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NCT Number: NCT03752034

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

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).

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Key information

Conditions

Rotator Cuff

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Gary G Poehling, MD

PRINCIPAL_INVESTIGATOR

Mary-Claire Day, RN

CONTACT

[email protected]

336-713-1343

About this study

Muscle fiber fragment (MFF) therapy has shown pre-clinical and clinical promise in the treatment of bladder neck insufficiency/incompetent outlet. Fragmentation of muscle fibers derived from autologous muscle tissue can be injected through a needle into the sphincter region. The injected muscle fibers are able to assemble into long muscle fibers in the direction of host muscle fibers. More importantly, muscle progenitor cells residing on the fragmented muscle fibers survive and integrate into host vasculature and nerve to restore damaged muscle function. Preclinical results indicate that this technology can be used to repair and restore damaged sphincter function in urinary incontinence. The development of an autologous, readily available muscle fiber fragment treatment that may involve less risk and recovery time than those associated with the standard surgical therapies and urethral bulking agents, could alter the treatment paradigm of urinary incontinence. The study team hypothesizes that injected MFFs will incorporate into skeletal muscle and re-assemble along the fiber direction. The Investigators anticipate that the MFFs can safely be injected into the atrophied rotator cuff muscle and will help restore the functional contractile properties of the supraspinatus muscle following rotator cuff repair.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muscle Fiber Fragments (MFFs)

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.

Other names: Autologous

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Fat Free Muscle Volume

    Time frame: Month 1, Month 6, and Month 12

    Fat-free muscle volume (total muscle volume minus % of fatty infiltration).

  2. Goutallier Score via MRI 1.5+ image analysis

    Time frame: 12 weeks, 6 months, and 12 months post operatively

    Measured by MRI T1 Sagittal image at the Y position. Total score values 0- 4 (Grade 0 =normal muscle; Grade 1 =Muscle that contain some fatty streaks; Grade 2 = Fatty infiltration but more muscle than fat; Grade 3 = Equal amounts of fat and muscle; Grade 4 = More fat than muscle.) Lower values denotes better outcomes.

  3. Constant Score

    Time frame: 12 weeks, 6 months, and 12 months post operatively

    The constant score, a 0-100 point scale with 100 being Normal and Abnormal Side >30 Poor, 21-30 Fair, 11-20 Good and <11 Excellent will measure muscle recovery including strength and level of atrophy. Higher scores denote worse outcome measures.

  4. ASES Shoulder Score

    Time frame: 12 weeks, 6 months, and 12 months post operatively

    The ASES Shoulder Score (scale with a max of 100 which is normal function with no pain to minimum of 0 which is extreme pain) will measure muscle recovery. Higher scores denote better outcomes.

  5. Dynamometer measurements

    Time frame: 12 weeks, 6 months, and 12 months post operatively

    Measurement will be on a scale used to measure the number of pounds or kilograms generated with arm at 90 degrees of abduction with the elbow extended.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary-Clare Day, RN

CONTACT

[email protected]

336-713-1343

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Nov 23, 2018
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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