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A Phase II Study to Evaluate Autologous Stromal Vascular Fraction Cell Therapy to Improve the Repair of Chronically Rotator Cuff Tears
Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration. Surgical repair of the tear does not reverse the atrophy, and many patients continue to experience weakness, pain, and a persistent reduction in the quality of life. An important limitation in our ability to successfully rehabilitate these injuries postoperatively and return patients to normal function has to do with the poor quality of the muscle and tendon after rotator cuff repair. The stromal vascular fraction (SVF) of subcutaneous adipose tissue is highly enriched with cells (SVFCs) that can both directly participate in tissue regeneration by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate pathways associated with healthy tissue regeneration. High numbers of autologous SVFCs can be isolated using the cost-effective, intraoperative Icellator (Tissue Genesis, Honolulu, HI) point-of-care system. This clinical trial will be determine if the use of SVFCs can enhance outcomes for patients who are undergoing surgical repair of a torn supraspinatus rotator cuff.
Age
45 - 65 years
Sex
ALL
Healthy Volunteers
No
Hospital for Special Surgery
New York, New York, United States
Start Date
July 1, 2019
Primary Completion Date
June 23, 2026
Completion Date
July 23, 2026
Last Updated
November 25, 2025
56
ESTIMATED participants
Autologous Stomal Vascular Fraction Material
DEVICE
Ringer's solution
DEVICE
Lead Sponsor
Hospital for Special Surgery, New York
Collaborators
NCT04944836
NCT06735170
NCT07057037
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