What this study is
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).
What's being tested
- Muscle Fiber Fragments (MFFs)
Intervention · OTHER
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.
Study details
- Official title
- Safety of Autologous Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair
- Sponsor
- Wake Forest University Health Sciences
- Conditions
- Rotator Cuff
- Enrolling
- 20 people
- Starts
- 2019-11-04
- Est. completion
- 2027-12
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Males and females, ages 40 to 80 years
- Unilateral Disease
- < 1.5cm tear
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWake Forest University Health Sciences
Winston-Salem, North Carolina, United States
- Mary-Claire Day, RN · Contact336-713-1343mday@wakehealth.edu
- Gary G Poehling, MD · Principal investigator
Recruiting
Study team
Sponsor
Wake Forest University Health Sciences
Study ID IRB00054333
Principal investigator
Gary G Poehling, MD
Wake Forest University Health Sciences
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.