Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)

Enrolling by invitation · Phase 1

Conditions studied: Rotator Cuff Tears, Rotator Cuff Injuries, Rotator Cuff Tear Arthropathy

In brief

Treatment of rotator cuff tears with micro-fragmented adipose tissue is a minimal-invasive procedure with the potential to shorten and ease recovery, accelerate return to daily activity and work of thus with a potential capacity to improve the functional result compared to conventional surgery alone. The study will provide evidence whether the addition of micro-fragmented adipose tissue therapy can augment conventional rotator cuff tear treatment. The study will also reveal whether this treatment can be feasible for standard care of patients with rotator cuff tear as it will be simple to standardize. Moreover, besides providing a novel treatment for patients with rotator cuff tears, the project will based on data from muscle biopsies and scanning modalities, generate new knowledge, preparing for precision regenerative medicine in shoulder disease.

Key facts

Study ID

NCT06505135

Run by

University of Southern Denmark

People needed

30

Starts

2024-09-03

Expected to finish

2026-09-01

Last updated by the study team

2026-04-13

Who can join

Age: 40 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (out of 5) according to Fuchs et al. and based on Goutalliers classification
• No history of inflammatory disease
• ASA score < 3 (patients in good health)
• Signed consent to the study (including use of relevant data from the patient's electronic health records)

You may not qualify if…

• No MRI of the shoulder
• Former surgery in the affected shoulder
• Signs of infection
• Immunosuppression (due to clinical condition or medical therapy)
• History of inflammatory disease
• Malignancy within 5 years
• Previous radiotherapy to the shoulder
• BMI under 18
• BMI above 35
• Coagulopathy
• Non-Danish speaking patients

Where it is running

• Orthopaedic Research Unit, Department of Orthopaedics, Hospital Sønderjylland, Region of Southern Denmark. — Sønderborg, Danmark, Denmark

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.