Study of BBM-A101 Gene Therapy to Treat Moderate Knee Osteoarthritis in Adults Aged 40 to 75

What this Trial Is About

Researchers are evaluating BBM-A101, an AAV-based gene therapy, to treat people with moderate knee osteoarthritis. The study aims to assess the safety, tolerability, and effectiveness of this treatment. It is a Phase 1 clinical study with two parts Phase Ia, which is randomized and single-blind, and Phase Ib, which is randomized and double-blind with parallel groups. Participants receive a single 2 ml injection of BBM-A101 directly into the knee joint. In Phase Ia, there are low, middle, and high dose groups along with a placebo group. In Phase Ib, participants are assigned to either low or high dose groups or a placebo group. The study compares these groups to evaluate the treatment effects and safety. During the study, participants undergo regular assessments including monitoring of adverse events and serious adverse events for up to one year. Researchers will also measure gene expression protein levels, virus shedding in various bodily fluids, changes in knee joint space by X-ray, and antibody responses over a period of up to five years. Participants are followed closely with lab tests, imaging, and clinical evaluations to track outcomes and safety throughout the study duration.

A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of BBM-A101 in the Treatment of Knee Osteoarthritis.