Osteoarthritis, Knee
Conditions
Brief summary
This study is a double-blind, randomized, controlled study with two arms to evaluate JointStem as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 30 subjects will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 positive control). After each subject completes 6-month visit (Visit 6) and the data management team confirms all data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.Only subjects who are assigned will be requested to visit the study center for 9-month and 12-month follow-up visits (Visits 7 and 8). To see long-term effects of JointStem, all subjects who complete Visit 6 will be requested to visit the study center at 24-month after the injection.
Interventions
DRUGJointStem
DRUGSynvisc-One
Sponsors
KCRN Research, LLC
Nature Cell Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Subject who can give written informed consent * Male or female of any race, aged 22-60 * Subject who had osteoarthritis of knee diagnosed at least six months prior to Screening * Subject who has joint pain ≥ 40mm on VAS (Visual Analog Scale) at Screening * Subject who has swelling, tenderness and active range of motion ≥ Grade I at Screening * Subject who seeks invasive interventions of intra-articular injections * Subject who is willing to discontinue all pain medications for osteoarthritis except rescue medication (\< acetaminophen 3.25 g per day) at least 72 hours prior to screening and throughout the duration of study * Subject who has radiographic evidence of grade 3 to 4 osteoarthritis based on the Kellgren and Lawrence radiographic criteria. * Female subject who is neither pregnant nor lactating * Subject who is able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion criteria
* Subject who has Body Mass Index (BMI) \> 35 kg/m2 * Subject who has unstable knees * Subject who took any NSAID within two weeks from Screening * Subject who had any intra-articular injection therapy in any joint within 2 months from Screening * Subject who has any clinically significant disease, which is judged by the investigator to affect this clinical trial * Subject who has inflammatory arthropathy (rheumatoid, psoriatic, or avascular necrosis), and post traumatic or septic arthritis * Subject who has chondrocalcinosis, Paget's disease, Villonodular synovitis, and other non-OA joint diseases * Subject who has HIV/viral hepatitis * Subject who had knee surgery or radiation therapy in the affected joint within 6 months from Screening * Subject who had CVA attack within 6 months from Screening * Subject for whom the investigator judges the liposuction can cause any problem * Subject who has significant lab abnormalities * Subject who has history of local anesthetic allergy * Subject who took immunosuppressants such as Cyclosporin A or azathioprine within 6 weeks from Screening * (If a subject uses aspirin or plavix) Subject for whom it is determined that it would not be safe to stop the aspirin/plavix therapy for 2 weeks prior to Visit 2 * Subject who uses anticoagulants which cannot be stopped or corrected * Subject who had oral or intra-muscular corticosteroids within 30 days from Visit 2 * Subject who had intra-articular corticosteroid injection in any joint within 30 days from Visit 2 * Subject who had intra-articular hyaluronic acid injection within 30 days from Visit 2 * Subject who has known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations or gram positive proteins * Subject who has knee joint infections or skin diseases or infections in the area of the injection site * Subject who has known systemic bleeding disorders * Subject who is an active drug/EtOH abuser * Subject who was enrolled in any other clinical trials within 2 months from Screening * Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above * Subject whose MRI scan results at screening do not demonstrate any sign of cartilage damage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score in JointStem Group | Baseline and 6 months | Comparing the baseline and 6-month WOMAC scores in JointStem group Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment |
| Change From Baseline on Visual Analog Scale (VAS) in JointStem Group | Baseline and 6 months | Comparing the baseline and 6-month VAS scores in JointStem group Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain. |
| MRI Improvement Evaluation in JointStem Group | 6 months | Comparing the baseline and 6-month MRI improvement values in JointStem group MRI Improvement Evaluation was conducted by an MRI analysis company called 'Qmetrics'. The main radiological features evaluated were bone marrow edema, osteophytes, and cartilage. Certain features, such as the appearance of a new cartilage defect or increase in the size of existing cartilage defects or osteophytes, is generally considered an indication of osteoarthritic progression. Similarly, the diminishing in severity or size of existing abnormalities would generally be considered to be a healing(improving) response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on Lysholm Knee Scoring Scale Between JointStem and Positive Control Groups | Baseline and 6 months | Comparing the changes of Lysholm Knee Scoring Scales between JointStem and positive control groups at 6 months Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment |
| Change From Baseline on International Knee Documentation Committee (IKDC) Between JointStem and Positive Control Groups | Baseline and 6 months | Comparing the changes of IKDC scores between JointStem and positive control groups at 6 months IKDC score = {(sum of each item score) / 87} \* 100 Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment |
| Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Baseline and 6 months | Comparing the changes of RAND-36 scores between JointStem and positive control groups at 6 months Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment |
| Change From Baseline on WOMAC in JointStem Group | Baseline, 9 months and 12 months | Comparing the baseline and 9-month/12-month WOMAC scores in JointStem group Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment |
| Change From Baseline on VAS in JointStem Group | Baseline, 9 months and 12 months | Comparing the baseline and 9-month/12-month VAS scores in JointStem group Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain. |
| Change From Baseline on WOMAC Between JointStem and Positive Control Groups | Baseline and 6 months | Comparing the changes of WOMAC scores between JointStem and positive control groups at 6 months Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment |
| Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12 | Baseline, 6 months, 9 months and 12 months | Comparing the baseline and 6-month/9-month/12-month Lysholm Knee Scoring Scale in JointStem group Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment |
| Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | baseline, 6 month, 9 month, 12 month | Comparing the baseline and 6-month/9-month/12-month KOOS scores in JointStem group KOOS score = 100 - \[{(average score of each item) \* 100} / 4 \] Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment |
| Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group | baseline, 6 month, 9 month, 12 month | Comparing the baseline and 6-month/9-month/12-month IKDC scores in JointStem group IKDC score = {(sum of each item score) / 87} \* 100 Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment |
| Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | baseline, 6 month, 9 month, 12 month | Comparing the baseline and 6-month/9-month/12-month RAND-36 scores in JointStem group Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment |
| Comparison of MRI Improvement Evaluation in JointStem Group | Baseline, 6 months and 12 months | Comparing the baseline and 9-month/12-month MRI improvement values in JointStem group MRI Improvement Evaluation was conducted by an MRI analysis company called 'Qmetrics'. The main radiological features evaluated were bone marrow edema, osteophytes, and cartilage. Certain features, such as the appearance of a new cartilage defect or increase in the size of existing cartilage defects or osteophytes, is generally considered an indication of osteoarthritic progression. Similarly, the diminishing in severity or size of existing abnormalities would generally be considered to be a healing(improving) response. |
| Change From Baseline on VAS Between JointStem and Positive Control Groups | Baseline and 6 months | Comparing the changes of VAS scores between JointStem and positive control groups at 6 months Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain. |
| Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups | Baseline and 6 months | Comparing the changes of KOOS values between JointStem and positive control groups at 6 months KOOS score = 100 - \[{(average score of each item) \* 100} / 4 \] Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| JointStem autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem | 19 |
| Synvisc-One hyaluronic acid
Synvisc-One | 9 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | JointStem | Total | Synvisc-One |
|---|---|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 6.98 | 52.3 years STANDARD_DEVIATION 7.72 | 52.1 years STANDARD_DEVIATION 9.56 |
| BMI | 26.903 kg/m^2 STANDARD_DEVIATION 4.1938 | 26.154 kg/m^2 STANDARD_DEVIATION 4.3971 | 24.572 kg/m^2 STANDARD_DEVIATION 4.6408 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 26 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 173.66 cm STANDARD_DEVIATION 9.222 | 172.31 cm STANDARD_DEVIATION 9.527 | 169.46 cm STANDARD_DEVIATION 10.073 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 23 Participants | 7 Participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 2 Participants |
| Sex: Female, Male Male | 11 Participants | 18 Participants | 7 Participants |
| Weight | 81.31 kg STANDARD_DEVIATION 14.642 | 78.2 kg STANDARD_DEVIATION 17.01 | 71.66 kg STANDARD_DEVIATION 20.569 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 9 |
| other Total, other adverse events | 18 / 19 | 4 / 9 |
| serious Total, serious adverse events | 0 / 19 | 0 / 9 |
Outcome results
Primary
Change From Baseline on Visual Analog Scale (VAS) in JointStem Group
Comparing the baseline and 6-month VAS scores in JointStem group Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain.
Time frame: Baseline and 6 months
Population: The primary endpoints were evaluated only in the JointsStem group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JointStem | Change From Baseline on Visual Analog Scale (VAS) in JointStem Group | -32.5 score on a scale | Standard Deviation 23.93 |
Primary
Change From Baseline on Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score in JointStem Group
Comparing the baseline and 6-month WOMAC scores in JointStem group Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment
Time frame: Baseline and 6 months
Population: The primary endpoints were evaluated only in the JointsStem group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JointStem | Change From Baseline on Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score in JointStem Group | -20.121 score on a scale | Standard Deviation 21.0415 |
Primary
MRI Improvement Evaluation in JointStem Group
Comparing the baseline and 6-month MRI improvement values in JointStem group MRI Improvement Evaluation was conducted by an MRI analysis company called 'Qmetrics'. The main radiological features evaluated were bone marrow edema, osteophytes, and cartilage. Certain features, such as the appearance of a new cartilage defect or increase in the size of existing cartilage defects or osteophytes, is generally considered an indication of osteoarthritic progression. Similarly, the diminishing in severity or size of existing abnormalities would generally be considered to be a healing(improving) response.
Time frame: 6 months
Population: The primary endpoints were evaluated only in the JointsStem group. And one patient was excluded from the table due to absence of MRI values.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JointStem | MRI Improvement Evaluation in JointStem Group | Improvement | 5 Participants |
| JointStem | MRI Improvement Evaluation in JointStem Group | No Change | 5 Participants |
| JointStem | MRI Improvement Evaluation in JointStem Group | Progress | 8 Participants |
| Synvisc-One | MRI Improvement Evaluation in JointStem Group | Improvement | 0 Participants |
| Synvisc-One | MRI Improvement Evaluation in JointStem Group | No Change | 0 Participants |
| Synvisc-One | MRI Improvement Evaluation in JointStem Group | Progress | 0 Participants |
Secondary
Change From Baseline on International Knee Documentation Committee (IKDC) Between JointStem and Positive Control Groups
Comparing the changes of IKDC scores between JointStem and positive control groups at 6 months IKDC score = {(sum of each item score) / 87} \* 100 Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time frame: Baseline and 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| JointStem | Change From Baseline on International Knee Documentation Committee (IKDC) Between JointStem and Positive Control Groups | 55.74 score on a scale | Standard Error 2.223 |
| Synvisc-One | Change From Baseline on International Knee Documentation Committee (IKDC) Between JointStem and Positive Control Groups | 54.24 score on a scale | Standard Error 3.238 |
Secondary
Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups
Comparing the changes of KOOS values between JointStem and positive control groups at 6 months KOOS score = 100 - \[{(average score of each item) \* 100} / 4 \] Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| JointStem | Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups | Pain | 21.40 score on a scale | Standard Error 3.975 |
| JointStem | Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups | Sport/Rec | 25.00 score on a scale | Standard Error 5.123 |
| JointStem | Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups | ADL | 18.53 score on a scale | Standard Error 3.937 |
| JointStem | Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups | QOL | 22.68 score on a scale | Standard Error 5.383 |
| JointStem | Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups | Symptoms | 9.70 score on a scale | Standard Error 2.888 |
| Synvisc-One | Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups | QOL | 11.15 score on a scale | Standard Error 7.884 |
| Synvisc-One | Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups | Symptoms | 14.83 score on a scale | Standard Error 4.22 |
| Synvisc-One | Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups | Pain | 19.04 score on a scale | Standard Error 5.78 |
| Synvisc-One | Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups | ADL | 15.94 score on a scale | Standard Error 5.72 |
| Synvisc-One | Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups | Sport/Rec | 26.68 score on a scale | Standard Error 7.482 |
Secondary
Change From Baseline on Lysholm Knee Scoring Scale Between JointStem and Positive Control Groups
Comparing the changes of Lysholm Knee Scoring Scales between JointStem and positive control groups at 6 months Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time frame: Baseline and 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| JointStem | Change From Baseline on Lysholm Knee Scoring Scale Between JointStem and Positive Control Groups | 18.9 score on a scale | Standard Error 3.97 |
| Synvisc-One | Change From Baseline on Lysholm Knee Scoring Scale Between JointStem and Positive Control Groups | 19.9 score on a scale | Standard Error 5.78 |
Secondary
Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups
Comparing the changes of RAND-36 scores between JointStem and positive control groups at 6 months Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| JointStem | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Energy/Fatigue | 5.2 score on a scale | Standard Error 3.91 |
| JointStem | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Role Limitation (Physical) | 20.7 score on a scale | Standard Error 8.04 |
| JointStem | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Physical Functioning | 17.2 score on a scale | Standard Error 3.8 |
| JointStem | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Social Functioning | 14.71 score on a scale | Standard Error 2.964 |
| JointStem | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Role Limitation (Emotional) | 6.7 score on a scale | Standard Error 6.615 |
| JointStem | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Pain | 21.59 score on a scale | Standard Error 4.211 |
| JointStem | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | General Health | 2.91 score on a scale | Standard Error 2.516 |
| JointStem | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Emotional well-being | -3.4 score on a scale | Standard Error 2.31 |
| Synvisc-One | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | General Health | 3.13 score on a scale | Standard Error 3.668 |
| Synvisc-One | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Physical Functioning | 14.9 score on a scale | Standard Error 5.52 |
| Synvisc-One | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Role Limitation (Physical) | 17.4 score on a scale | Standard Error 11.73 |
| Synvisc-One | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Role Limitation (Emotional) | -6.74 score on a scale | Standard Error 9.654 |
| Synvisc-One | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Energy/Fatigue | 4.5 score on a scale | Standard Error 5.76 |
| Synvisc-One | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Emotional well-being | 0.5 score on a scale | Standard Error 3.45 |
| Synvisc-One | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Social Functioning | 16.16 score on a scale | Standard Error 4.312 |
| Synvisc-One | Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups | Pain | 14.7 score on a scale | Standard Error 6.18 |
Secondary
Change From Baseline on VAS Between JointStem and Positive Control Groups
Comparing the changes of VAS scores between JointStem and positive control groups at 6 months Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain.
Time frame: Baseline and 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| JointStem | Change From Baseline on VAS Between JointStem and Positive Control Groups | -31.9 score on a scale | Standard Error 4.9 |
| Synvisc-One | Change From Baseline on VAS Between JointStem and Positive Control Groups | -30.6 score on a scale | Standard Error 7.13 |
Secondary
Change From Baseline on VAS in JointStem Group
Comparing the baseline and 9-month/12-month VAS scores in JointStem group Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain.
Time frame: Baseline, 9 months and 12 months
Population: This measure was evaluated only in the JointsStem group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JointStem | Change From Baseline on VAS in JointStem Group | Change from baseline at Month 9 | -31.5 score on a scale | Standard Deviation 25.52 |
| JointStem | Change From Baseline on VAS in JointStem Group | Change from baseline at Month 12 | -35 score on a scale | Standard Deviation 24.56 |
Secondary
Change From Baseline on WOMAC Between JointStem and Positive Control Groups
Comparing the changes of WOMAC scores between JointStem and positive control groups at 6 months Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment
Time frame: Baseline and 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| JointStem | Change From Baseline on WOMAC Between JointStem and Positive Control Groups | -20.505 score on a scale | Standard Error 3.665 |
| Synvisc-One | Change From Baseline on WOMAC Between JointStem and Positive Control Groups | -17.129 score on a scale | Standard Error 5.3281 |
Secondary
Change From Baseline on WOMAC in JointStem Group
Comparing the baseline and 9-month/12-month WOMAC scores in JointStem group Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment
Time frame: Baseline, 9 months and 12 months
Population: This measure was evaluated only in the JointsStem group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JointStem | Change From Baseline on WOMAC in JointStem Group | Change from baseline at Month 9 | -21.216 score on a scale | Standard Deviation 20.9653 |
| JointStem | Change From Baseline on WOMAC in JointStem Group | Change from baseline at Month 12 | -21.711 score on a scale | Standard Deviation 19.7521 |
Secondary
Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group
Comparing the baseline and 6-month/9-month/12-month IKDC scores in JointStem group IKDC score = {(sum of each item score) / 87} \* 100 Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time frame: baseline, 6 month, 9 month, 12 month
Population: This measure was evaluated only in the JointsStem group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JointStem | Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 | 7.03 score on a scale | Standard Deviation 11.379 |
| JointStem | Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 | 10.95 score on a scale | Standard Deviation 12.047 |
| JointStem | Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 | 9.63 score on a scale | Standard Deviation 10.38 |
Secondary
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Comparing the baseline and 6-month/9-month/12-month KOOS scores in JointStem group KOOS score = 100 - \[{(average score of each item) \* 100} / 4 \] Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time frame: baseline, 6 month, 9 month, 12 month
Population: This measure was evaluated only in the JointsStem group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 (Symptoms) | 9.02 score on a scale | Standard Deviation 15.381 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 (Symptoms) | 15.03 score on a scale | Standard Deviation 13.677 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 (Symptoms) | 15.41 score on a scale | Standard Deviation 18.229 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 (Pain) | 21.65 score on a scale | Standard Deviation 20.386 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 (Pain) | 23.98 score on a scale | Standard Deviation 23.2 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 (Pain) | 25.31 score on a scale | Standard Deviation 21.219 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 (ADL) | 18.66 score on a scale | Standard Deviation 23.842 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 (ADL) | 18.42 score on a scale | Standard Deviation 25.017 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 (ADL) | 21.90 score on a scale | Standard Deviation 23.237 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 (Sport/Rec) | 25.53 score on a scale | Standard Deviation 23.915 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 (Sport/Rec) | 28.42 score on a scale | Standard Deviation 25.279 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 (Sport/Rec) | 33.68 score on a scale | Standard Deviation 24.486 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 (QOL) | 23.36 score on a scale | Standard Deviation 24.829 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 (QOL) | 29.95 score on a scale | Standard Deviation 27.228 |
| JointStem | Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 (QOL) | 28.96 score on a scale | Standard Deviation 29.121 |
Secondary
Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12
Comparing the baseline and 6-month/9-month/12-month Lysholm Knee Scoring Scale in JointStem group Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time frame: Baseline, 6 months, 9 months and 12 months
Population: This measure was evaluated only in the JointsStem group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JointStem | Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12 | Change from baseline at Month 6 | 18.3 score on a scale | Standard Deviation 22.29 |
| JointStem | Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12 | Change from baseline at Month 9 | 16.1 score on a scale | Standard Deviation 25.34 |
| JointStem | Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12 | Change from baseline at Month 12 | 17.1 score on a scale | Standard Deviation 23.78 |
Secondary
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Comparing the baseline and 6-month/9-month/12-month RAND-36 scores in JointStem group Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Time frame: baseline, 6 month, 9 month, 12 month
Population: This measure was evaluated only in the JointsStem group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 (Physical Functioning) | 17.4 score on a scale | Standard Deviation 22.13 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 (Physical Functioning) | 18.7 score on a scale | Standard Deviation 23.38 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 (Physical Functioning) | 17.1 score on a scale | Standard Deviation 28.69 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 (Role Limitation_Physical) | 22.4 score on a scale | Standard Deviation 36.22 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 (Role Limitation_Physical) | 30.3 score on a scale | Standard Deviation 38.71 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 (Role Limitation_Physical) | 31.6 score on a scale | Standard Deviation 40.69 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 (Role Limitation_Emotional) | 8.77 score on a scale | Standard Deviation 33.048 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 (Role Limitation_Emotional) | 7.02 score on a scale | Standard Deviation 30.604 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 (Role Limitation_Emotional) | 8.77 score on a scale | Standard Deviation 33.048 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 (Energy/Fatigue) | 2.9 score on a scale | Standard Deviation 20.7 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 (Energy/Fatigue) | 5.3 score on a scale | Standard Deviation 16.45 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 (Energy/Fatigue) | 7.6 score on a scale | Standard Deviation 18.81 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 (Emotional well-being) | -3.4 score on a scale | Standard Deviation 10.61 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 (Emotional well-being) | -3.6 score on a scale | Standard Deviation 11.31 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 (Emotional well-being) | -4.0 score on a scale | Standard Deviation 14.79 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 (Social Functioning) | 13.82 score on a scale | Standard Deviation 23.531 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 (Social Functioning) | 14.47 score on a scale | Standard Deviation 20.943 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 (Social Functioning) | 7.24 score on a scale | Standard Deviation 25.109 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 (Pain) | 23.16 score on a scale | Standard Deviation 21.982 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 (Pain) | 23.95 score on a scale | Standard Deviation 22.1 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 (Pain) | 24.34 score on a scale | Standard Deviation 21.967 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 6 (General Health) | 3.51 score on a scale | Standard Deviation 13.566 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 9 (General Health) | 5.71 score on a scale | Standard Deviation 10.502 |
| JointStem | Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group | Change from baseline at Month 12 (General Health) | 2.85 score on a scale | Standard Deviation 18.636 |
Secondary
Comparison of MRI Improvement Evaluation in JointStem Group
Comparing the baseline and 9-month/12-month MRI improvement values in JointStem group MRI Improvement Evaluation was conducted by an MRI analysis company called 'Qmetrics'. The main radiological features evaluated were bone marrow edema, osteophytes, and cartilage. Certain features, such as the appearance of a new cartilage defect or increase in the size of existing cartilage defects or osteophytes, is generally considered an indication of osteoarthritic progression. Similarly, the diminishing in severity or size of existing abnormalities would generally be considered to be a healing(improving) response.
Time frame: Baseline, 6 months and 12 months
Population: This measure was evaluated only in the JointsStem group. And one patient was excluded from the table due to absence of MRI values.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JointStem | Comparison of MRI Improvement Evaluation in JointStem Group | Month 6 Improved -> Month 12 Improved | 3 Participants |
| JointStem | Comparison of MRI Improvement Evaluation in JointStem Group | Month 6 Improved -> Month 12 No Change | 1 Participants |
| JointStem | Comparison of MRI Improvement Evaluation in JointStem Group | Month 6 Improved -> Month 12 Progress | 1 Participants |
| JointStem | Comparison of MRI Improvement Evaluation in JointStem Group | Month 6 No Change -> Month 12 Improved | 1 Participants |
| JointStem | Comparison of MRI Improvement Evaluation in JointStem Group | Month 6 No Change -> Month 12 No Change | 2 Participants |
| JointStem | Comparison of MRI Improvement Evaluation in JointStem Group | Month 6 No Change -> Month 12 Progress | 2 Participants |
| JointStem | Comparison of MRI Improvement Evaluation in JointStem Group | Month 6 Progress -> Month 12 Improved | 2 Participants |
| JointStem | Comparison of MRI Improvement Evaluation in JointStem Group | Month 6 Progress -> Month 12 No Change | 0 Participants |
| JointStem | Comparison of MRI Improvement Evaluation in JointStem Group | Month 6 Progress -> Month 12 Progress | 6 Participants |