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

NCT03752034 | Recruiting DMC

• 1 other identifier: IRB00054333
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Muscle Fiber Fragments; Rotator Cuff Musculature; Rotator Cuff Repair

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

  The incidence of adverse events will be documented in the areas of product related, biopsy procedure-related, and injection-related reporting for each group.

  6 months post surgery

• Incidence of Adverse Events

  The incidence of adverse events will be documented in the areas of product related, biopsy procedure-related, and injection-related reporting for each group.

  12 months post surgery

Secondary Outcomes (5)

• Fat Free Muscle Volume

  Month 1, Month 6, and Month 12

• Goutallier Score via MRI 1.5+ image analysis

  12 weeks, 6 months, and 12 months post operatively

• Constant Score

  12 weeks, 6 months, and 12 months post operatively

• ASES Shoulder Score

  12 weeks, 6 months, and 12 months post operatively

• Dynamometer measurements

  12 weeks, 6 months, and 12 months post operatively

Study Arms (1)

Muscle Fiber Fragments (MFF)

EXPERIMENTAL

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.

Other: Muscle Fiber Fragments (MFFs)

Interventions

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.

Also known as: Autologous

Muscle Fiber Fragments (MFF)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Related Publications (12)

• Deniz G, Kose O, Tugay A, Guler F, Turan A. Fatty degeneration and atrophy of the rotator cuff muscles after arthroscopic repair: does it improve, halt or deteriorate? Arch Orthop Trauma Surg. 2014 Jul;134(7):985-90. doi: 10.1007/s00402-014-2009-5. Epub 2014 May 21.

  PMID: 24845686 BACKGROUND

• Eberli D, Aboushwareb T, Soker S, Yoo JJ, Atala A. Muscle precursor cells for the restoration of irreversibly damaged sphincter function. Cell Transplant. 2012;21(9):2089-98. doi: 10.3727/096368911X623835. Epub 2012 Jan 10.

  PMID: 22236637 BACKGROUND

• Eberli D, Andersson KE, Yoo JJ, Atala A. A canine model of irreversible urethral sphincter insufficiency. BJU Int. 2009 Jan;103(2):248-53. doi: 10.1111/j.1464-410X.2008.08001.x. Epub 2008 Sep 8.

  PMID: 18782310 BACKGROUND

• MAURO A. Satellite cell of skeletal muscle fibers. J Biophys Biochem Cytol. 1961 Feb;9(2):493-5. doi: 10.1083/jcb.9.2.493. No abstract available.

  PMID: 13768451 BACKGROUND

• Benchaouir R, Rameau P, Decraene C, Dreyfus P, Israeli D, Pietu G, Danos O, Garcia L. Evidence for a resident subset of cells with SP phenotype in the C2C12 myogenic line: a tool to explore muscle stem cell biology. Exp Cell Res. 2004 Mar 10;294(1):254-68. doi: 10.1016/j.yexcr.2003.11.005.

  PMID: 14980519 BACKGROUND

• Partridge TA, Morgan JE, Coulton GR, Hoffman EP, Kunkel LM. Conversion of mdx myofibres from dystrophin-negative to -positive by injection of normal myoblasts. Nature. 1989 Jan 12;337(6203):176-9. doi: 10.1038/337176a0.

  PMID: 2643055 BACKGROUND

• Yiou R, Lefaucheur JP, Atala A. The regeneration process of the striated urethral sphincter involves activation of intrinsic satellite cells. Anat Embryol (Berl). 2003 May;206(6):429-35. doi: 10.1007/s00429-003-0313-x. Epub 2003 May 1.

  PMID: 12728313 BACKGROUND

• Gussoni E, Soneoka Y, Strickland CD, Buzney EA, Khan MK, Flint AF, Kunkel LM, Mulligan RC. Dystrophin expression in the mdx mouse restored by stem cell transplantation. Nature. 1999 Sep 23;401(6751):390-4. doi: 10.1038/43919.

  PMID: 10517639 BACKGROUND

• Leobon B, Garcin I, Menasche P, Vilquin JT, Audinat E, Charpak S. Myoblasts transplanted into rat infarcted myocardium are functionally isolated from their host. Proc Natl Acad Sci U S A. 2003 Jun 24;100(13):7808-11. doi: 10.1073/pnas.1232447100. Epub 2003 Jun 12.

  PMID: 12805561 BACKGROUND

• Seidel M, Borczynska A, Rozwadowska N, Kurpisz M. Cell-based therapy for heart failure: skeletal myoblasts. Cell Transplant. 2009;18(7):695-707. doi: 10.3727/096368909X470810. Epub 2009 Apr 6.

  PMID: 19500482 BACKGROUND

• Yiou R, Yoo JJ, Atala A. Restoration of functional motor units in a rat model of sphincter injury by muscle precursor cell autografts. Transplantation. 2003 Oct 15;76(7):1053-60. doi: 10.1097/01.TP.0000090396.71097.C2.

  PMID: 14557752 BACKGROUND

• Badra S, Andersson KE, Dean A, Mourad S, Williams JK. Long-term structural and functional effects of autologous muscle precursor cell therapy in a nonhuman primate model of urinary sphincter deficiency. J Urol. 2013 Nov;190(5):1938-45. doi: 10.1016/j.juro.2013.04.052. Epub 2013 Apr 22.

  PMID: 23618586 BACKGROUND

Study Officials

• Gary G Poehling, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary-Clare Day, RN

CONTACT

336-713-1343; mday@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 23, 2018
• Study Start: November 4, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)