Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study) (NCT06505135) | Clinical Trial Compass
By InvitationPhase 1
Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)
Denmark30 participantsStarted 2024-09-03
Plain-language summary
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.
Who can participate
Age range
40 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (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)
Exclusion Criteria
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient reported outcome of Oxford shoulder score
Timeframe: From inclusion and until 12 months after operation