Repeated Injections of Adipose-derived Stem Cells in Rotator Cuff Tears
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age30-69
SponsorUniversity of Southern Denmark
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Adipose derived stem cell injection
- Placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov