๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-06-11

Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis (NCT06121882)

A Randomized, Multi-center, Double Blind, Parallel Study to Examine the Effect of Lipogems Processed Microfragmented Adipose Tissue in Comparison to Saline for the Treatment of Knee Osteoarthritis

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Lipogems International spa

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

The goal of this clinical trial is to examine the effect of a single autologous, intra-articular injection of MFat versus saline injection for the treatment of pain and function associated with K/L grade 2/3 knee Osteoarthritis. Participants will receive an injection of MFat or saline.

Who can join: Review the eligibility criteria below.

Location: Arizona Bone, Joint and Sports Medicine Center LLC โ€” Phoenix, Arizona

Age range: 18 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 (16 Sites)

  • Arizona Bone, Joint and Sports Medicine Center LLC โ€” Phoenix, Arizona
  • CORE Orthopaedic Medical Center โ€” Encinitas, California
  • Horizon Clinical Research โ€” La Mesa, California
  • Andrews Research & Ed Foundation โ€” Gulf Breeze, Florida
  • Hospital for Special Surgery Florida โ€” West Palm Beach, Florida
  • Pinnacle Trials, Inc โ€” Atlanta, Georgia
  • Fascia Institute and Treatment (FIT) Center โ€” Metairie, Louisiana
  • Ochsner Sports Medicine Institute โ€” New Orleans, Louisiana
  • Regenerative Orthopedics & Sports Medicine โ€” Rockville, Maryland
  • Mayo Clinic - Rochester โ€” Rochester, Minnesota
  • The Orthopedic Center - NextStage Clinical Research - Tulsa โ€” Tulsa, Oklahoma
  • LeHigh Center for Clinical Research โ€” Allentown, Pennsylvania
  • Coastal Carolina Research Center โ€” North Charleston, South Carolina
  • Vanderbilt Orthopaedics โ€” Nashville, Tennessee
  • All American Ortho - NextStage Clinical Research โ€” Houston, Texas
  • Texas Center for Cell Therapy and Research, LLC 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†—