Adipose Tissue Allograft for Knee Arthritis

Recruiting at 5 trial locations

Overseen By Matthew Gaver

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Britecyte

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Molly Saunders

Principal Investigator

Sr. Director, Regenerative Medicine Programs

Eligibility Criteria

Inclusion Criteria

My joint bends and twists less than 10 degrees from normal.

I can take acetaminophen.

I use NSAID pain relievers like ibuprofen or naproxen.

Treatment Details

Participant Groups

Group I: Part 2 - 8 mL of BRC-OA via intra-articular injection Experimental Treatment 1 Intervention

Group II: Part 2 - 2 mL of BRC-OA via intra-articular injection Experimental Treatment 1 Intervention

Group III: Part 1 - 8 mL of BRC-OA via intra-articular injection Experimental Treatment 1 Intervention

Group IV: Part 1 - 2 mL of BRC-OA via intra-articular injection Experimental Treatment 1 Intervention

Group V: Part 2 - 2 mL of Normal Saline via intra-articular injection Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Britecyte

Lead Sponsor

Trials

1

Recruited

40+

Amarex Clinical Research

Collaborator

Trials

28

Recruited

1,700+