NCT03752034 · Wake Forest University Health Sciences
Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair
What this study is 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.
View original scientific description
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).
Interventions
OTHER
Muscle Fiber Fragments (MFFs)
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.
Primary outcome measures
Incidence of Adverse Events
Time frame: 6 months post surgery
The incidence of adverse events will be documented in the areas of product related, biopsy procedure-related, and injection-related reporting for each group.
Incidence of Adverse Events
Time frame: 12 months post surgery
The incidence of adverse events will be documented in the areas of product related, biopsy procedure-related, and injection-related reporting for each group.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males and females, ages 40 to 80 years
- Unilateral Disease
- \< 1.5cm tear
Exclusion criteria
- 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
- 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
- Winston-Salem, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations