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

Wake Forest University (WFU)

Status: Enrolling

Conditions: Rotator Cuff

Treatments: Other: Muscle Fiber Fragments (MFFs)

Study type: Interventional

Funder types: Other

Identifiers

NCT03752034

IRB00054333

Details and patient eligibility

About

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).

Full description

Muscle fiber fragment (MFF) therapy has shown pre-clinical and clinical promise in the treatment of bladder neck insufficiency/incompetent outlet. Fragmentation of muscle fibers derived from autologous muscle tissue can be injected through a needle into the sphincter region. The injected muscle fibers are able to assemble into long muscle fibers in the direction of host muscle fibers. More importantly, muscle progenitor cells residing on the fragmented muscle fibers survive and integrate into host vasculature and nerve to restore damaged muscle function. Preclinical results indicate that this technology can be used to repair and restore damaged sphincter function in urinary incontinence. The development of an autologous, readily available muscle fiber fragment treatment that may involve less risk and recovery time than those associated with the standard surgical therapies and urethral bulking agents, could alter the treatment paradigm of urinary incontinence. The study team hypothesizes that injected MFFs will incorporate into skeletal muscle and re-assemble along the fiber direction. The Investigators anticipate that the MFFs can safely be injected into the atrophied rotator cuff muscle and will help restore the functional contractile properties of the supraspinatus muscle following rotator cuff repair.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Muscle Fiber Fragments (MFF)

Experimental group

Description:

Participants undergoing rotator cuff repair will have autologous muscle tissue harvested. The tissue will be processed to obtain Muscle Fiber Fragments (MFFs) and administered via direct injection into the supraspinatus muscle belly.

Treatment:

Other: Muscle Fiber Fragments (MFFs)