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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Safety of Autologous Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair

Conditions
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Rotator Cuff

Intervention / Treatment
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* Other: Muscle Fiber Fragments (MFFs)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muscle Fiber Fragments (MFF)<br>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. | Other: Muscle Fiber Fragments (MFFs)<br>* During the rotator cuff repair procedure, a biopsy of muscle will be taken from the pectoralis major and processed under sterile conditions in the operating room to obtain MFFs. The final product, composed of autologous MFFs in suspension, will be delivered via targeted injection into the muscle belly of the supraspinatus through the Naviaser Portal with visual guidance after rotator cuff repair is complete.<br>* Other names: Autologous;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | The incidence of adverse events will be documented in the areas of product related, biopsy procedure-related, and injection-related reporting for each group. | 6 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Free Muscle Volume | Fat-free muscle volume (total muscle volume minus % of fatty infiltration). | Month 1, Month 6 | 
| Goutallier Score via MRI 1.5+ image analysis | Measured by MRI T1 Sagittal image at the Y position. Total score values 0- 4 (Grade 0 =normal muscle; Grade 1 =Muscle that contain some fatty streaks; Grade 2 = Fatty infiltration but more muscle than fat; Grade 3 = Equal amounts of fat and muscle; Grade 4 = More fat than muscle.) Lower values denotes better outcomes. | 12 weeks, 6 months post operatively | 
| Constant Score | The constant score, a 0-100 point scale with 100 being Normal and Abnormal Side >30 Poor, 21-30 Fair, 11-20 Good and <11 Excellent will measure muscle recovery including strength and level of atrophy. Higher scores denote worse outcome measures. | 12 weeks, 6 months post operatively | 
| ASES Shoulder Score | The ASES Shoulder Score (scale with a max of 100 which is normal function with no pain to minimum of 0 which is extreme pain) will measure muscle recovery. Higher scores denote better outcomes. | 12 weeks, 6 months post operatively | 
| Dynamometer measurements | Measurement will be on a scale used to measure the number of pounds or kilograms generated with arm at 90 degrees of abduction with the elbow extended. | 12 weeks, 6 months post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle Fiber Fragments, Rotator Cuff Musculature, Rotator Cuff Repair