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NCT07592936
Repeated Injections of Adipose-derived Stem Cells in Rotator Cuff Tears
Conditions: Rotator Cuff Tears, Rotator Cuff Injuries, Stem Cells
Sex: All
Ages: 30 Years – 69 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 30
Sponsor: University of Southern Denmark
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Clinical signs and symptoms compatible with a traumatic RCT
* MR verified supraspinatus tear
* Reparable lesion with tendon retraction \< 2 cm.
* Fatty infiltration level 0-2 according to Fuchs or out of 5 based on Goutalliers classification
* No history of inflammatory disease
* Negative infectious disease marker tests Signed consent to the study
Exclusion Criteria:
* Former surgery in the affected shoulder
* Signs of infection
* Immunosuppression (due to clinical condition or medical therapy)
* Any malignancy within 5 years prior to screening
* Previous radiotherapy to the shoulder
* BMI under 18
* BMI above 35
* Allergy to antibiotics such as penicillin
* Coagulopathy
Source: ClinicalTrials.gov (NCT07592936). StuddyBuddy aggregates publicly available trial information.