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RecruitingNot ApplicableNCT03752034

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

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

Sponsor

Wake Forest University Health Sciences

Enrollment

20 participants

Start Date

Nov 4, 2019

Study Type

INTERVENTIONAL

Conditions

Rotator Cuff

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).

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria3

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

Exclusion Criteria15

  • 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

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Interventions

OTHERMuscle 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.

Locations(1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

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NCT03752034