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NCT06828666 · ClinicalTrials.gov registry record · Phase 1
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 study of Osteoarthritis of Knee, sponsored by Britecyte.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 7
- Study locations
NCT06828666: Recruiting Phase 1 study of Osteoarthritis of Knee, sponsored by Britecyte.
NCT06828666 is a Phase 1 study of Osteoarthritis of Knee that is actively recruiting participants, run by Britecyte. The registered enrollment target is 42 participants, below the 227-participant average among 3 other Osteoarthritis of Knee trials with a reported enrollment target (81% lower). The trial reports 7 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06828666, a Phase 1 study of Osteoarthritis of Knee, is actively recruiting participants, sponsored by Britecyte.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
• Incidence and severity of local and systemic treatment-emergent adverse events (TEAEs) and SAEs
Conditions Studied
Interventions
- BIOLOGICAL Cryopreserved Devitalized Adipose Tissue Allograft
- OTHER Normal Saline (Placebo)
Study Locations (7)
Maryland
- LifeBridge Health - Baltimore
- The Osteoporosis & Clinical Trials Center - Hagerstown
- MD Medical Research - Oxon Hill
- Elevate Clinical Research - Rockville
Pennsylvania
- University Orthopedics Center - Altoona
- University Orthopedics Center - State College
New York
- Northwell Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2025-05-05 |
| Est. Completion | 2026-04 |
| Phase | Phase 1 |
What NCT06828666 shows while recruiting
NCT06828666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 227-participant average among 3 other Osteoarthritis of Knee trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Osteoarthritis of Knee appearing as the primary indexed condition, and to 2 interventions - of which Cryopreserved Devitalized Adipose Tissue Allograft is the first listed.
NCT06828666 lists 7 locations in 3 states (Maryland, Pennsylvania, New York).
Frequently Asked Questions
What is clinical trial NCT06828666 about?
NCT06828666 is a clinical study titled "A Phase 1/2a to Evaluate the Safety and Efficacy of Adipose Tissue Allograft (BRC-OA) in Patients With Osteoarthritis of the Knee". 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...
What is the current status of trial NCT06828666?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2025-05-05. Estimated completion is 2026-04.
What conditions does trial NCT06828666 study?
This clinical trial studies the following conditions: Osteoarthritis of Knee.
What interventions are being tested in trial NCT06828666?
The interventions under investigation include: Cryopreserved Devitalized Adipose Tissue Allograft (BIOLOGICAL), Normal Saline (Placebo) (OTHER).
Who is sponsoring clinical trial NCT06828666?
This trial is sponsored by Britecyte, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06828666 being conducted?
This trial has 7 study locations across Maryland, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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