A Phase 1 interventional study of Stem-cell treatment and Standard care in Rotator Cuff Tears, Rotator Cuff Injuries and Rotator Cuff Tear Arthropathy, sponsored by University of Southern Denmark. Enrolling by invitation at 1 site in Denmark. Open to participants aged 40 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University of Southern Denmark · Phase 1, Interventional, and Treatment
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.
Damage to the tendons that stabilize the shoulder, particularly the supraspinatus tendon tear, has been recognized as the key lesion in rotator cuff tears. However, the lack of full functional recovery after surgical tendon reconstruction suggests that additional changes in the tissue are obstacles to rehabilitation. Recent studies demonstrate pathological changes in the supraspinatus muscle in animal models as a consequence of tendon tear. The muscle pathology includes muscle fibre atrophy, intracellular lipid accumulation, mitochondrial dysfunction, fibril disorganization, and reduced regenerative capacity. Moreover, fibrosis, accumulation of adipocytes, and inflammation develop in these muscles. Muscle strength is decreased by 30% several months after rotator cuff tear repair. Thus, the muscle becomes weaker and stiffer despite repair, suggesting that treatment of rotator cuff tear should include managing cuff muscle dysfunction.
Adipose derived cell therapy Muscle regeneration occurs in a specific environment to which several cell types contribute. The resident stem cell in skeletal muscle is the satellite cell. When skeletal muscle is damaged, the satellite cells are activated and start to proliferate to muscle repairing myoblast. Additional cell types support the regeneration by modulating the myoblast response, inflammation and vascularization. Skeletal muscle harbours a mesenchymal cell, the Fibro-Adipogenic Progenitor (FAP) cell. We have shown that FAPs respond to muscle damage, and is part of the muscle stem cell niche with supportive functions in muscle regeneration. This makes the use of FAPs or mesenchymal cells with a similar function derived from fat an interesting approach for muscle repair.
Implantation of various preparations of cell material that contain Mesenchymal Stromal Cells (MSC) have been used as therapy in a wide range of disorders including lesions in cardiac muscle. The most common sources of cells have been the bone marrow and adipose tissue, and the preparations have ranged from crude isolates of mononuclear cells, e.g. total stromal cells to more homogenous cultured cell isolates, that mainly contain MSC. Although these mesenchymal cells are able to differentiate into tissues such as bone and fat18, their major implication in tissue repair appears to be a capacity to support the regenerative milieu. Their known capacities include stimulation of tissue-specific cells like the myogenic cells, induction of vessel growth, and regulation of inflammation and apoptosis. Cells extracted from adipose tissue cells have shown a regenerative effect without major adverse effects when used as therapy in a range of tissue. Compared to skeletal muscle it is easier and less traumatic to obtain regenerative cells in a sufficient quantum from adipose tissue.
Production of cell preparations exclusively consisting of MSC requires isolation procedures and culturing for weeks, all of which has to be performed in certified laboratories. In case of homolog transplantation, the patient will have to have tissue harvested weeks before the operation. However, cell preparations enriched with MSC can be manufactured with simple, physical treatment of aspirated adipose tissue in a closed system. This can take place in the operation theatre within an hour. This means, that the preparation can be performed the same day as the implantation shall take place, in connection with the main operation.
The adipose tissue will be processed with cutting, grinding, and filtering - not to be considered as substantial manipulation. Likewise, the expected functions of the implanted, active cells in muscle are also found in adipose tissue, which is why the material probably not should be considered as engineered.
The material is derived from adipose tissue and will be used in skeletal muscle, and the use can in this respect be considered non-homologous. However, as the expected major functions in skeletal muscle are the same as in adipose tissue, the function may be accepted as homologous.
Therefore this trial treats patients in a one-day procedure. The adipose tissue will be harvested and processed as an initial procedure during surgery. At the end of the tendon suture procedure, the MSC enriched fragmented tissue will be injected into the supraspinatus muscle.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →University of Southern Denmark is the lead sponsor of 336 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ROTATOR CUFF SURGERY Rotator cuff tendon suture is carried out at Hospital Sønderjylland according to inclusion criteria. Standard treatment also includes intravenous injection preoperatively of 2 g of Cloxacillin In case of allergy 1.5 g of Cefuroxim is chosen. Tendon suture is performed arthroscopically under regional anaesthetic blockage and light sedation with standard double row technique using suture anchors.
Other: Standard care
HARVEST OF ADIPOSE TISSUE Harvest of adipose tissue from abdominal subcutis and the cell preparation will be performed in the approved lipoplasty system.This lipoaspirate will be processed in the dedicated adipose tissue-processing device. Cell clusters collected at the top of the adipose tissue-processing device undergo a second size reduction by being passed through a size reduction filter. The final product (approximately 60-100 mL) is then concentrated and collected into a 10-mL syringe for subsequent use. HARVEST OF MUSCLE BIOPSY FROM THE SUPRASPINATUS MUSCLE A biopsy of 0.1-0.2 g muscle is obtained from the supraspinatus muscle to estimate preoperative muscle fiber atrophy, intracellular lipid accumulation, mitochondrial dysfunction, inflammation and reduced regenerative capacity. The muscle biopsy specimens will be taken near the muscular tendinous junction during routine exposure or arthroscopy of the glenohumeral region.
Biological: Stem-cell treatment
In the cell treatment group of patients, injection of the cell suspension will be performed at the end of the surgical procedure. Fluid is carefully aspirated via the anterior outflow cannula, and autologous micro-fragmented adipose tissue is injected in dry arthroscopy conditions from the lateral portal while maintaining a subacromial view from the posterior portal. 10 mL of the stem cells suspension will be injected into the supraspinatus muscle at four predefined sites at the musculo-tendinous junction of the supraspinatus muscle. For each injection site, 1.5 mL of the suspension will be injected using an 18-gauge syringe.
Standard treatment also includes intravenous injection preoperatively of 2 g of Cloxacillin In case of allergy 1.5 g of Cefuroxim is chosen. Tendon suture is performed arthroscopically under regional anaesthetic blockage and light sedation with standard double row technique using suture anchors
Patient reported outcome of Oxford shoulder score
A difference in 8 points from the oxford shoulder score questionnaire. The Oxford Shoulder Score comprises twelve items: four assessing the degree of pain and eight evaluating function. Each item is rated on a 5-point Likert scale, where 0 indicates the worst outcome, and 4 indicates the best. The scores from these 12 items are summed to produce a total score ranging from 0 to 48
Time frame: From inclusion and until 12 months after operation
Clinical healing of the shoulder
Defined as pain-free movement above shoulder level
Time frame: 12 months post surgery
Radiological healing
Defined as closure of the gap between the tendon and the greater tuberosity that serves as the attachment for rotator cuff muscles assessed by MRI .
Time frame: baseline, 6 and 12 months post-surgery
Functioning of the supraspinatus muscle with improved muscle strain
Recorded be speckle tracking ultrasonography.
Time frame: baseline, 3, 6 and 12 months post-surgery
Oxford shoulder score
Difference in points measured by the oxford shoulder score
Time frame: baseline, 3, 6 and 12 months post-surgery
Quality of life (EQ5D)
Difference in points measured by EQ5D questionnaire. The EuroQol-5 Dimension (EQ-5D-5L): Improvements from the baseline in the EQ-5D-5L include self-rated health by a visual analog scale (VAS) measured by 3, 6, and 12 months. The EQ5D measures the quality of life on a 5-point Likert scale based on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, ranging from "no problems" to "extreme problems" . A key feature of the EQ-5D is the availability of "value sets" that weight the health states reported by patients into utility indexes according to the preferences of a country. For the Danish population, these values range from -0.757 to 1.0, where 1.0 corresponds to absolute health, 0 corresponds to death, and negative values correspond to a health status considered worse than death. The VAS scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.
Time frame: baseline, 3, 6 and 12 months post-surgery
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Southern Denmark →