Recruiting

Muscle Fiber Fragments

Sponsor:

Wake Forest University Health Sciences

Code:

NCT03752034

Conditions

Rotator Cuff

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Muscle Fiber Fragments (MFFs)

Study Details

Brief summary:

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).

Conditions

Rotator Cuff

Study ID

NCT03752034

Start date

Nov 4, 2019

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Muscle Fiber Fragments (MFF)

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.

Interventions

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 measure

  • Incidence of Adverse Events [ Time Frame: 6 months post surgery ]
  • Incidence of Adverse Events [ Time Frame: 12 months post surgery ]

Central Contacts and Locations

Central contacts

Mary-Clare Day, RN

336-713-1343mday@wakehealth.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Mary-Claire Day, RN

336-713-1343mday@wakehealth.edu

Principal Investigator:

Gary G Poehling, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Muscle Fiber Fragments
  • Rotator Cuff Musculature
  • Rotator Cuff Repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-03-27.