Safety of Autologous Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 2/17/2019 |
| Start Date: | April 2019 |
| End Date: | January 2022 |
| Contact: | Mary-Clare Day, RN |
| Email: | mday@wakehealth.edu |
| Phone: | 336-713-1343 |
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).
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.
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.
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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Gary G Poehling, MD
Phone: 336-713-1343
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