Repeated Injections of Adipose-derived Stem Cells in Rotator Cuff Tears
NCT07592936 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-18
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). We 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.
Conditions
- Rotator Cuff Tears
- Rotator Cuff Injuries
- Stem Cells
Interventions
- 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. Adipose 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.
Sponsors & Collaborators
-
University of Southern Denmark
lead OTHER
Principal Investigators
-
Lars Frich · Orthopedic research department, Hospital Sønderjylland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2028-08-31
- Completion
- 2028-08-31
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