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

Completed · Phase 2

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID: NCT02674399
Run by: Nature Cell Co. Ltd.
People needed: 28
Starts: 2016-02-16
Expected to finish: 2018-12-28
Last updated by the study team: 2021-08-10

Who can join

Age: 22 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Orthopedic Pain Specialists — Santa Monica, California, United States
Study site — Walnut Creek, California, United States

Full record on ClinicalTrials.gov

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