๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-07-30

Safety and Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis (NCT05835895)

A Phase 1b, Randomized, Double-Blinded, Placebo-Controlled Dose Ranging Study to Evaluate Safety, Tolerability and Pharmacodynamics of a Single Intra-articular Injection of GNSC-001 Gene Therapy in Subjects With Osteoarthritis of the Knee

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Genascence Corporation

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The goal of this clinical study is to determine if a single injection of 1 or more dose levels of adeno-associated virus (AAV) gene therapy (GNSC-001) is safe and tolerated compared to placebo in participants with painful osteoarthritis (OA) of the knee.

Who can join: Review the eligibility criteria below.

Location: Alliance for Medical Research Mobile โ€” Mobile, Alabama

Age range: 40 Years to 75 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (9 Sites)

  • Alliance for Medical Research Mobile โ€” Mobile, Alabama
  • Biosolutions Clinical Research Center โ€” La Mesa, California
  • UC San Diego โ€” San Diego, California
  • Well Pharma Medical Research โ€” Miami, Florida
  • South Florida Research โ€” Miami Springs, Florida
  • Premier Medical Associates โ€” The Villages, Florida
  • Alliance for Multispecialty Research Kansas City โ€” Kansas City, Missouri
  • West Clinical Research โ€” Morehead City, North Carolina
  • Altoona Center for Clinical Research โ€” Duncansville, Pennsylvania

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—