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 groups

Locations

This trial has no locations

Sponsors and collaborators

University of Southern Denmark

Lead sponsor