[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642907":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":44,"collaborators":26,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":26,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":26,"studyType":59,"phases":60,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":26},{"fullName":5,"class":6},"University of Southern Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single injection","PLACEBO_COMPARATOR","Standard surgical reconstruction of rotator cuff tear, following the local guidelines of Hospital Sonderjylland",[13],"Biological: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Triple injection","EXPERIMENTAL","During the surgery a total of 5 mL of the stem cell suspension is injected into the supraspinatus muscle at three predefined sites located at the musculotendinous junction. For each site, 1.5-2.0 mL of the suspension is administered using an 18-gauge syringe. The stem cell treatment will be repeated at week 4 og 8 post operatively in an outpatient clinic. The injection will be performed under sterile conditions, local anesthesia, and guided by ultrasound to locate the musculotendinous junction of the supraspinatus muscle.\n\nAdipose derived stem cell injections for the triple injection will be repeated at 4 and 8 weeks postoperatively. These follow-up treatments will be performed in an outpatient clinic.",[19],"Biological: Adipose derived stem cell injection",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Adipose derived stem cell injection","A total of 5 mL of the stem cell suspension is injected into the supraspinatus muscle at three predefined sites located at the musculotendinous junction. For each site, 1.5-2.0 mL of the suspension is administered using an 18-gauge syringe.\n\nAdipose derived stem cell injections for the triple injection will be repeated at 4 and 8 weeks postoperatively. These follow-up treatments will be performed in an outpatient clinic.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Standard care",[9],[32],{"name":33,"affiliation":34,"role":35},"Lars Frich","Orthopedic research department, Hospital Sønderjylland","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Stephanie Wej Andkjær","CONTACT","+4579970000","stephanie.wej.andkjaer@rsyd.dk",{"name":33,"role":39,"phone":26,"phoneExt":26,"email":43},"lars.henrik.frich@rsyd.dk",{"type":45,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100642907","phase-1-repeated-injections-of-adipose-derived-stem-cells-in-rotator-cuff-tears-100642907",false,"NCT07592936","Repeated Injections of Adipose-derived Stem Cells in Rotator Cuff Tears","Effects and Benefits of Repeated Injections of Adipose-derived Stem Cells on Shoulder Function in Rotator Cuff Tears: A Randomized Controlled Study","Inclusion Criteria:\n\n* Clinical signs and symptoms compatible with a traumatic RCT\n* MR verified supraspinatus tear\n* Reparable lesion with tendon retraction \\\u003C 2 cm.\n* Fatty infiltration level 0-2 according to Fuchs or out of 5 based on Goutalliers classification\n* No history of inflammatory disease\n* Negative infectious disease marker tests Signed consent to the study\n\nExclusion Criteria:\n\n* Former surgery in the affected shoulder\n* Signs of infection\n* Immunosuppression (due to clinical condition or medical therapy)\n* Any malignancy within 5 years prior to screening\n* Previous radiotherapy to the shoulder\n* BMI under 18\n* BMI above 35\n* Allergy to antibiotics such as penicillin\n* Coagulopathy","ALL","30 Years","69 Years",{"count":57,"type":58},30,"ESTIMATED","INTERVENTIONAL",[61,62],"PHASE1","PHASE2","The aim of the project is to investigate whether repeated implantations of micro-fragmented adipose tissue (MFAT), into the shoulder muscle can improve the outcome of standard surgical treatment for rotator cuff tears (RCT). The investigators hypothesize that combining surgery with repeated implantations of micro-fragmented adipose tissue (MFAT) into the muscle provides a more effective treatment for patients with rotator cuff tears compared to standard surgical treatment. The result would be better outcomes such as improved shoulder functioning and reduced pain.",[65,66,67],"Rotator Cuff Tears","Rotator Cuff Injuries","Stem Cells",[69,70],"Adipose derived stem cells","ADSC","NOT_YET_RECRUITING","2026-06-09",{"date":74,"type":75},"2026-06-12","ACTUAL",{"date":77,"type":58},"2026-08",{"date":79,"type":58},"2028-08",{"name":5,"class":6}]