Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair

Recruiting now · Not applicable

Conditions studied: Rotator Cuff

In brief

In this study, a chest muscle sample (biopsy) will be taken and the muscle fibers will be removed from the sample and made into smaller strands or fragments. During this same procedure, those muscle fiber fragments (MFFs) will then be injected directly into the supraspinatus muscle. Once injected, the MFFs will remain in the supraspinatus where Investigators believe the MFF will become part of the participants' existing muscle and provide increased muscle size and strength, improving function (rotator cuff strength and stability).

Key facts

Study ID

NCT03752034

Run by

Wake Forest University Health Sciences

People needed

20

Starts

2019-11-04

Expected to finish

2027-12-01

Last updated by the study team

2026-03-27

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, ages 40 to 80 years
• Unilateral Disease
• < 1.5cm tear

You may not qualify if…

• 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 is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.