๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-04-18

Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis (NCT04440189)

Use of GID SVF-2 Device to Produce Autologous Adipose-Derived Stromal Vascular Fraction for Treatment of Osteoarthritis of the Knee: A Pivotal Medical Device Randomized Concurrent Controlled Study

๐Ÿ”ต Active, Not Recruiting Phase3 โš™๏ธ Medical Device Protocol Sponsor: GID BIO, Inc.

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

This is a pivotal study to evaluate the efficacy and safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.

Who can join: Review the eligibility criteria below.

Location: UC Davis โ€” Sacramento, California

Age range: 35 Years to 85 Years

๐Ÿงช Interventions in This Study

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)

  • UC Davis โ€” Sacramento, California
  • Advanced Research LLC โ€” Coral Springs, Florida
  • Tulane University โ€” New Orleans, Louisiana
  • New Jersey Regenerative Institute โ€” Cedar Knolls, New Jersey
  • OrthoCarolina Research Institute โ€” Charlotte, North Carolina
  • Wake Forest University Health Sciences โ€” Winston-Salem, North Carolina
  • Ohio State University Jameson Crane Sports Medicine Institute โ€” Columbus, Ohio
  • University of Pittsburgh Medical Center โ€” Pittsburgh, Pennsylvania
  • Texas Center for Cell Therapy and Research โ€” San Antonio, Texas

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†—