A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis
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ClinicalTrials.gov Identifier: NCT02674399 |
Recruitment Status
:
Active, not recruiting
First Posted
: February 4, 2016
Last Update Posted
: August 29, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis, Knee | Drug: JointStem Drug: Synvisc-One | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Double-Blind, Randomized, Controlled Study to Evaluate the Efficacy and Safety of JointStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Treatment of Osteoarthritis |
Actual Study Start Date : | February 16, 2016 |
Estimated Primary Completion Date : | September 2017 |
Estimated Study Completion Date : | March 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: JointStem
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
|
Drug: JointStem |
Active Comparator: Synvisc-One
hyaluronic acid
|
Drug: Synvisc-One
Other Name: Active Comparator
|
- Change from baseline on WOMAC (Western Ontario and McMaster Universities Arthritis Index) score in JointStem group [ Time Frame: Baseline and 6 months ]
- Change from baseline on VAS (Visual Analog Scale) in JointStem group [ Time Frame: Baseline and 6 months ]
- MRI Improvement Evaluation in JointStem group [ Time Frame: 6 months ]
- Change from baseline on WOMAC between JointStem and postive control groups [ Time Frame: Baseline and 6 months ]
- Change from baseline on VAS (Visual Analog Scale) between JointStem and postive control groups [ Time Frame: Baseline and 6 months ]
- Change from baseline on KOOS (Knee Injury & Osteoarthritis Outcome Score) between JointStem and postive control groups [ Time Frame: Baseline and 6 months ]
- Change from baseline on Lysholm Knee Scoring Scale between JointStem and postive control groups [ Time Frame: Baseline and 6 months ]
- Change from baseline on IKDC (International Knee Documentation Committee) between JointStem and postive control groups [ Time Frame: Baseline and 6 months ]
- Change from baseline on RAND-36 Score between JointStem and postive control groups [ Time Frame: Baseline and 6 months ]
- Change from baseline on WOMAC in JointStem group [ Time Frame: Baseline, 9 months and 12 months ]
- Change from baseline on VAS (Visual Analog Scale) in JointStem group [ Time Frame: Baseline, 9 months and 12 months ]
- Comparison of MRI improvement evaluation in JointStem group [ Time Frame: Baseline, 6 months and 12 months ]
- Change from baseline on KOOS in JointStem group [ Time Frame: Baseline, 6 months, 9 months and 12 months ]
- Change from baseline on Lysholm Knee Scoring Scale in JointStem group [ Time Frame: Baseline, 6 months, 9 months and 12 months ]
- Change from baseline on IKDC in JointStem group [ Time Frame: Baseline, 6 months, 9 months and 12 months ]
- Change from baseline on RAND-36 Score in JointStem group [ Time Frame: Baseline, 6 months, 9 months and 12 months ]
- Incidence of adverse events and laboratory abnormalities [ Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months and 12 months ]

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Ages Eligible for Study: | 22 Years to 60 Years (Adult) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674399
United States, California | |
Orthopedic Pain Specialists | |
Santa Monica, California, United States, 90404 | |
Walnut Creek, California, United States, 94598 |
Study Director: | Hugh Lee, MS | KCRN Research |
Responsible Party: | Nature Cell Co. Ltd. |
ClinicalTrials.gov Identifier: | NCT02674399 History of Changes |
Other Study ID Numbers: |
JS-OAP2-US01 |
First Posted: | February 4, 2016 Key Record Dates |
Last Update Posted: | August 29, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Additional relevant MeSH terms:
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Hylan Viscosupplements Protective Agents Physiological Effects of Drugs |