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

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).

Conditions

Rotator Cuff

Study Overview

Study Details

Study overview

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).

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

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

Condition
Rotator Cuff
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Males and females, ages 40 to 80 years
  • * Unilateral Disease
  • * \< 1.5cm tear
  • * 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

40 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Gary G Poehling, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

2025-12