Osteoarthritis
Conditions
Keywords
mesenchymal stem cells, corticosteroids, bone marrow aspiration, adipose-derived stromal vascular fraction
Brief summary
The study is a multicenter trial conducted to compare the effectiveness of an injection of a corticosteroid control to mesenchymal stem cell (MSC) preparations from autologous bone marrow concentrate (BMAC), adipose derived stem cells in the form of Stromal Vascular Fraction (SVF), and third-party human mesenchymal stem cells manufactured from umbilical cord tissue (UCT) for the treatment of unilateral Knee Osteoarthritis (OA). The study will be conducted in 4 sites in the United States, and a total of 480 participants will be enrolled in this study.
Detailed description
Primary osteoarthritis is a debilitating disease characterized by extensive damage to the joints and excruciating pain leading to loss of activity and depression. Despite advances in diagnosis and relatively efficient control of nociception, to date, the quest for the development of a disease modifying osteoarthritis drug has proven unsuccessful. The potential of mesenchymal stem cells (MSCs) to inhibit inflammation while promoting healing makes them amenable for the treatment of various ailments ranging from cancer to genetic diseases. In orthopedic practice, autologous stem cell injections are performed to alleviate the pain associated with osteoarthritis. A serious gap in knowledge remains whether the currently used cellular treatments are beneficial in the long term and if one cell therapy outperforms another. The most popular form of autologous MSC therapy has been through the use of autologous bone marrow concentrate (BMAC). The rationale is that when a sample of bone marrow aspirate (BMA) is collected and the components that are not beneficial to the joint are filtered out (i.e. red blood cells, neutrophils, etc.) the remaining concentrate (MSCs, platelets, interleukins, etc) can have a healing effect on the environment in which it is injected. However it is still unknown as to how effective BMAC is for treating orthopedic conditions compared to other MSC procedures and the most important components of the BMAC mixture that could aid patients suffering from osteoarthritis. Adipose tissue has been found to have a large amount of MSCs versus that in bone marrow. These cells are currently being used in a variety of clinical research studies within the regenerative medicine field. Through a tissue process which includes washing and centrifuging, the cellular components can be extracted as a cell pellet, which is also known as stromal vascular fraction (SVF). Adipose derived SVF is obtained via liposuction, or the removal of adipose tissue via a suction method. Although the use of various stem cell preparations for knee osteoarthritis has become increasingly prevalent, well-designed studies with conclusive proof of comparative effectiveness and identification of the optimal cell source and dose have not been performed. This study is the first randomized study comparing three types of cellular treatments to corticosteroids. The main objective of the study is to identify a superior source of stem cells for the treatment of osteoarthritis and validate its advantages over corticosteroid injections as the traditional gold standard treatment. Participants will be randomized study arms with different types of MSCs (bone marrow derived MSC, adipose derived MSC, and umbilical cord tissue MSC) and then will be further randomized to receive an injection of the MSC type they were initially assigned to or corticosteroid. Participants randomized to bone marrow derived MSC or adipose derived MSC will undergo a procedure (bone marrow aspiration or liposuction). Participants will be blinded to whether they receive the MSC or corticosteroid injection.
Interventions
BIOLOGICALBone Marrow Derived MSCs
Autologous bone marrow concentrate (BMAC) is a standard orthobiologic injection for knee osteoarthritis. The procedure involves harvesting of bone marrow aspirate (BMA) from the posterior superior iliac spine (PSIS) and then following centrifugation in an FDA approved device (EmCyte GenesisCS Pure BMAC®-60 ml) will be injected back into the knee joint. All injections will be made via ultrasound guidance using a standard approach.
BIOLOGICALAdipose-derived MSCs
Adipose-derived Stromal Vascular Fraction (SVF) will be obtained from a mini lipoaspirate. The lipoaspirate will then be enzymatically digested to produce a SVF that will be injected into the knee joint. All injections will be made via ultrasound guidance using a standard approach.
BIOLOGICALUmbilical Cord Tissue (UCT) MSCs
Cryopreserved doses of umbilical cord tissue MSCs will be used. These MSCs were cryopreserved at P2 culture in plasmalyte A + 5% human serum albumin in 5 finger cryobags containing 20 million cells in 4 mL and stored under liquid nitrogen until shipment. Cells will be transported in a dry shipper and thawed at the study sites. The dose of MSCs will be aspirated from the cryobag into a sterile syringe and directly injected into the knee. All injections will be made via ultrasound guidance using a standard approach.
DRUGCorticosteroid injection
The corticosteroid injection is prepared by mixing 1cc of 40mg/dL depomedrol and 6cc of normal saline in a 10cc syringe will be made into the knee joint. All injections will be made via ultrasound guidance using a standard approach.
Sponsors
The Marcus Foundation
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will not know if they are receiving the MSC or corticosteroid injection.
Intervention model description
The study will include a parallel design using a blocked central randomization scheme of 1:1:1:1. Participants will first be randomized to have MSCs derived from either bone marrow, adipose tissue, or umbilical cord tissue. Then they will be further randomized to receive either an injection of MSCs (from bone marrow, adipose, or umbilical cord tissue, depending on the first randomization) or a corticosteroid injection.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age greater or equal to 40 but less than or equal to 70 years old * Males and females * Recent knee radiograph of the targeted knee (standing anteroposterior (AP) lateral and sunrise view) * Diagnosis of OA in the targeted knee (radiographic evidence of OA in the medial and/or lateral tibiofemoral compartment, which would include one or more osteophytes on a standard radiograph taken within 3 months) * Continued OA pain in the targeted knee despite conservative measures (per treating provider's discretion) * Average daily Visual Analog Scale (VAS) ≥3 * Kellgren-Lawrence system of Grade II, III, or IV * Subjects may have concomitant patellofemoral but they must have stage II or higher generalized knee OA * Females of childbearing potential only, must have a negative pregnancy test done at screening prior to enrollment in the study * Women and men of child-producing potential must agree to use acceptable contraception methods for the duration of the trial such as birth control pills or condoms with spermicide
Exclusion criteria
* Clinically apparent tense effusion of the targeted knee * Significant valgus/varus deformities (+/- 10 degrees) * Viscosupplementation within 6 months in the targeted knee * Other biologic injection (PRP or stem cell) within 1 year in the targeted knee * Surgery in the targeted knee within the past 6 months (either open or scope) * Systemic or intra-articular injection of corticosteroids in any joint within 3 months before screening * Daily opioid use for the past three months * History of malignancy in the previous 5 years prior to study entry, with the exception of in-situ cancers treated only by local excision with curative intent * History of, or ongoing, autoimmune disorder that requires treatment with an immunosuppressive medication * Active, suspected, or prior infection to the joint in the targeted knee * Part of a vulnerable population per Office for Human Research Protections (OHRP) definition (pregnant women and breast-feeding women, cognitively impaired, prisoners, etc.) * Unwilling to discontinue the use of Non-Steroidal Anti-Inflammatory (NSAID)s for 7 calendar days prior to the procedure * Unwilling to discontinue use of NSAIDS for 5 calendar days after procedure * History of bleeding disorders or inflammatory joint disease * Inability to hold anti-platelet therapy according to treating provider prior to procedure * Subject is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason * Uncontrolled diabetes * Subject has an active workers' compensation case in progress with targeted knee * Subject with insufficient amount of subcutaneous tissue * Hemoglobin less than 10g/dL at the time of screening * Leukocytes \<3,000/μL; neutrophils \<1,500/μL; lymphocytes \<800/μL; platelets \<100,000/μL at the time of screening * Diagnosis of liver disease as defined by alanine aminotransferase (ALT) \>3x the upper limit of age-determined normal (ULN) or total bilirubin \> 1.5x ULN * Subjects who have had greater than 3 corticosteroid injections in the targeted knee in the 12 months prior to screening or at the physician's discretion * Subjects with a known diagnosis of osteoporosis * Subjects with anticipated use of systemic corticosteroids during the study period for treatment of a chronic medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Pain Scale (VAS-pain) Score | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months | Pain assessment was performed using the Visual Analog Pain Scale (VAS-pain). The VAS-pain is self-completed by the participant. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance in millimeters (mm) on the line between the no pain anchor and the participant's mark, providing a range of scores from 0-100. The recommended cut points for VAS are: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). The change in VAS-pain score is the score from the each follow-up visit subtracted from the baseline score. A negative value means that pain has reduced from what it was at baseline. |
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months | The KOOS questionnaire assesses the participant's opinion about their osteoarthritis and associated problems. It consists of 5 subscales: pain, symptoms, activities of daily living (ADL) function, sport and recreation function, and knee related quality of life (QoL). The pain subscale has 9 items and response options are given on a 5-point Likert scale where 0 = no problems and 4 = extreme problems. Scores are transformed to a scale ranging from 0 to 100 with 0 indicating extreme symptoms and 100 indicating no symptoms. The change in KOOS-pain subscale score is the score from each follow-up visit subtracted from the baseline score. A negative value means that pain has worsened from what it was at baseline, while a positive value means that pain has improved from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months | The KOOS questionnaire assesses the participant's opinion about their osteoarthritis and associated problems. It consists of 5 subscales: pain, symptoms, activities of daily living (ADL) function, sport and recreation function, and knee related quality of life (QoL). The KOOS has 42 items across all subscales and response options are given on a 5-point Likert scale where 0 = no problems and 4 = extreme problems. The sum of subscale scores is transformed to a scale ranging from 0 to 100 with 0 indicating extreme symptoms and 100 indicating no symptoms. A negative value means that pain has worsened from what it was at baseline, while a positive value means that pain has improved from baseline. |
| Change in EuroQuality of Life (EQ-5D-3L) Index Score | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months | The EQ-5D-3L survey measures the severity of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participants will be asked to answer questions regarding these measures and to indicate their current experience on a scale from 1 to 3 (1 being no problem and 3 being most extreme problem). A sixth item asks participants to rate their current heath from 0 (worst imaginable) to 100 (best imaginable). The answers to these questions are converted into an index value based on the country respondents live in. Health state index scores typically range from less than 0 to 1, where 0 is a health state equivalent to death and 1 is perfect health. Positive values for the change from baseline score indicate improved health. |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months | The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales are scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Scores higher than 50 indicate more of the specific scale's construct, which may indicate a desirable or an undesirable outcome. |
| Overall MRI Grade of Osteoarthritis | Baseline, Month 6, Month 12 | An MRI grade of osteoarthritis was calculated by rating features viewed by MRI (such as cartilage loss) in terms of severity and extent. Total scores range from 0 to 69 with higher values indicating more severe osteoarthritis. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Duke University in Durham, North Carolina, Sanford Health in Fargo, North Dakota, The Emory Clinic in Atlanta, Georgia, Sanford Health in Sioux Falls, South Dakota, and the Andrews Institute in Gulf Breeze, Florida, USA. Participant enrollment began March 28, 2019 and all follow-up was complete by May 31, 2022.
Participants by arm
| Arm | Count |
|---|---|
| Bone Marrow Derived MSCs Participants randomized to this arm underwent bone marrow aspiration and then were further randomized to receive a standard orthobiologic injection into the knee joint of autologous bone marrow concentrate (BMAC). | 118 |
| Adipose-derived MSCs Participants randomized to this arm underwent small volume lipoplasty, and then were further randomized to receive an injection into the knee joint of adipose-derived stromal vascular fraction (SVF). | 119 |
| Umbilical Cord Tissue (UCT) MSCs Participants randomized to this arm received an injection into the knee joint of cryopreserved doses of umbilical cord tissue MSCs. | 118 |
| Corticosteroid Injection Participants randomized to the bone marrow derived MSC, adipose-derived MSC, or umbilical cord tissue MSC study arms who were further randomized to the control group and received a corticosteroid (CS) injection into the knee joint. | 120 |
| Total | 475 |
Baseline characteristics
| Characteristic | Adipose-derived MSCs | Umbilical Cord Tissue (UCT) MSCs | Corticosteroid Injection | Bone Marrow Derived MSCs | Total |
|---|---|---|---|---|---|
| Age, Continuous | 58.2 years STANDARD_DEVIATION 7.31 | 57.9 years STANDARD_DEVIATION 8.18 | 58.3 years STANDARD_DEVIATION 8.05 | 58.6 years STANDARD_DEVIATION 7.33 | 58.3 years STANDARD_DEVIATION 7.71 |
| Age, Customized Categorical age 40 to 59 years of age | 63 Participants | 64 Participants | 62 Participants | 57 Participants | 246 Participants |
| Age, Customized Categorical age 60 to 70 years of age | 56 Participants | 54 Participants | 58 Participants | 61 Participants | 229 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 6 Participants | 0 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 113 Participants | 113 Participants | 114 Participants | 116 Participants | 456 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 2 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 11 Participants | 12 Participants | 19 Participants | 57 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 5 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 99 Participants | 102 Participants | 104 Participants | 92 Participants | 397 Participants |
| Region of Enrollment United States | 119 Participants | 118 Participants | 120 Participants | 118 Participants | 475 Participants |
| Sex: Female, Male Female | 63 Participants | 65 Participants | 71 Participants | 62 Participants | 261 Participants |
| Sex: Female, Male Male | 56 Participants | 53 Participants | 49 Participants | 56 Participants | 214 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 / 107 | 0 / 109 | 0 / 116 | 0 / 108 |
| other Total, other adverse events | 53 / 107 | 64 / 109 | 45 / 116 | 48 / 108 |
| serious Total, serious adverse events | 8 / 107 | 2 / 109 | 4 / 116 | 5 / 108 |
Outcome results
Primary
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score
The KOOS questionnaire assesses the participant's opinion about their osteoarthritis and associated problems. It consists of 5 subscales: pain, symptoms, activities of daily living (ADL) function, sport and recreation function, and knee related quality of life (QoL). The pain subscale has 9 items and response options are given on a 5-point Likert scale where 0 = no problems and 4 = extreme problems. Scores are transformed to a scale ranging from 0 to 100 with 0 indicating extreme symptoms and 100 indicating no symptoms. The change in KOOS-pain subscale score is the score from each follow-up visit subtracted from the baseline score. A negative value means that pain has worsened from what it was at baseline, while a positive value means that pain has improved from baseline.
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Population: This analysis includes participants who successfully completed this assessment at the indicated post-baseline study visit. Some participants withdrew from the study prior to study completion and some attended study visits but did not complete each study assessment correctly.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bone Marrow Derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 9 | 16.2 score on a scale | Standard Error 193 |
| Bone Marrow Derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 3 | 19.2 score on a scale | Standard Error 1.86 |
| Bone Marrow Derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 12 | 18.9 score on a scale | Standard Error 1.88 |
| Bone Marrow Derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 6 | 18.1 score on a scale | Standard Error 1.88 |
| Bone Marrow Derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 1 | 15.5 score on a scale | Standard Error 1.85 |
| Adipose-derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 6 | 17.2 score on a scale | Standard Error 1.87 |
| Adipose-derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 9 | 14.7 score on a scale | Standard Error 1.93 |
| Adipose-derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 12 | 17.3 score on a scale | Standard Error 1.88 |
| Adipose-derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 3 | 16.8 score on a scale | Standard Error 1.84 |
| Adipose-derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 1 | 15.4 score on a scale | Standard Error 1.84 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 6 | 15.4 score on a scale | Standard Error 1.81 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 1 | 11.5 score on a scale | Standard Error 1.77 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 3 | 12.8 score on a scale | Standard Error 1.79 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 9 | 13.9 score on a scale | Standard Error 1.88 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 12 | 16.4 score on a scale | Standard Error 1.81 |
| Corticosteroid Injection | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 9 | 16.3 score on a scale | Standard Error 1.92 |
| Corticosteroid Injection | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 3 | 18.7 score on a scale | Standard Error 1.83 |
| Corticosteroid Injection | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 1 | 19.2 score on a scale | Standard Error 1.83 |
| Corticosteroid Injection | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 6 | 18.6 score on a scale | Standard Error 1.85 |
| Corticosteroid Injection | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score | Absolute Change from Baseline at Month 12 | 18.5 score on a scale | Standard Error 1.85 |
Primary
Change in Visual Analog Pain Scale (VAS-pain) Score
Pain assessment was performed using the Visual Analog Pain Scale (VAS-pain). The VAS-pain is self-completed by the participant. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance in millimeters (mm) on the line between the no pain anchor and the participant's mark, providing a range of scores from 0-100. The recommended cut points for VAS are: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). The change in VAS-pain score is the score from the each follow-up visit subtracted from the baseline score. A negative value means that pain has reduced from what it was at baseline.
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Population: This analysis includes participants who successfully completed this assessment at the indicated post-baseline study visit. Some participants withdrew from the study prior to study completion and some attended study visits but did not complete each study assessment correctly.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bone Marrow Derived MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 9 | -21.9 units on a scale | Standard Error 2.64 |
| Bone Marrow Derived MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 3 | -28.8 units on a scale | Standard Error 2.54 |
| Bone Marrow Derived MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 12 | -25.5 units on a scale | Standard Error 2.56 |
| Bone Marrow Derived MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 6 | -23.2 units on a scale | Standard Error 2.56 |
| Bone Marrow Derived MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 1 | -20.2 units on a scale | Standard Error 2.52 |
| Adipose-derived MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 6 | -21.6 units on a scale | Standard Error 2.53 |
| Adipose-derived MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 9 | -17.9 units on a scale | Standard Error 2.63 |
| Adipose-derived MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 12 | -19.9 units on a scale | Standard Error 2.55 |
| Adipose-derived MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 3 | -17.8 units on a scale | Standard Error 2.48 |
| Adipose-derived MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 1 | -15.9 units on a scale | Standard Error 2.48 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 6 | -19.7 units on a scale | Standard Error 2.47 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 1 | -16.7 units on a scale | Standard Error 2.4 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 3 | -17.3 units on a scale | Standard Error 2.43 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 9 | -16.5 units on a scale | Standard Error 2.58 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 12 | -20.6 units on a scale | Standard Error 2.48 |
| Corticosteroid Injection | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 9 | -23.3 units on a scale | Standard Error 2.63 |
| Corticosteroid Injection | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 3 | -21.1 units on a scale | Standard Error 2.49 |
| Corticosteroid Injection | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 1 | -25.2 units on a scale | Standard Error 2.49 |
| Corticosteroid Injection | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 6 | -22.7 units on a scale | Standard Error 2.51 |
| Corticosteroid Injection | Change in Visual Analog Pain Scale (VAS-pain) Score | Absolute Change from Baseline at Month 12 | -22.3 units on a scale | Standard Error 2.51 |
Secondary
Change in EuroQuality of Life (EQ-5D-3L) Index Score
The EQ-5D-3L survey measures the severity of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participants will be asked to answer questions regarding these measures and to indicate their current experience on a scale from 1 to 3 (1 being no problem and 3 being most extreme problem). A sixth item asks participants to rate their current heath from 0 (worst imaginable) to 100 (best imaginable). The answers to these questions are converted into an index value based on the country respondents live in. Health state index scores typically range from less than 0 to 1, where 0 is a health state equivalent to death and 1 is perfect health. Positive values for the change from baseline score indicate improved health.
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Population: This analysis includes participants who successfully completed this assessment at the indicated post-baseline study visit. Some participants withdrew from the study prior to study completion and some attended study visits but did not complete each study assessment correctly.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bone Marrow Derived MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 9 | 0.0 score on a scale | Standard Error 0.02 |
| Bone Marrow Derived MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 3 | 0.1 score on a scale | Standard Error 0.01 |
| Bone Marrow Derived MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 12 | 0.1 score on a scale | Standard Error 0.01 |
| Bone Marrow Derived MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 6 | 0.1 score on a scale | Standard Error 0.01 |
| Bone Marrow Derived MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 1 | 0.1 score on a scale | Standard Error 0.01 |
| Adipose-derived MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 6 | 0.1 score on a scale | Standard Error 0.01 |
| Adipose-derived MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 9 | 0.1 score on a scale | Standard Error 0.02 |
| Adipose-derived MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 12 | 0.1 score on a scale | Standard Error 0.01 |
| Adipose-derived MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 3 | 0.1 score on a scale | Standard Error 0.01 |
| Adipose-derived MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 1 | 0.1 score on a scale | Standard Error 0.01 |
| Umbilical Cord Tissue (UCT) MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 6 | 0.1 score on a scale | Standard Error 0.01 |
| Umbilical Cord Tissue (UCT) MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 1 | 0.1 score on a scale | Standard Error 0.01 |
| Umbilical Cord Tissue (UCT) MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 3 | 0.1 score on a scale | Standard Error 0.01 |
| Umbilical Cord Tissue (UCT) MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 9 | 0.1 score on a scale | Standard Error 0.02 |
| Umbilical Cord Tissue (UCT) MSCs | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 12 | 0.1 score on a scale | Standard Error 0.01 |
| Corticosteroid Injection | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 9 | 0.1 score on a scale | Standard Error 0.02 |
| Corticosteroid Injection | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 3 | 0.1 score on a scale | Standard Error 0.01 |
| Corticosteroid Injection | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 1 | 0.1 score on a scale | Standard Error 0.01 |
| Corticosteroid Injection | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 6 | 0.1 score on a scale | Standard Error 0.01 |
| Corticosteroid Injection | Change in EuroQuality of Life (EQ-5D-3L) Index Score | Absolute Change from Baseline at Month 12 | 0.1 score on a scale | Standard Error 0.01 |
Secondary
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score
The KOOS questionnaire assesses the participant's opinion about their osteoarthritis and associated problems. It consists of 5 subscales: pain, symptoms, activities of daily living (ADL) function, sport and recreation function, and knee related quality of life (QoL). The KOOS has 42 items across all subscales and response options are given on a 5-point Likert scale where 0 = no problems and 4 = extreme problems. The sum of subscale scores is transformed to a scale ranging from 0 to 100 with 0 indicating extreme symptoms and 100 indicating no symptoms. A negative value means that pain has worsened from what it was at baseline, while a positive value means that pain has improved from baseline.
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Population: This analysis includes participants who successfully completed this assessment at the indicated post-baseline study visit. Some participants withdrew from the study prior to study completion and some attended study visits but did not complete each study assessment correctly. This analysis includes participants who had complete information for each subscale of the KOOS questionnaire, allowing for calculation of the total KOOS score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone Marrow Derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 9 | 14.17 score on a scale | Standard Deviation 18.87 |
| Bone Marrow Derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 3 | 18.63 score on a scale | Standard Deviation 15.32 |
| Bone Marrow Derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 12 | 18.52 score on a scale | Standard Deviation 18.93 |
| Bone Marrow Derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 6 | 18.39 score on a scale | Standard Deviation 16.96 |
| Bone Marrow Derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 1 | 14.48 score on a scale | Standard Deviation 14.95 |
| Adipose-derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 6 | 17.53 score on a scale | Standard Deviation 16.23 |
| Adipose-derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 9 | 13.36 score on a scale | Standard Deviation 16.91 |
| Adipose-derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 12 | 17.61 score on a scale | Standard Deviation 19.7 |
| Adipose-derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 3 | 16.30 score on a scale | Standard Deviation 16.02 |
| Adipose-derived MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 1 | 14.34 score on a scale | Standard Deviation 12.4 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 6 | 15.62 score on a scale | Standard Deviation 14.66 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 1 | 11.14 score on a scale | Standard Deviation 12.47 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 3 | 13.85 score on a scale | Standard Deviation 14.36 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 9 | 13.96 score on a scale | Standard Deviation 15.83 |
| Umbilical Cord Tissue (UCT) MSCs | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 12 | 17.49 score on a scale | Standard Deviation 18.34 |
| Corticosteroid Injection | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 9 | 116.30 score on a scale | Standard Deviation 18.54 |
| Corticosteroid Injection | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 3 | 17.21 score on a scale | Standard Deviation 16.97 |
| Corticosteroid Injection | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 1 | 17.70 score on a scale | Standard Deviation 14.65 |
| Corticosteroid Injection | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 6 | 17.44 score on a scale | Standard Deviation 17.47 |
| Corticosteroid Injection | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score | Change from Baseline at Month 12 | 19.27 score on a scale | Standard Deviation 18.54 |
Secondary
Overall MRI Grade of Osteoarthritis
An MRI grade of osteoarthritis was calculated by rating features viewed by MRI (such as cartilage loss) in terms of severity and extent. Total scores range from 0 to 69 with higher values indicating more severe osteoarthritis.
Time frame: Baseline, Month 6, Month 12
Population: This analysis includes participants who successfully completed the MRI assessment at the indicated study visit. Some participants withdrew from the study prior to reaching study visits where the MRI was conducted. Some participants who attended the MRI visit were not able to hold still during the entire MRI and an accurate measurement could not be obtained.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone Marrow Derived MSCs | Overall MRI Grade of Osteoarthritis | Month 6 | 40.4 score on a scale | Standard Deviation 6.27 |
| Bone Marrow Derived MSCs | Overall MRI Grade of Osteoarthritis | Baseline | 40.5 score on a scale | Standard Deviation 6.19 |
| Bone Marrow Derived MSCs | Overall MRI Grade of Osteoarthritis | Month 12 | 40.8 score on a scale | Standard Deviation 6.01 |
| Adipose-derived MSCs | Overall MRI Grade of Osteoarthritis | Month 6 | 39.3 score on a scale | Standard Deviation 7.55 |
| Adipose-derived MSCs | Overall MRI Grade of Osteoarthritis | Baseline | 39.7 score on a scale | Standard Deviation 7.82 |
| Adipose-derived MSCs | Overall MRI Grade of Osteoarthritis | Month 12 | 39.8 score on a scale | Standard Deviation 7.76 |
| Umbilical Cord Tissue (UCT) MSCs | Overall MRI Grade of Osteoarthritis | Month 6 | 38.3 score on a scale | Standard Deviation 7.86 |
| Umbilical Cord Tissue (UCT) MSCs | Overall MRI Grade of Osteoarthritis | Baseline | 38.2 score on a scale | Standard Deviation 7.77 |
| Umbilical Cord Tissue (UCT) MSCs | Overall MRI Grade of Osteoarthritis | Month 12 | 37.6 score on a scale | Standard Deviation 7.81 |
| Corticosteroid Injection | Overall MRI Grade of Osteoarthritis | Baseline | 38.9 score on a scale | Standard Deviation 7.7 |
| Corticosteroid Injection | Overall MRI Grade of Osteoarthritis | Month 12 | 39.0 score on a scale | Standard Deviation 7.84 |
| Corticosteroid Injection | Overall MRI Grade of Osteoarthritis | Month 6 | 39.3 score on a scale | Standard Deviation 7.88 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score
The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales are scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Scores higher than 50 indicate more of the specific scale's construct, which may indicate a desirable or an undesirable outcome.
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Population: This analysis includes participants who successfully completed this assessment at the indicated post-baseline study visit. Some participants withdrew from the study prior to study completion and some attended study visits but did not complete each study assessment correctly. Participants with incomplete responses are not included in the analysis for that domain.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 6 | 51.5 t-score | Standard Deviation 8.8 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 3 | 51.6 t-score | Standard Deviation 8.17 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 12 | 44.5 t-score | Standard Deviation 6.33 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Baseline | 49.5 t-score | Standard Deviation 8.24 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 1 | 53.6 t-score | Standard Deviation 7.76 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Baseline | 59.1 t-score | Standard Deviation 6.06 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Baseline | 46.8 t-score | Standard Deviation 8.35 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 6 | 45.9 t-score | Standard Deviation 7.45 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 12 | 45.6 t-score | Standard Deviation 9.09 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 9 | 46.7 t-score | Standard Deviation 9.39 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 1 | 45.8 t-score | Standard Deviation 8.94 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 1 | 45.9 t-score | Standard Deviation 7.46 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 6 | 45.9 t-score | Standard Deviation 9.52 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 3 | 45.0 t-score | Standard Deviation 9.35 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 12 | 47.8 t-score | Standard Deviation 8.42 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 9 | 48.9 t-score | Standard Deviation 7.5 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 9 | 46.1 t-score | Standard Deviation 8.04 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 12 | 53.3 t-score | Standard Deviation 9.02 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 6 | 48.6 t-score | Standard Deviation 8.31 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 3 | 47.3 t-score | Standard Deviation 7.94 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 12 | 45.6 t-score | Standard Deviation 8.1 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Baseline | 47.1 t-score | Standard Deviation 7.89 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 1 | 47.2 t-score | Standard Deviation 7.48 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 6 | 53.1 t-score | Standard Deviation 8.77 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Baseline | 48.9 t-score | Standard Deviation 7 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Baseline | 44.7 t-score | Standard Deviation 5.7 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 3 | 54.4 t-score | Standard Deviation 9.36 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 12 | 44.4 t-score | Standard Deviation 7.81 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 9 | 43.0 t-score | Standard Deviation 7.32 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 1 | 44.3 t-score | Standard Deviation 6.54 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 3 | 45.1 t-score | Standard Deviation 7.34 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 6 | 44.5 t-score | Standard Deviation 7.33 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 3 | 44.9 t-score | Standard Deviation 7.77 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 3 | 43.8 t-score | Standard Deviation 5.56 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 1 | 43.0 t-score | Standard Deviation 7.3 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Baseline | 39.3 t-score | Standard Deviation 5.3 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 6 | 43.9 t-score | Standard Deviation 5.98 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 9 | 53.6 t-score | Standard Deviation 9.02 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 12 | 51.5 t-score | Standard Deviation 8.47 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 9 | 52.4 t-score | Standard Deviation 8.55 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 9 | 45.6 t-score | Standard Deviation 6.99 |
| Bone Marrow Derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 1 | 52.1 t-score | Standard Deviation 8.69 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 12 | 45.3 t-score | Standard Deviation 7.46 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Baseline | 47.5 t-score | Standard Deviation 7.79 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 1 | 45.4 t-score | Standard Deviation 7.64 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 3 | 45.4 t-score | Standard Deviation 7.91 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 6 | 45.8 t-score | Standard Deviation 8.23 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 9 | 45.4 t-score | Standard Deviation 7.94 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 3 | 44.0 t-score | Standard Deviation 6.46 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Baseline | 45.0 t-score | Standard Deviation 6.56 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 1 | 43.8 t-score | Standard Deviation 6.19 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 6 | 44.9 t-score | Standard Deviation 6.5 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 9 | 45.2 t-score | Standard Deviation 6.71 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 12 | 43.9 t-score | Standard Deviation 6.01 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Baseline | 47.0 t-score | Standard Deviation 8.29 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 1 | 45.8 t-score | Standard Deviation 8.96 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 3 | 45.3 t-score | Standard Deviation 8.5 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 6 | 46.1 t-score | Standard Deviation 8.77 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 9 | 46.1 t-score | Standard Deviation 8.98 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 12 | 45.2 t-score | Standard Deviation 8.26 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Baseline | 58.6 t-score | Standard Deviation 6.72 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 1 | 52.5 t-score | Standard Deviation 6.82 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 3 | 52.1 t-score | Standard Deviation 7.42 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 6 | 51.5 t-score | Standard Deviation 8 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 9 | 52.3 t-score | Standard Deviation 8.21 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 12 | 50.8 t-score | Standard Deviation 8.23 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Baseline | 40.3 t-score | Standard Deviation 5.8 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 1 | 43.6 t-score | Standard Deviation 5.48 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 3 | 44.3 t-score | Standard Deviation 5.84 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 6 | 45.2 t-score | Standard Deviation 6.72 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 9 | 44.6 t-score | Standard Deviation 6.6 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 12 | 45.2 t-score | Standard Deviation 7.2 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Baseline | 49.7 t-score | Standard Deviation 7.74 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 1 | 48.4 t-score | Standard Deviation 7.63 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 3 | 48.3 t-score | Standard Deviation 7.85 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 6 | 48.9 t-score | Standard Deviation 6.88 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 9 | 48.5 t-score | Standard Deviation 7.35 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 12 | 49.0 t-score | Standard Deviation 7.02 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Baseline | 47.9 t-score | Standard Deviation 8.33 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 1 | 51.6 t-score | Standard Deviation 7.83 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 3 | 53.3 t-score | Standard Deviation 8.18 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 6 | 52.7 t-score | Standard Deviation 8.32 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 9 | 52.6 t-score | Standard Deviation 8.41 |
| Adipose-derived MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 12 | 53.5 t-score | Standard Deviation 8.51 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 9 | 43.4 t-score | Standard Deviation 5.03 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 6 | 51.9 t-score | Standard Deviation 7.71 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 3 | 45.4 t-score | Standard Deviation 7.15 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 9 | 51.8 t-score | Standard Deviation 8.14 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 6 | 44.0 t-score | Standard Deviation 5.44 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 12 | 51.2 t-score | Standard Deviation 8.26 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 1 | 51.0 t-score | Standard Deviation 7.65 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Baseline | 38.8 t-score | Standard Deviation 4.04 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 3 | 44.4 t-score | Standard Deviation 5.88 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 1 | 41.9 t-score | Standard Deviation 6.07 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 3 | 43.8 t-score | Standard Deviation 6.81 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 1 | 44.9 t-score | Standard Deviation 5.97 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Baseline | 47.1 t-score | Standard Deviation 7.31 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 6 | 44.2 t-score | Standard Deviation 6.59 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 3 | 52.4 t-score | Standard Deviation 8.25 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 9 | 44.4 t-score | Standard Deviation 7.17 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Baseline | 44.9 t-score | Standard Deviation 6.34 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 12 | 44.8 t-score | Standard Deviation 7.25 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 1 | 45.9 t-score | Standard Deviation 7.73 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Baseline | 50.1 t-score | Standard Deviation 7.92 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 12 | 44.9 t-score | Standard Deviation 7.25 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 1 | 48.3 t-score | Standard Deviation 8.66 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 6 | 52.3 t-score | Standard Deviation 8.15 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 3 | 47.8 t-score | Standard Deviation 7.9 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 9 | 44.9 t-score | Standard Deviation 6.53 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 6 | 48.1 t-score | Standard Deviation 7.89 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 9 | 48.9 t-score | Standard Deviation 7.77 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 6 | 45.2 t-score | Standard Deviation 7.51 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 3 | 46.0 t-score | Standard Deviation 7.86 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 1 | 46.9 t-score | Standard Deviation 8.45 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 12 | 53.6 t-score | Standard Deviation 8.05 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 6 | 44.9 t-score | Standard Deviation 8.57 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 12 | 48.7 t-score | Standard Deviation 8.05 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 9 | 47.1 t-score | Standard Deviation 8.35 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Baseline | 47.7 t-score | Standard Deviation 7.39 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 12 | 45.9 t-score | Standard Deviation 8.66 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Baseline | 58.9 t-score | Standard Deviation 5.58 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 12 | 44.3 t-score | Standard Deviation 6.05 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 9 | 52.8 t-score | Standard Deviation 8.33 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 1 | 54.8 t-score | Standard Deviation 7.98 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Baseline | 48.2 t-score | Standard Deviation 7.18 |
| Umbilical Cord Tissue (UCT) MSCs | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 3 | 52.5 t-score | Standard Deviation 7.86 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 6 | 45.1 t-score | Standard Deviation 8.3 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Baseline | 46.9 t-score | Standard Deviation 7.53 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 1 | 49.2 t-score | Standard Deviation 7.91 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 6 | 53.6 t-score | Standard Deviation 7.67 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 6 | 44.0 t-score | Standard Deviation 5.38 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 9 | 45.1 t-score | Standard Deviation 6.88 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Baseline | 48.5 t-score | Standard Deviation 8.92 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 9 | 53.2 t-score | Standard Deviation 8.77 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 3 | 53.5 t-score | Standard Deviation 8.72 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 9 | 52.4 t-score | Standard Deviation 8.47 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 3 | 47.9 t-score | Standard Deviation 8.18 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 12 | 52.7 t-score | Standard Deviation 8.48 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 3 | 446 t-score | Standard Deviation 6.6 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Baseline | 60.4 t-score | Standard Deviation 6.56 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 6 | 52.0 t-score | Standard Deviation 8.56 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Baseline | 38.3 t-score | Standard Deviation 5.1 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 9 | 46.8 t-score | Standard Deviation 9.7 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 1 | 51.5 t-score | Standard Deviation 8.3 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 6 | 48.9 t-score | Standard Deviation 7.38 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 1 | 43.3 t-score | Standard Deviation 6.12 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 1 | 45.0 t-score | Standard Deviation 6.92 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 1 | 45.4 t-score | Standard Deviation 7.83 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 6 | 45.3 t-score | Standard Deviation 6.66 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 3 | 42.9 t-score | Standard Deviation 7.03 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Baseline | 48.2 t-score | Standard Deviation 8.69 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Pain Score - Month 1 | 53.3 t-score | Standard Deviation 7.81 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 9 | 47.9 t-score | Standard Deviation 8.17 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 6 | 43.0 t-score | Standard Deviation 6.15 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Baseline | 45.6 t-score | Standard Deviation 7.61 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 1 | 46.2 t-score | Standard Deviation 8.55 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Month 12 | 48.8 t-score | Standard Deviation 8.08 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 9 | 43.0 t-score | Standard Deviation 6.76 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 9 | 44.1 t-score | Standard Deviation 5.78 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 3 | 51.6 t-score | Standard Deviation 9 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 3 | 44.8 t-score | Standard Deviation 8.5 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Physical Function Score - Month 12 | 43.6 t-score | Standard Deviation 6.84 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 12 | 45.2 t-score | Standard Deviation 8.09 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Fatigue Score - Month 12 | 45.3 t-score | Standard Deviation 9.84 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Depression Score - Month 12 | 44.5 t-score | Standard Deviation 6.65 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Sleep Disturbance Score - Baseline | 50.2 t-score | Standard Deviation 8.07 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Anxiety Score - Month 3 | 45.5 t-score | Standard Deviation 7.67 |
| Corticosteroid Injection | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score | Social Roles and Activities Score - Month 12 | 52.2 t-score | Standard Deviation 8.3 |