18 kg/m^2 STANDARD_DEVIATION 6.271 | 27.61 kg/m^2 STANDARD_DEVIATION 3.946 | 26.83 kg/m^2 STANDARD_DEVIATION 6.606 | 29.12 kg/m^2 STANDARD_DEVIATION 6.893 |
| Body Weight | 93.132 kg STANDARD_DEVIATION 29.12 | 85.982 kg STANDARD_DEVIATION 26.72 | 78.662 kg STANDARD_DEVIATION 14.69 | 79.763 kg STANDARD_DEVIATION 23.51 | 85.362 kg STANDARD_DEVIATION 24.84 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 2 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 7 Participants | 10 Participants | 9 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 172.05 cm STANDARD_DEVIATION 10.18 | 167.35 cm STANDARD_DEVIATION 11.6 | 168.38 cm STANDARD_DEVIATION 8.7 | 171.54 cm STANDARD_DEVIATION 11.66 | 170.30 cm STANDARD_DEVIATION 10.39 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 3 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 8 Participants | 7 Participants | 10 Participants | 38 Participants |
| Region of Enrollment United States | 19 participants | 9 participants | 12 participants | 13 participants | 53 participants |
| Sex: Female, Male Female | 10 Participants | 5 Participants | 7 Participants | 8 Participants | 30 Participants |
| Sex: Female, Male Male | 9 Participants | 4 Participants | 5 Participants | 5 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 9 | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 15 / 19 | 5 / 9 | 7 / 12 | 10 / 13 |
| serious Total, serious adverse events | 0 / 19 | 0 / 9 | 0 / 12 | 0 / 13 |
Outcome results
Primary
Number of Participants That Had Symptoms Associated With COVID-19
Number of subjects who experience symptoms defined to be associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough, etc.
Time frame: Week 0 through Week 26 (End of Study)
Population: A total of 37 subjects who completed all 5 infusions.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogeneic HB-adMSCs 200MM | Number of Participants That Had Symptoms Associated With COVID-19 | Number of Subjects with Incidence of COVID-19 Symptoms | 4 Participants |
| Allogeneic HB-adMSCs 200MM | Number of Participants That Had Symptoms Associated With COVID-19 | Number of Subjects with No Incidence of COVID-19 Symptoms | 9 Participants |
| Allogeneic HB-adMSCs 100MM | Number of Participants That Had Symptoms Associated With COVID-19 | Number of Subjects with No Incidence of COVID-19 Symptoms | 5 Participants |
| Allogeneic HB-adMSCs 100MM | Number of Participants That Had Symptoms Associated With COVID-19 | Number of Subjects with Incidence of COVID-19 Symptoms | 0 Participants |
| Allogeneic HB-adMSCs 50MM | Number of Participants That Had Symptoms Associated With COVID-19 | Number of Subjects with Incidence of COVID-19 Symptoms | 0 Participants |
| Allogeneic HB-adMSCs 50MM | Number of Participants That Had Symptoms Associated With COVID-19 | Number of Subjects with No Incidence of COVID-19 Symptoms | 10 Participants |
| Placebo | Number of Participants That Had Symptoms Associated With COVID-19 | Number of Subjects with Incidence of COVID-19 Symptoms | 0 Participants |
| Placebo | Number of Participants That Had Symptoms Associated With COVID-19 | Number of Subjects with No Incidence of COVID-19 Symptoms | 9 Participants |
Primary
Number of Participants That Were Hospitalized Due to COVID-19 Symptoms
Number of subjects that were hospitalized due to COVID-19 symptoms during the conduct of this study.
Time frame: Week 0 through Week 26 (End of Study)
Population: A total of 37 subjects completed all 5 infusions.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogeneic HB-adMSCs 200MM | Number of Participants That Were Hospitalized Due to COVID-19 Symptoms | Number of Subjects that were Hospitalized due to COVID-19 Symptoms | 0 Participants |
| Allogeneic HB-adMSCs 200MM | Number of Participants That Were Hospitalized Due to COVID-19 Symptoms | Number of Subjects that were not Hospitalized due to COVID-19 Symptoms | 13 Participants |
| Allogeneic HB-adMSCs 100MM | Number of Participants That Were Hospitalized Due to COVID-19 Symptoms | Number of Subjects that were not Hospitalized due to COVID-19 Symptoms | 5 Participants |
| Allogeneic HB-adMSCs 100MM | Number of Participants That Were Hospitalized Due to COVID-19 Symptoms | Number of Subjects that were Hospitalized due to COVID-19 Symptoms | 0 Participants |
| Allogeneic HB-adMSCs 50MM | Number of Participants That Were Hospitalized Due to COVID-19 Symptoms | Number of Subjects that were Hospitalized due to COVID-19 Symptoms | 0 Participants |
| Allogeneic HB-adMSCs 50MM | Number of Participants That Were Hospitalized Due to COVID-19 Symptoms | Number of Subjects that were not Hospitalized due to COVID-19 Symptoms | 10 Participants |
| Placebo | Number of Participants That Were Hospitalized Due to COVID-19 Symptoms | Number of Subjects that were Hospitalized due to COVID-19 Symptoms | 0 Participants |
| Placebo | Number of Participants That Were Hospitalized Due to COVID-19 Symptoms | Number of Subjects that were not Hospitalized due to COVID-19 Symptoms | 9 Participants |
Secondary
C Reactive Protein
Change from baseline in C Reactive Protein
Time frame: Week 0 through Week 26 (End of Study)
Population: Number of subjects contributing to analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Allogeneic HB-adMSCs 200MM | C Reactive Protein | Change from baseline | -0.609 mg/L | Standard Error 0.632 |
| Allogeneic HB-adMSCs 200MM | C Reactive Protein | LSMeans | 2.424 mg/L | Standard Error 0.632 |
| Allogeneic HB-adMSCs 100MM | C Reactive Protein | Change from baseline | -1.275 mg/L | Standard Error 1.047 |
| Allogeneic HB-adMSCs 100MM | C Reactive Protein | LSMeans | 1.759 mg/L | Standard Error 1.047 |
| Allogeneic HB-adMSCs 50MM | C Reactive Protein | LSMeans | 2.679 mg/L | Standard Error 0.846 |
| Allogeneic HB-adMSCs 50MM | C Reactive Protein | Change from baseline | -0.354 mg/L | Standard Error 0.846 |
| Placebo | C Reactive Protein | Change from baseline | -0.362 mg/L | Standard Error 0.843 |
| Placebo | C Reactive Protein | LSMeans | 2.671 mg/L | Standard Error 0.843 |
p-value: 0.8171ANCOVA
p-value: 0.5034ANCOVA
p-value: 0.9948ANCOVA
Secondary
Interleukin 10
Change from baseline in IL-10
Time frame: Week 0 through Week 26 (End of Study)
Population: Number of subjects contributing to analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Allogeneic HB-adMSCs 200MM | Interleukin 10 | LSMeans | 0.768 ng/L | Standard Error 0.054 |
| Allogeneic HB-adMSCs 200MM | Interleukin 10 | Change from baseline | 0.088 ng/L | Standard Error 0.054 |
| Allogeneic HB-adMSCs 100MM | Interleukin 10 | Change from baseline | 0.000 ng/L | Standard Error 0.089 |
| Allogeneic HB-adMSCs 100MM | Interleukin 10 | LSMeans | 0.680 ng/L | Standard Error 0.089 |
| Allogeneic HB-adMSCs 50MM | Interleukin 10 | LSMeans | 0.680 ng/L | Standard Error 0.073 |
| Allogeneic HB-adMSCs 50MM | Interleukin 10 | Change from baseline | 0.000 ng/L | Standard Error 0.073 |
| Placebo | Interleukin 10 | LSMeans | 0.688 ng/L | Standard Error 0.073 |
| Placebo | Interleukin 10 | Change from baseline | 0.008 ng/L | Standard Error 0.073 |
p-value: 0.3868ANCOVA
p-value: 0.9429ANCOVA
p-value: 0.9362ANCOVA
Secondary
Interleukin 6
Change from baseline in IL-6
Time frame: Week 0 through Week 26 (End of Study)
Population: Number of subjects contributing to analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Allogeneic HB-adMSCs 200MM | Interleukin 6 | LSMeans | 1.620 ng/L | Standard Error 0.04 |
| Allogeneic HB-adMSCs 200MM | Interleukin 6 | Change from baseline | -0.019 ng/L | Standard Error 0.04 |
| Allogeneic HB-adMSCs 100MM | Interleukin 6 | Change from baseline | -0.019 ng/L | Standard Error 0.065 |
| Allogeneic HB-adMSCs 100MM | Interleukin 6 | LSMeans | 1.620 ng/L | Standard Error 0.065 |
| Allogeneic HB-adMSCs 50MM | Interleukin 6 | LSMeans | 1.732 ng/L | Standard Error 0.053 |
| Allogeneic HB-adMSCs 50MM | Interleukin 6 | Change from baseline | 0.092 ng/L | Standard Error 0.053 |
| Placebo | Interleukin 6 | LSMeans | 1.620 ng/L | Standard Error 0.056 |
| Placebo | Interleukin 6 | Change from baseline | -0.019 ng/L | Standard Error 0.056 |
p-value: 1ANCOVA
p-value: 1ANCOVA
p-value: 0.1713ANCOVA
Secondary
Leukocyte Differential Count
Change from baseline in Leukocyte Differential Count
Time frame: Week 0 to Week 26 (End of Study)
Population: Number of subjects contributing to analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Allogeneic HB-adMSCs 200MM | Leukocyte Differential Count | LSMeans | 6.204 Leukocytes (x10^9/L) | Standard Error 0.296 |
| Allogeneic HB-adMSCs 200MM | Leukocyte Differential Count | Change from baseline | 0.508 Leukocytes (x10^9/L) | Standard Error 0.296 |
| Allogeneic HB-adMSCs 100MM | Leukocyte Differential Count | Change from baseline | -0.179 Leukocytes (x10^9/L) | Standard Error 0.502 |
| Allogeneic HB-adMSCs 100MM | Leukocyte Differential Count | LSMeans | 5.518 Leukocytes (x10^9/L) | Standard Error 0.502 |
| Allogeneic HB-adMSCs 50MM | Leukocyte Differential Count | LSMeans | 6.029 Leukocytes (x10^9/L) | Standard Error 0.393 |
| Allogeneic HB-adMSCs 50MM | Leukocyte Differential Count | Change from baseline | 0.333 Leukocytes (x10^9/L) | Standard Error 0.393 |
| Placebo | Leukocyte Differential Count | LSMeans | 5.951 Leukocytes (x10^9/L) | Standard Error 0.392 |
| Placebo | Leukocyte Differential Count | Change from baseline | 0.255 Leukocytes (x10^9/L) | Standard Error 0.392 |
p-value: 0.6113ANCOVA
p-value: 0.5039ANCOVA
p-value: 0.8903ANCOVA
Secondary
Patient Health Questionnaire (PHQ-9) Scores
The study used PHQ-9 as a depression module, which scores each of the nine DSM-IV criteria as 0 (not at all) to 3 (nearly every day) to monitor the severity of depression.
Time frame: Week 0 to Week 26 (End of Study)
Population: Number of subjects contributing to analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Allogeneic HB-adMSCs 200MM | Patient Health Questionnaire (PHQ-9) Scores | LSMeans | 1.373 Score on a Scale | Standard Error 0.489 |
| Allogeneic HB-adMSCs 200MM | Patient Health Questionnaire (PHQ-9) Scores | Change from baseline | -1.111 Score on a Scale | Standard Error 0.489 |
| Allogeneic HB-adMSCs 100MM | Patient Health Questionnaire (PHQ-9) Scores | Change from baseline | -1.572 Score on a Scale | Standard Error 0.763 |
| Allogeneic HB-adMSCs 100MM | Patient Health Questionnaire (PHQ-9) Scores | LSMeans | 0.912 Score on a Scale | Standard Error 0.763 |
| Allogeneic HB-adMSCs 50MM | Patient Health Questionnaire (PHQ-9) Scores | LSMeans | 1.114 Score on a Scale | Standard Error 0.456 |
| Allogeneic HB-adMSCs 50MM | Patient Health Questionnaire (PHQ-9) Scores | Change from baseline | -1.370 Score on a Scale | Standard Error 0.456 |
| Placebo | Patient Health Questionnaire (PHQ-9) Scores | LSMeans | 1.517 Score on a Scale | Standard Error 0.538 |
| Placebo | Patient Health Questionnaire (PHQ-9) Scores | Change from baseline | -0.967 Score on a Scale | Standard Error 0.538 |
p-value: 0.8628ANCOVA
p-value: 0.5257ANCOVA
p-value: 0.5467ANCOVA
Secondary
Short Form-36 (SF-36)
The Short Form-36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores (including Energy/Fatigue scores, Social Functioning, role limitations due to Physical Health, General Health, Physical Functioning, Pain, Emotional Well-Being, and Emotional Problems) which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time frame: Week 0 to Week 26 (End of Study)
Population: Number of subjects contributing to analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Avg. Role Limitations Due to Emotional Problems - Change from baseline | 3.833 Score on a Scale | Standard Error 2.334 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Average Physical Functioning - Change from baseline | 1.267 Score on a Scale | Standard Error 2.66 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Avg. Role Limitations Due to Physical Health | 94.711 Score on a Scale | Standard Error 2.326 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Average Emotional Well Being | 87.057 Score on a Scale | Standard Error 2.566 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Average Energy/Fatigue - Change from baseline | 7.140 Score on a Scale | Standard Error 5.139 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Average Emotional Well Being - Change from baseline | 4.057 Score on a Scale | Standard Error 2.566 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Avg. Role Limitations Due to Physical Health - Change from baseline | 1.742 Score on a Scale | Standard Error 2.326 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Average Physical Functioning | 92.361 Score on a Scale | Standard Error 2.66 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Average Social Functioning | 98.950 Score on a Scale | Standard Error 2.19 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Average General Health | 76.481 Score on a Scale | Standard Error 3.818 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Average Energy/Fatigue | 68.858 Score on a Scale | Standard Error 5.139 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Average Pain - Change from baseline | 11.212 Score on a Scale | Standard Error 3.746 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Average Social Functioning - Change from baseline | 7.153 Score on a Scale | Standard Error 2.19 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Average General Health - Change from baseline | 1.481 Score on a Scale | Standard Error 3.818 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Average Pain | 90.744 Score on a Scale | Standard Error 3.746 |
| Allogeneic HB-adMSCs 200MM | Short Form-36 (SF-36) | Avg. Role Limitations Due to Emotional Problems | 99.667 Score on a Scale | Standard Error 2.334 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Average Pain - Change from baseline | 5.169 Score on a Scale | Standard Error 6.291 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Avg. Role Limitations Due to Emotional Problems - Change from baseline | 1.166 Score on a Scale | Standard Error 3.654 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Average Social Functioning | 90.711 Score on a Scale | Standard Error 3.556 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Average Physical Functioning - Change from baseline | 5.712 Score on a Scale | Standard Error 4.42 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Average Physical Functioning | 96.806 Score on a Scale | Standard Error 4.42 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Average Social Functioning - Change from baseline | -1.086 Score on a Scale | Standard Error 3.556 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Average Energy/Fatigue | 78.346 Score on a Scale | Standard Error 7.672 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Average Emotional Well Being - Change from baseline | 5.413 Score on a Scale | Standard Error 4.096 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Avg. Role Limitations Due to Physical Health | 100.00 Score on a Scale | Standard Error 4.393 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Average Energy/Fatigue - Change from baseline | 16.628 Score on a Scale | Standard Error 7.672 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Average Emotional Well Being | 88.413 Score on a Scale | Standard Error 4.096 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Average General Health | 78.857 Score on a Scale | Standard Error 6.274 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Avg. Role Limitations Due to Physical Health - Change from baseline | 14.280 Score on a Scale | Standard Error 4.393 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Average Pain | 84.700 Score on a Scale | Standard Error 6.291 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Average General Health - Change from baseline | 3.857 Score on a Scale | Standard Error 6.274 |
| Allogeneic HB-adMSCs 100MM | Short Form-36 (SF-36) | Avg. Role Limitations Due to Emotional Problems | 97.000 Score on a Scale | Standard Error 3.654 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Average Pain - Change from baseline | 11.635 Score on a Scale | Standard Error 4.124 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Average Energy/Fatigue | 75.849 Score on a Scale | Standard Error 5.125 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Average Energy/Fatigue - Change from baseline | 14.130 Score on a Scale | Standard Error 5.125 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Average Social Functioning | 99.864 Score on a Scale | Standard Error 2.503 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Average Social Functioning - Change from baseline | 8.067 Score on a Scale | Standard Error 2.503 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Avg. Role Limitations Due to Physical Health | 98.727 Score on a Scale | Standard Error 2.587 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Avg. Role Limitations Due to Physical Health - Change from baseline | 5.758 Score on a Scale | Standard Error 2.587 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Average General Health | 81.016 Score on a Scale | Standard Error 4.196 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Average General Health - Change from baseline | 6.016 Score on a Scale | Standard Error 4.196 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Avg. Role Limitations Due to Emotional Problems | 97.000 Score on a Scale | Standard Error 2.456 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Avg. Role Limitations Due to Emotional Problems - Change from baseline | 1.166 Score on a Scale | Standard Error 2.456 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Average Physical Functioning | 93.598 Score on a Scale | Standard Error 2.939 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Average Physical Functioning - Change from baseline | 2.504 Score on a Scale | Standard Error 2.939 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Average Emotional Well Being | 86.992 Score on a Scale | Standard Error 2.739 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Average Emotional Well Being - Change from baseline | 3.992 Score on a Scale | Standard Error 2.739 |
| Allogeneic HB-adMSCs 50MM | Short Form-36 (SF-36) | Average Pain | 91.166 Score on a Scale | Standard Error 4.124 |
| Placebo | Short Form-36 (SF-36) | Average Physical Functioning - Change from baseline | -1.166 Score on a Scale | Standard Error 3.123 |
| Placebo | Short Form-36 (SF-36) | Avg. Role Limitations Due to Emotional Problems | 97.000 Score on a Scale | Standard Error 2.601 |
| Placebo | Short Form-36 (SF-36) | Average General Health | 75.518 Score on a Scale | Standard Error 4.454 |
| Placebo | Short Form-36 (SF-36) | Avg. Role Limitations Due to Physical Health - Change from baseline | 5.862 Score on a Scale | Standard Error 2.737 |
| Placebo | Short Form-36 (SF-36) | Average Social Functioning | 98.430 Score on a Scale | Standard Error 2.484 |
| Placebo | Short Form-36 (SF-36) | Average Emotional Well Being | 84.724 Score on a Scale | Standard Error 2.863 |
| Placebo | Short Form-36 (SF-36) | Avg. Role Limitations Due to Physical Health | 98.831 Score on a Scale | Standard Error 2.737 |
| Placebo | Short Form-36 (SF-36) | Average Social Functioning - Change from baseline | 6.633 Score on a Scale | Standard Error 2.484 |
| Placebo | Short Form-36 (SF-36) | Average Energy/Fatigue - Change from baseline | 7.848 Score on a Scale | Standard Error 5.826 |
| Placebo | Short Form-36 (SF-36) | Average Emotional Well Being - Change from baseline | 1.724 Score on a Scale | Standard Error 2.863 |
| Placebo | Short Form-36 (SF-36) | Average General Health - Change from baseline | 0.518 Score on a Scale | Standard Error 4.454 |
| Placebo | Short Form-36 (SF-36) | Average Energy/Fatigue | 69.567 Score on a Scale | Standard Error 5.826 |
| Placebo | Short Form-36 (SF-36) | Average Physical Functioning | 89.928 Score on a Scale | Standard Error 3.123 |
| Placebo | Short Form-36 (SF-36) | Average Pain - Change from baseline | -0.466 Score on a Scale | Standard Error 4.377 |
| Placebo | Short Form-36 (SF-36) | Avg. Role Limitations Due to Emotional Problems - Change from baseline | 1.166 Score on a Scale | Standard Error 2.601 |
| Placebo | Short Form-36 (SF-36) | Average Pain | 79.065 Score on a Scale | Standard Error 4.377 |
Comparison: Average Energy/Fatigue - Treatment Contrastp-value: 0.9333ANCOVA
Comparison: Average Energy/Fatigue - Treatment Contrastp-value: 0.3627ANCOVA
Comparison: Average Energy/Fatigue - Treatment Contrastp-value: 0.416ANCOVA
Comparison: Average Social Functioning - Treatment Contrastp-value: 0.8768ANCOVA
Comparison: Average Social Functioning - Treatment Contrastp-value: 0.0869ANCOVA
Comparison: Average Social Functioning - Treatment Contrastp-value: 0.6864ANCOVA
Comparison: Avg. Role Limitations Due to Physical Health - Treatment Contrastp-value: 0.2587ANCOVA
Comparison: Avg. Role Limitations Due to Physical Health - Treatment Contrastp-value: 0.125ANCOVA
Comparison: Avg. Role Limitations Due to Physical Health - Treatment Contrastp-value: 0.978ANCOVA
Comparison: Average General Health - Treatment Contrastp-value: 0.8721ANCOVA
Comparison: Average General Health - Treatment Contrastp-value: 0.6694ANCOVA
Comparison: Average General Health - Treatment Contrastp-value: 0.3733ANCOVA
Comparison: Average Physical Functioning - Treatment Contrastp-value: 0.5594ANCOVA
Comparison: Average Physical Functioning - Treatment Contrastp-value: 0.2127ANCOVA
Comparison: Average Physical Functioning - Treatment Contrastp-value: 0.4012ANCOVA
Comparison: Average Pain - Treatment Contrastp-value: 0.0521ANCOVA
Comparison: Average Pain - Treatment Contrastp-value: 0.4704ANCOVA
Comparison: Average Pain - Treatment Contrastp-value: 0.0544ANCOVA
Comparison: Average Emotional Well Being - Treatment Contrastp-value: 0.5535ANCOVA
Comparison: Average Emotional Well Being - Treatment Contrastp-value: 0.4642ANCOVA
Comparison: Average Emotional Well Being - Treatment Contrastp-value: 0.5692ANCOVA
Comparison: Avg. Role Limitations Due to Emotional Problems - Treatment Contrastp-value: 0.4642ANCOVA
Comparison: Avg. Role Limitations Due to Emotional Problems - Treatment Contrastp-value: 1ANCOVA
Comparison: Avg. Role Limitations Due to Emotional Problems - Treatment Contrastp-value: 1ANCOVA
Secondary
Tumor Necrosis Factor - Alpha
Change from baseline in TNF alpha
Time frame: Week 0 through Week 26 (End of Study)
Population: Number of subjects contributing to analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Allogeneic HB-adMSCs 200MM | Tumor Necrosis Factor - Alpha | LSMeans | 1.175 ng/L | Standard Error 0.091 |
| Allogeneic HB-adMSCs 200MM | Tumor Necrosis Factor - Alpha | Change from baseline | -0.316 ng/L | Standard Error 0.091 |
| Allogeneic HB-adMSCs 100MM | Tumor Necrosis Factor - Alpha | Change from baseline | -0.540 ng/L | Standard Error 0.15 |
| Allogeneic HB-adMSCs 100MM | Tumor Necrosis Factor - Alpha | LSMeans | 0.951 ng/L | Standard Error 0.15 |
| Allogeneic HB-adMSCs 50MM | Tumor Necrosis Factor - Alpha | LSMeans | 1.173 ng/L | Standard Error 0.123 |
| Allogeneic HB-adMSCs 50MM | Tumor Necrosis Factor - Alpha | Change from baseline | -0.318 ng/L | Standard Error 0.123 |
| Placebo | Tumor Necrosis Factor - Alpha | LSMeans | 0.996 ng/L | Standard Error 0.124 |
| Placebo | Tumor Necrosis Factor - Alpha | Change from baseline | -0.495 ng/L | Standard Error 0.124 |
p-value: 0.2641ANCOVA
p-value: 0.822ANCOVA
p-value: 0.3097ANCOVA