Using muscle fiber fragments to enhance rotator cuff recovery
Official title: Safety of Autologous Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair
Run by Wake Forest University Health Sciences · NCT03752034 · Data updated 2026-11-12
This study is testing whether injecting muscle fiber fragments from the chest into the shoulder can help people recover better and regain strength after rotator cuff surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Status | Recruiting |
| Started | November 4, 2019 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT03752034 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males and females aged 40 to 80 with a unilateral rotator cuff tear less than 1.5 cm.
✕Probably not a fit
Patients with diabetes, previous shoulder surgery, or major comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study involves taking a biopsy of chest muscle to extract muscle fiber fragments, which are then injected into the supraspinatus muscle following rotator cuff repair. The hypothesis is that these fragments will integrate into the existing muscle tissue, potentially increasing muscle size and strength, thereby improving rotator cuff function. The approach aims to provide a less invasive alternative to traditional surgical therapies, with the goal of enhancing recovery and restoring muscle function more effectively.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients undergoing rotator cuff repair.
How similar studies have gone: While muscle fiber fragment therapy has shown promise in other conditions, this specific application for rotator cuff repair is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females, ages 40 to 80 years * Unilateral Disease * \< 1.5cm tear Exclusion Criteria: * Diabetes * Peripheral Neuropathy * Previous Shoulder Surgery * Pain Syndrome; cuff arthroplasty * Major co-morbidities including, but not limited to, uncontrolled diabetes, cardiovascular, pulmonary, GI, coagulopathies * Arthritis of Shoulder * Unwilling or unable to comply with post-operative instructions or follow-up visits * Auto Immune Disease * Complete Subscapularis Tear * Teres Minor involvement * History of testing positive for HIV, Hep B, Hep C, HTLV-1, HTLV-2 * Pregnancy * Implanted devices containing ferromagnetic material * Any implanted electrical stimulation devices (i.e. cochlear implant, defibrillator) * Any other condition which the PI feels would be not in the best interest for the patient or the study
Where it's running
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Gary G Poehling, MD — Wake Forest University Health Sciences
- Study coordinator: Mary-Clare Day, RN
- Email: mday@wakehealth.edu
- Phone: 336-713-1343
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Rotator cuff repair with biceps rerouting and dermal graft augmentation for large, difficult tears
This study tests a combined surgical approach to see if it helps tendon retear rates in adults with large rotator cuff tears that are hard to repair.
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This study tests whether biomarkers in shoulder tissue and synovial fluid can predict whether a rotator cuff repair will heal, using MRI after surgery to compare those who heal with those who don’t.
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We will see if age-related muscle loss (sarcopenia) is linked to the location and type of rotator cuff tears in adults aged 40–75 with rotator cuff syndrome.
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This study sees if people under 65 who had cervical radiculopathy before rotator cuff repair have different shoulder function and quality of life after surgery compared with those who did not.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.