[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100343468":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":50,"collaborators":30,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":30,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":30,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":34,"whyStopped":30,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: Muscle Fiber Fragments (MFFs)",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Muscle 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.",[9],[20],"Autologous",[22],{"name":23,"affiliation":5,"role":24},"Gary G Poehling, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Mary-Clare Day, RN","CONTACT","336-713-1343",null,"mday@wakehealth.edu",[33],{"facility":5,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Winston-Salem","North Carolina","27157","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-80.24422,36.09986,{"lat":44,"lon":43},[47,49],{"name":48,"role":28,"phone":29,"phoneExt":30,"email":31},"Mary-Claire Day, RN",{"name":23,"role":24,"phone":30,"phoneExt":30,"email":30},{"type":51,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100343468","muscle-fiber-fragments-for-improved-function-of-rotator-cuff-musculature-following-rotator-cuff-repair-100343468",false,"NCT03752034","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","Inclusion Criteria:\n\n* Males and females, ages 40 to 80 years\n* Unilateral Disease\n* \\\u003C 1.5cm tear\n\nExclusion Criteria:\n\n* Diabetes\n* Peripheral Neuropathy\n* Previous Shoulder Surgery\n* Pain Syndrome; cuff arthroplasty\n* Major co-morbidities including, but not limited to, uncontrolled diabetes, cardiovascular, pulmonary, GI, coagulopathies\n* Arthritis of Shoulder\n* Unwilling or unable to comply with post-operative instructions or follow-up visits\n* Auto Immune Disease\n* Complete Subscapularis Tear\n* Teres Minor involvement\n* History of testing positive for HIV, Hep B, Hep C, HTLV-1, HTLV-2\n* Pregnancy\n* Implanted devices containing ferromagnetic material\n* Any implanted electrical stimulation devices (i.e. cochlear implant, defibrillator)\n* Any other condition which the PI feels would be not in the best interest for the patient or the study","ALL","40 Years","80 Years",{"count":63,"type":64},20,"ESTIMATED","INTERVENTIONAL",[67],"NA","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).",[70],"Rotator Cuff",[72,73,74],"Muscle Fiber Fragments","Rotator Cuff Musculature","Rotator Cuff Repair","2026-03-26",{"date":77,"type":78},"2026-03-27","ACTUAL",{"date":80,"type":78},"2019-11-04",{"date":82,"type":64},"2027-12",{"name":5,"class":6},1]