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

NCT06828666 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Osteoarthritis of Knee

Interventions

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

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • Britecyte

    lead NETWORK

Principal Investigators

  • Alla Danilkovitch · Founder & Chief Scientific Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-05
Primary Completion
2026-02-15
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06828666 on ClinicalTrials.gov