Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears (NCT03332238) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears
United States56 participantsStarted 2019-07-01
Plain-language 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.
Who can participate
Age range
45 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in scapular plane abduction strength from baseline, and additional isometric, isokinetic strength measurements to assess supraspinatus function.
Timeframe: 2 weeks prior to surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery