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CompletedNCT02674399Updated Aug 10, 2021Results posted

A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis

A Phase 2 interventional study of JointStem and Synvisc-One in Osteoarthritis, Knee, sponsored by Nature Cell Co. Ltd.. Completed at 2 sites in United States. Open to participants aged 22 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-08-10.

Sponsored by Nature Cell Co. Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
22 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis, Knee
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 28 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Nature Cell Co. Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 60 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    JointStem

    autologous adipose tissue derived mesenchymal stem cells (AdMSC)

    Drug: JointStem

  • Active comparator
    Synvisc-One

    hyaluronic acid

    Drug: Synvisc-One

Interventions

  • DrugJointStem
  • DrugSynvisc-One

    Also known as: Active Comparator

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

07

Results

Posted Jul 13, 2021

Participant flow

Participant flow — Overall Study
MilestoneJointStemSynvisc-One
Started199
Completed179
Not completed20
Withdrew: Lost to follow-up20

Outcome measures

PrimaryChange 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
Reported as:
Mean · score on a scale
Change From Baseline on Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score in JointStem Group
score on a scaleJointStemSynvisc-One
Change From Baseline on Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score in JointStem Group-20.121 ± 21.0415—
PrimaryChange 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
Reported as:
Mean · score on a scale
Change From Baseline on Visual Analog Scale (VAS) in JointStem Group
score on a scaleJointStemSynvisc-One
Change From Baseline on Visual Analog Scale (VAS) in JointStem Group-32.5 ± 23.93—
PrimaryMRI 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
Reported as:
Count of participants · Participants
MRI Improvement Evaluation in JointStem Group
ParticipantsJointStemSynvisc-One
Improvement50
No Change50
Progress80
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline on WOMAC Between JointStem and Positive Control Groups
score on a scaleJointStemSynvisc-One
Change From Baseline on WOMAC Between JointStem and Positive Control Groups-20.505 ± 3.665-17.129 ± 5.3281
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline on VAS Between JointStem and Positive Control Groups
score on a scaleJointStemSynvisc-One
Change From Baseline on VAS Between JointStem and Positive Control Groups-31.9 ± 4.90-30.6 ± 7.13
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups
score on a scaleJointStemSynvisc-One
Symptoms9.70 ± 2.88814.83 ± 4.22
Pain21.40 ± 3.97519.04 ± 5.78
ADL18.53 ± 3.93715.94 ± 5.72
Sport/Rec25.00 ± 5.12326.68 ± 7.482
QOL22.68 ± 5.38311.15 ± 7.884
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline on Lysholm Knee Scoring Scale Between JointStem and Positive Control Groups
score on a scaleJointStemSynvisc-One
Change From Baseline on Lysholm Knee Scoring Scale Between JointStem and Positive Control Groups18.9 ± 3.9719.9 ± 5.78
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline on International Knee Documentation Committee (IKDC) Between JointStem and Positive Control Groups
score on a scaleJointStemSynvisc-One
Change From Baseline on International Knee Documentation Committee (IKDC) Between JointStem and Positive Control Groups55.74 ± 2.22354.24 ± 3.238
SecondaryChange 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
Reported as:
Least squares mean · score on a scale
Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups
score on a scaleJointStemSynvisc-One
Physical Functioning17.2 ± 3.8014.9 ± 5.52
Role Limitation (Physical)20.7 ± 8.0417.4 ± 11.73
Role Limitation (Emotional)6.7 ± 6.615-6.74 ± 9.654
Energy/Fatigue5.2 ± 3.914.5 ± 5.76
Emotional well-being-3.4 ± 2.310.5 ± 3.45
Social Functioning14.71 ± 2.96416.16 ± 4.312
Pain21.59 ± 4.21114.7 ± 6.18
General Health2.91 ± 2.5163.13 ± 3.668
SecondaryChange 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
Reported as:
Mean · score on a scale
Change From Baseline on WOMAC in JointStem Group
score on a scaleJointStemSynvisc-One
Change from baseline at Month 9-21.216 ± 20.9653—
Change from baseline at Month 12-21.711 ± 19.7521—
SecondaryChange 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
Reported as:
Mean · score on a scale
Change From Baseline on VAS in JointStem Group
score on a scaleJointStemSynvisc-One
Change from baseline at Month 9-31.5 ± 25.52—
Change from baseline at Month 12-35 ± 24.56—
SecondaryComparison 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
Reported as:
Count of participants · Participants
Comparison of MRI Improvement Evaluation in JointStem Group
ParticipantsJointStemSynvisc-One
Month 6 Improved -> Month 12 Improved3—
Month 6 Improved -> Month 12 No Change1—
Month 6 Improved -> Month 12 Progress1—
Month 6 No Change -> Month 12 Improved1—
Month 6 No Change -> Month 12 No Change2—
Month 6 No Change -> Month 12 Progress2—
Month 6 Progress -> Month 12 Improved2—
Month 6 Progress -> Month 12 No Change0—
Month 6 Progress -> Month 12 Progress6—
SecondaryChange 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
Reported as:
Mean · score on a scale
Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12
score on a scaleJointStemSynvisc-One
Change from baseline at Month 618.3 ± 22.29—
Change from baseline at Month 916.1 ± 25.34—
Change from baseline at Month 1217.1 ± 23.78—
SecondaryChange 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
Reported as:
Mean · score on a scale
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
score on a scaleJointStemSynvisc-One
Change from baseline at Month 6 (Symptoms)9.02 ± 15.381—
Change from baseline at Month 9 (Symptoms)15.03 ± 13.677—
Change from baseline at Month 12 (Symptoms)15.41 ± 18.229—
Change from baseline at Month 6 (Pain)21.65 ± 20.386—
Change from baseline at Month 9 (Pain)23.98 ± 23.200—
Change from baseline at Month 12 (Pain)25.31 ± 21.219—
Change from baseline at Month 6 (ADL)18.66 ± 23.842—
Change from baseline at Month 9 (ADL)18.42 ± 25.017—
Change from baseline at Month 12 (ADL)21.90 ± 23.237—
Change from baseline at Month 6 (Sport/Rec)25.53 ± 23.915—
Change from baseline at Month 9 (Sport/Rec)28.42 ± 25.279—
Change from baseline at Month 12 (Sport/Rec)33.68 ± 24.486—
Change from baseline at Month 6 (QOL)23.36 ± 24.829—
Change from baseline at Month 9 (QOL)29.95 ± 27.228—
Change from baseline at Month 12 (QOL)28.96 ± 29.121—
SecondaryChange 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
Reported as:
Mean · score on a scale
Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group
score on a scaleJointStemSynvisc-One
Change from baseline at Month 67.03 ± 11.379—
Change from baseline at Month 910.95 ± 12.047—
Change from baseline at Month 129.63 ± 10.380—
SecondaryChange 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
Reported as:
Mean · score on a scale
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
score on a scaleJointStemSynvisc-One
Change from baseline at Month 6 (Physical Functioning)17.4 ± 22.13—
Change from baseline at Month 9 (Physical Functioning)18.7 ± 23.38—
Change from baseline at Month 12 (Physical Functioning)17.1 ± 28.69—
Change from baseline at Month 6 (Role Limitation_Physical)22.4 ± 36.22—
Change from baseline at Month 9 (Role Limitation_Physical)30.3 ± 38.71—
Change from baseline at Month 12 (Role Limitation_Physical)31.6 ± 40.69—
Change from baseline at Month 6 (Role Limitation_Emotional)8.77 ± 33.048—
Change from baseline at Month 9 (Role Limitation_Emotional)7.02 ± 30.604—
Change from baseline at Month 12 (Role Limitation_Emotional)8.77 ± 33.048—
Change from baseline at Month 6 (Energy/Fatigue)2.9 ± 20.70—
Change from baseline at Month 9 (Energy/Fatigue)5.3 ± 16.45—
Change from baseline at Month 12 (Energy/Fatigue)7.6 ± 18.81—
Change from baseline at Month 6 (Emotional well-being)-3.4 ± 10.61—
Change from baseline at Month 9 (Emotional well-being)-3.6 ± 11.31—
Change from baseline at Month 12 (Emotional well-being)-4.0 ± 14.79—
Change from baseline at Month 6 (Social Functioning)13.82 ± 23.531—
Change from baseline at Month 9 (Social Functioning)14.47 ± 20.943—
Change from baseline at Month 12 (Social Functioning)7.24 ± 25.109—
Change from baseline at Month 6 (Pain)23.16 ± 21.982—
Change from baseline at Month 9 (Pain)23.95 ± 22.100—
Change from baseline at Month 12 (Pain)24.34 ± 21.967—
Change from baseline at Month 6 (General Health)3.51 ± 13.566—
Change from baseline at Month 9 (General Health)5.71 ± 10.502—
Change from baseline at Month 12 (General Health)2.85 ± 18.636—

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
JointStem0/19 (0%)0/19 (0%)18/19 (94.7%)
Synvisc-One0/9 (0%)0/9 (0%)4/9 (44.4%)
Most frequent other events
Showing 10 of 25
Most frequent other events
EventJointStemSynvisc-One
Injection site painGeneral disorders9/191/9
ArthralgiaMusculoskeletal and connective tissue disorders7/192/9
Joint swellingMusculoskeletal and connective tissue disorders5/190/9
Stiff kneesMusculoskeletal and connective tissue disorders4/191/9
TendonitisMusculoskeletal and connective tissue disorders0/191/9
BronchitisInfections and infestations2/191/9
PneumoniaInfections and infestations0/191/9
Ligament sprainInjury, poisoning and procedural complications2/191/9
Ligament ruptureInjury, poisoning and procedural complications0/191/9
NasopharyngitisInfections and infestations2/190/9

Baseline characteristics

Age, Continuous
Age, Continuous(years)JointStemSynvisc-OneTotal
Mean52.3 ± 6.9852.1 ± 9.5652.3 ± 7.72
Sex: Female, Male
Sex: Female, Male(Participants)JointStemSynvisc-OneTotal
Female8210
Male11718
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)JointStemSynvisc-OneTotal
Hispanic or Latino112
Not Hispanic or Latino18826
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)JointStemSynvisc-OneTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American213
White16723
More than one race000
Unknown or Not Reported112
Height
Height(cm)JointStemSynvisc-OneTotal
Mean173.66 ± 9.222169.46 ± 10.073172.31 ± 9.527
Weight
Weight(kg)JointStemSynvisc-OneTotal
Mean81.31 ± 14.64271.66 ± 20.56978.2 ± 17.01
BMI
BMI(kg/m^2)JointStemSynvisc-OneTotal
Mean26.903 ± 4.193824.572 ± 4.640826.154 ± 4.3971
08

Study locations

2 sites
  • Orthopedic Pain Specialists
    Santa Monica, California 90404, United States
  • Walnut Creek, California 94598, United States
09

References and documents

Study documents

  • Study protocol · May 14, 2018
  • Statistical analysis plan · Apr 5, 2018
  • Informed consent form · May 30, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02674399
Lead sponsor
Nature Cell Co. Ltd.
Collaborators
KCRN Research, LLC
Responsible party
Sponsor
First posted
Feb 4, 2016
Start date
Feb 16, 2016
Primary completion
Mar 12, 2018
Completion
Dec 28, 2018
Results posted
Jul 13, 2021
Last update
Aug 10, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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