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ACTIVE NOT RECRUITING
NCT03332238
PHASE2

Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears

Sponsor: Hospital for Special Surgery, New York

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase II Study to Evaluate Autologous Stromal Vascular Fraction Cell Therapy to Improve the Repair of Chronically Rotator Cuff Tears

Key Details

Gender

All

Age Range

45 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2019-07-01

Completion Date

2026-07-23

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

DEVICE

Autologous Stomal Vascular Fraction Material

Autologous Stomal Vascular Fraction Material Prepared from the Tissue Genesis® Icellator Cell Isolation System™

DEVICE

Ringer's solution

Ringer's solution

Locations (1)

Hospital for Special Surgery

New York, New York, United States