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NCT03332238 · ClinicalTrials.gov registry record · Phase 2
Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears
A Phase 2 study of Rotator Cuff Tear and Muscle Atrophy, sponsored by Hospital for Special Surgery, New York.
- Active
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT03332238: Active Phase 2 study of Rotator Cuff Tear and Muscle Atrophy, sponsored by Hospital for Special Surgery, New York.
NCT03332238 is a Phase 2 study of Rotator Cuff Tear and Muscle Atrophy that is active but no longer recruiting, run by Hospital for Special Surgery, New York. The registered enrollment target is 56 participants, below the 89-participant average among 11 other Rotator Cuff Tear trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03332238, a Phase 2 study of Rotator Cuff Tear and Muscle Atrophy, is active but no longer recruiting, sponsored by Hospital for Special Surgery, New York.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Autologous Stomal Vascular Fraction Material
- DEVICE Ringer's solution
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2026-07-23 |
| Phase | Phase 2 |
What the registry record for NCT03332238 still lists
NCT03332238 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 89-participant average among 11 other Rotator Cuff Tear trials with a reported enrollment target (37% lower).
The record links to 3 conditions, with Rotator Cuff Tear appearing as the primary indexed condition, and to 2 interventions - of which Autologous Stomal Vascular Fraction Material is the first listed.
NCT03332238 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03332238 about?
NCT03332238 is a clinical study titled "Stromal Vascular Fraction Cell Therapy to Improve the Repair of 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 wea...
What is the current status of trial NCT03332238?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2019-07-01. Estimated completion is 2026-07-23.
What conditions does trial NCT03332238 study?
This clinical trial studies the following conditions: Rotator Cuff Tear, Muscle Atrophy, Tendon Tear.
What interventions are being tested in trial NCT03332238?
The interventions under investigation include: Autologous Stomal Vascular Fraction Material (DEVICE), Ringer's solution (DEVICE).
Who is sponsoring clinical trial NCT03332238?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03332238 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03332238's enrollment target sits among peer trials
56 10th of 11 higher than 2 of 11 other Rotator Cuff Tear trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rotator Cuff Tear trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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