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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jun 23, 2026 → Dec 31, 2026
See other at-risk trials from Hospital for Special Surgery, New York

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Jun 23, 2026 to Dec 31, 2026
    • Study completion pushed from Jul 23, 2026 to Dec 31, 2027
    v21
  2. Minor 2 versions Re-verified since Nov 20, 2025, no change to tracked fieldsv19-v20
  3. Notable Primary completion date: Jun 23, 2025 to Jun 23, 2026
    • Study completion date: Jul 23, 2025 to Jul 23, 2026
    v18
  4. Minor Re-verified, no change to tracked fieldsv17
  5. Notable Primary completion date: Jan 23, 2024 to Jun 23, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jan 23, 2024 to Jul 23, 2025
    • Site details revised
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Notable Primary and study completion dates: Feb 26, 2023 to Jan 23, 2024v15
  2. Notable Primary completion date: Jul 31, 2022 to Feb 26, 2023
    • Study completion date: Dec 31, 2022 to Feb 26, 2023
    v14
  3. Minor Site contact updatedv13
  4. Minor Re-verified, no change to tracked fieldsv12
  5. Minor Start date changed from estimate of Jun 10, 2019 to Jul 1, 2019v11
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 31, 2021 to Jul 31, 2022
    • Study completion date: Dec 31, 2021 to Dec 31, 2022
    • Site details revised
    v10
  7. Notable Start date: May 1, 2019 to Jun 10, 2019v9
  8. Notable Start date: Mar 1, 2019 to May 1, 2019
    • Primary endpoint revised
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 5 to 3
    v8
  9. Notable Start date: Dec 1, 2018 to Mar 1, 2019
    • Primary completion date: Dec 31, 2021 to Mar 31, 2021
    • Study completion date: Dec 31, 2022 to Dec 31, 2021
    • Eligibility criteria expanded, about 54 words
    v7
  10. Notable Start date: Jun 1, 2018 to Dec 1, 2018v6
  11. Notable Start date: Apr 1, 2018 to Jun 1, 2018
    • Secondary endpoints: 6 to 5
    • Collaborators expanded, about 5 words
    v5
  12. Notable Start date: Mar 1, 2018 to Apr 1, 2018v4
  13. Minor Start date: Feb 1, 2018 to Mar 1, 2018v3
  14. Notable Start date: Jan 1, 2018 to Feb 1, 2018v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03332238
Lead Sponsor Hospital for Special Surgery, New York
Collaborators: Orthopedic Research and Education Foundation
Conditions
(from sponsor)
Rotator Cuff Tear, Muscle Atrophy, Tendon Tear
Related terms Muscular Atrophy, Rotator Cuff Injuries
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov