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| Name | Class |
|---|---|
| The Marcus Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone Marrow Derived MSCs | Experimental | Participants randomized to this arm will undergo bone marrow aspiration and then will be further randomized to receive a standard orthobiologic injection into the knee joint of autologous bone marrow concentrate (BMAC). |
|
| Adipose-derived MSCs | Experimental | Participants randomized to this arm will undergo small volume lipoplasty, and then will be further randomized to receive an injection into the knee joint of adipose-derived stromal vascular fraction (SVF). |
|
| Umbilical Cord Tissue (UCT) MSCs | Experimental | Participants randomized to this arm will receive an injection into the knee joint of cryopreserved doses of umbilical cord tissue MSCs. |
|
| Corticosteroid Injection | Active Comparator | Participants randomized to the bone marrow derived MSC, adipose-derived MSC, or umbilical cord tissue MSC study arms will be further randomized within the arm in a 3:1 ratio to receive either MSCs derived from the study arm of the initial randomization or a corticosteroid (CS) injection. Participants randomized to the control group will receive an injection of corticosteroid into the knee joint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow Derived MSCs | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months |
| 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. | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hicham Drissi, PhD | Emory University | Study Director |
| Scott D Boden, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andrews Institute | Gulf Breeze | Florida | 32561 | United States | ||
| The Emory Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41014273 | Derived | Mautner K, Kaiser JM, Boggess B, Hackel J, Kurtenbach C, Noonan B, Shenvi N, Easley KA, Myer GD, Jayaram P, Gottschalk M, Boden S, Drissi H. Autologous Cell Injections for Knee Osteoarthritis Display Greater Responsiveness Than Allogenic Cellular Products and Corticosteroids in a Sex-Dependent Manner. Am J Sports Med. 2025 Oct;53(12):2889-2897. doi: 10.1177/03635465251365521. Epub 2025 Sep 27. | |
| 37919438 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bone Marrow Derived Mesenchymal Stem Cells (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). |
| FG001 | 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). |
| FG002 | 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. |
| FG003 | Corticosteroid Injection | Participants randomized to the bone marrow derived MSCs, adipose-derived MSCs, or umbilical cord tissue MSCs study arms who were further randomized to the control group and received a corticosteroid (CS) injection into the knee joint. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Adipose-derived MSCs |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months |
Information on adverse events was collected from the time participants began receiving the study intervention until the Month 12 follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metastatic breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Mautner, MD | Emory University | 404-778-7142 | kmautne@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2020 | May 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D000077555 | Methylprednisolone Acetate |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
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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.
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Participants will not know if they are receiving the MSC or corticosteroid injection.
|
| Adipose-derived MSCs | Biological | 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. |
|
| Umbilical Cord Tissue (UCT) MSCs | Biological | 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. |
|
| Corticosteroid injection | Drug | 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. |
|
|
| Baseline, 1 month, 3 months, 6 months, 9 months, 12 months |
| 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. | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months |
| 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. | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months |
| 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. | Baseline, Month 6, Month 12 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Sanford Health | Fargo | North Dakota | 58103 | United States |
| Sanford Health | Sioux Falls | South Dakota | 57104 | United States |
| Derived |
| Mautner K, Gottschalk M, Boden SD, Akard A, Bae WC, Black L, Boggess B, Chatterjee P, Chung CB, Easley KA, Gibson G, Hackel J, Jensen K, Kippner L, Kurtenbach C, Kurtzberg J, Mason RA, Noonan B, Roy K, Valentine V, Yeago C, Drissi H. Cell-based versus corticosteroid injections for knee pain in osteoarthritis: a randomized phase 3 trial. Nat Med. 2023 Dec;29(12):3120-3126. doi: 10.1038/s41591-023-02632-w. Epub 2023 Nov 2. |
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). |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | 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). |
| OG001 | 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). |
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | t-score | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6, Month 12 |
|
|
|
| 0 |
| 107 |
| 8 |
| 107 |
| 53 |
| 107 |
| EG001 | 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). | 0 | 109 | 2 | 109 | 64 | 109 |
| EG002 | 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. | 0 | 116 | 4 | 116 | 45 | 116 |
| EG003 | 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. | 0 | 108 | 5 | 108 | 48 | 108 |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Angina pectoris | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Atrial fibrillation | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | Non-systematic Assessment |
|
| Abdominal abscess | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Traumatic pneumothorax | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ischemic stroke | Nervous system disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Partial seizures | Nervous system disorders | Non-systematic Assessment |
|
| Radiculopathy | Nervous system disorders | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Hypertension urgency | Vascular disorders | Non-systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Post procedural contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
Not provided
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| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
|
|
|
|
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| Absolute Change from Baseline at Month 3 |
|
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| Absolute Change from Baseline at Month 6 |
|
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| Absolute Change from Baseline at Month 9 |
|
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| Absolute Change from Baseline at Month 12 |
|
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| Change from Baseline at Month 3 |
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| Change from Baseline at Month 6 |
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| Change from Baseline at Month 9 |
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| Change from Baseline at Month 12 |
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| Absolute Change from Baseline at Month 3 |
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| Absolute Change from Baseline at Month 6 |
|
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| Absolute Change from Baseline at Month 9 |
|
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| Absolute Change from Baseline at Month 12 |
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| Anxiety Score - Month 1 |
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| Anxiety Score - Month 3 |
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| Anxiety Score - Month 6 |
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| Anxiety Score - Month 9 |
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| Anxiety Score - Month 12 |
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| Depression Score - Baseline |
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| Depression Score - Month 1 |
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| Depression Score - Month 3 |
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| Depression Score - Month 6 |
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| Depression Score - Month 9 |
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| Depression Score - Month 12 |
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| Fatigue Score - Baseline |
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| Fatigue Score - Month 1 |
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| Fatigue Score - Month 3 |
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| Fatigue Score - Month 6 |
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| Fatigue Score - Month 9 |
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| Fatigue Score - Month 12 |
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| Pain Score - Baseline |
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| Pain Score - Month 1 |
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| Pain Score - Month 3 |
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| Pain Score - Month 6 |
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| Pain Score - Month 9 |
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| Pain Score - Month 12 |
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| Physical Function Score - Baseline |
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| Physical Function Score - Month 1 |
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| Physical Function Score - Month 3 |
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| Physical Function Score - Month 6 |
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| Physical Function Score - Month 9 |
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| Physical Function Score - Month 12 |
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| Sleep Disturbance Score - Baseline |
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| Sleep Disturbance Score - Month 1 |
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| Sleep Disturbance Score - Month 3 |
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| Sleep Disturbance Score - Month 6 |
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| Sleep Disturbance Score - Month 9 |
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| Sleep Disturbance Score - Month 12 |
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| Social Roles and Activities Score - Baseline |
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| Social Roles and Activities Score - Month 1 |
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| Social Roles and Activities Score - Month 3 |
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| Social Roles and Activities Score - Month 6 |
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| Social Roles and Activities Score - Month 9 |
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| Social Roles and Activities Score - Month 12 |
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| Month 6 |
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| Month 12 |
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