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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fat Free Muscle Volume | Fat-free muscle volume (total muscle volume minus % of fatty infiltration). | Month 1, Month 6, and Month 12 |
| Goutallier Score via MRI 1.5+ image analysis | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary-Clare Day, RN | Contact | 336-713-1343 | mday@wakehealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gary G Poehling, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24845686 | Background | 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. | |
| 22236637 | 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. |
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|
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| 12 weeks, 6 months, and 12 months post operatively |
| Constant Score | 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. | 12 weeks, 6 months, and 12 months post operatively |
| ASES Shoulder Score | 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. | 12 weeks, 6 months, and 12 months post operatively |
| Dynamometer measurements | 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. | 12 weeks, 6 months, and 12 months post operatively |
| 18782310 | 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. |
| 13768451 | 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. |
| 14980519 | 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. |
| 2643055 | 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. |
| 12728313 | 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. |
| 10517639 | 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. |
| 12805561 | 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. |
| 19500482 | 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. |
| 14557752 | 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. |
| 23618586 | 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. |