NCT06828666

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

A Phase 1/2a, Multicenter, Randomized, Controlled, Single-Blind, Dose-Finding Study to Evaluate the Safety and Efficacy of Cryopreserved Devitalized Adipose Tissue Allograft (BRC-OA) for Pain Treatment in Subjects With Mild to Severe Osteoarthritis (OA) of the Knee

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Britecyte · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will be conducted in two parts: * Part 1 (Safety Evaluation phase) - without control arm * Part 2 (Randomized Controlled phase) - with control arm In Part 1, six subjects will be treated with a 7-day staggering interval between each subject's enrollment. The initial 3 subjects will receive a 2 mL dose of BRCOA, and if deemed safe and well-tolerated by the investigator, the next 3 subjects will receive an 8 mL dose, also following a 7-day staggering interval to assess safety and tolerability. Once both dose levels (2 mL and 8 mL) are confirmed to be safe and tolerable, the study will advance to Part 2. In Part 2, a total of 36 subjects (12 subjects per arm) will be randomized 1:1:1 to three parallel arms to be administered via intraarticular injection of 2 mL or 8 mL of BRC-OA, or 2 mL of normal saline (control).

Conditions

• Osteoarthritis of Knee

Interventions

Type	Name	Description
BIOLOGICAL	Cryopreserved Devitalized Adipose Tissue Allograft	BRC-OA is a Cryopreserved Devitalized Adipose Tissue Allograft that has demonstrated anti-inflammatory and antioxidant properties of adipose tissue.
OTHER	Normal Saline (Placebo)	2 mL Normal Saline

Timeline

• Start date: 2025-05-05
• Primary completion: 2026-02-15
• Completion: 2026-08-01
• First posted: 2025-02-14
• Last updated: 2026-04-07

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study