A Phase 1/2a to Evaluate the Safety and Efficacy of Adipose Tissue Allograft (BRC-OA) in Patients… (NCT06828666) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Phase 1/2a to Evaluate the Safety and Efficacy of Adipose Tissue Allograft (BRC-OA) in Patients With Osteoarthritis of the Knee
United States42 participantsStarted 2025-05-05
Plain-language summary
The purpose of this study is to evaluate the safety profile of BRC-OA for pain treatment in patients with mild to severe OA of the knee, focusing particularly on two distinct doses. Alongside safety assessments, the study also aims to investigate the initial efficacy of BRC-OA in treating pain among these patients. The study product is a cryopreserved devitalized adipose tissue allograft (BRC-OA). BRC-OA is composed of a devitalized human adipose particulate that retains the inherent properties of adipose such as tissue architecture, extracellular matrix, and signaling molecules.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Males or females 18-80 years of age, inclusive
✓. Diagnosis of OA in one or both knees supported by documentation of clinical and radiographic findings(KL Grades 2-4) up to 6 months prior to screening:
✓. Diagnosis of degenerative or post-traumatic OA of the knee supported by documentation of clinical and radiographic findings up to 6 months prior to screening
✓. Degenerative meniscal tears allowed as long as there are no pending surgeries
✓. Flexion Contraction and Valgus/Varus deformity allowed if \< 10 degrees
✓. Subject must have tried for at least 3 months and failed on at least two of the following pharmacological standard of care therapies in the past 12 months:
. Previous IA injections (e.g., corticosteroid, hyaluronic acid (HA), platelet rich plasma (PRP), etc.) into the index knee within 3 months prior to screening
✕. Prior Partial Joint Replacement (PJR) or Total Joint Replacement (TJR) of one or both knees
✕. Knee surgery in the previous 6 months prior to enrollment and/or planned knee surgery during the study
✕. Symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee
✕. Rapidly progressing osteoarthritis (RPOA)
✕. Prior cartilage transplants in the index knee
✕. Subjects who are actively treated with oral anticoagulants or heparin therapy (treatment such as low dose Aspirin and Plavix are allowed)