๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-08-15

Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears (NCT03752827)

A Prospective, Double-Blinded, Multi-Center Pivotal Trial of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic ๐Ÿ’Š Investigational Drug / Biologic Sponsor: InGeneron, Inc.

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

The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space.

Who can join: Review the eligibility criteria below.

Location: Arizona Research Center โ€” Phoenix, Arizona

Age range: 30 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 (14 Sites)

  • Arizona Research Center โ€” Phoenix, Arizona
  • Biosolutions Clinical Research Center โ€” La Mesa, California
  • Lotus Clinical Research, LLC โ€” Pasadena, California
  • Sports and Orthopedic Center โ€” Coral Springs, Florida
  • Universal Axon Clinical Research โ€” Doral, Florida
  • Shrock Clinical Research โ€” Fort Lauderdale, Florida
  • Andrews Institute for Orthopaedics and Sports Medicine โ€” Gulf Breeze, Florida
  • Georgia Institute for Clinical Research โ€” Marietta, Georgia
  • Tulane University School of Medicine โ€” New Orleans, Louisiana
  • University of Michigan โ€” Ann Arbor, Michigan
  • Sanford Medical Center โ€” Fargo, North Dakota
  • Sanford Orthopedic Clinic/Research โ€” Sioux Falls, South Dakota
  • HD Research โ€” Houston, Texas
  • Texas Plastic Surgery 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†—