Status:
ACTIVE_NOT_RECRUITING
Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborating Sponsors:
Orthopedic Research and Education Foundation
Conditions:
Rotator Cuff Tear
Muscle Atrophy
Eligibility:
All Genders
45-65 years
Phase:
PHASE2
Brief 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. Su...
Eligibility Criteria
Inclusion
- Males and females
- Age 45-65 years old at the time of enrollment
- Full-thickness supraspinatus tendon tear with endon retraction ≤ 3 cm
- Magnetic resonance imaging Goutallier score ≤ grade 2
- Completed at least 6 weeks of standard physical therapy but continue to have pain and limited function (failed physical therapy)
- Sufficient subcutaneous abdominal adipose tissue to allow the recovery of 60-120cc of lipoaspirate
- Must pass standard of care blood work screening
Exclusion
- Any tears of any cuff tendon other than the supraspinatus
- Magnetic resonance imaging Goutallier scores ≥ 3
- Frank signs of glenohumeral osteoarthritis on magnetic resonance imaging
- A history of previous rotator cuff repair
- A history of upper extremity fracture or other moderate to severe upper extremity trauma
- A BMI \< 20 or \> 35
- Pregnant or breast feeding
- Premenopausal women who are not using contraception
- Previous abdominal liposuction or any major open abdominal surgery
- Type I or type II diabetes, or glycated hemoglobin (hemoglobin A1C) values \> 6.5 or other metabolic disorders
- Hypercholesterolemia (total cholesterol ≥240mg/dL)
- History of cancer
- Autoimmune disorder or HIV+ status
- Use of nicotine products
- Have any other history of major medical illness, disease or other relevant orthopaedic disability
- Who do not speak English
- Liodcaine allergy
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 23 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03332238
Start Date
July 1 2019
End Date
July 23 2026
Last Update
November 25 2025
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021