A Phase 1/2a to Evaluate the Safety and Efficacy of Adipose Tissue Allograft (BRC-OA) in Patients With Osteoarthritis of the Knee

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.

Timeline

Start

2025-05-05

Primary completion

2026-02-15

Completion

2026-08

Drugs

Indications