A Phase 1/2 interventional study of Adipose derived stem cell injection and Placebo in Rotator Cuff Tears, Rotator Cuff Injuries and Stem Cells, sponsored by University of Southern Denmark. Not yet recruiting. Open to participants aged 30 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by University of Southern Denmark · Phase 1/2, Interventional, and Treatment
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.
Treatment of RCTs with micro-fragmented adipose tissue is a minimal invasive procedure with the potential to shorten recovery, accelerate return to daily activity and work and improve functional outcomes compared to conventional surgery alone.
This study will provide evidence on whether three MFAT injections can augment conventional rotator cuff tear treatment. It will also assess the feasibility of implementing this treatment as part of standard care, given its potential for easy standardization. In addition to offering a novel therapeutic approach, the project will correlate functional outcomes with data from muscle biopsies, phenotypic composition of the implanted cells, imaging modalities, and patient reported outcomes. This study will generate critical new knowledge and serve as a cornerstone for the development of precision regenerative medicine in shoulder pathology. By elucidating patient-specific biological responses and therapeutic outcomes, the investigators aim to advance personalized treatment strategies for rotator cuff tears. Building on these findings, we aim to launch a clinical trial to further validate precision medicine as a standard therapeutic approach for patients suffering from rotator cuff tears.
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.
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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.
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.
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.
Standard surgical reconstruction of rotator cuff tear, following the local guidelines of Hospital Sonderjylland
Biological: Placebo
During the surgery a total of 5 mL of the stem cell suspension is injected into the supraspinatus muscle at three predefined sites located at the musculotendinous junction. For each site, 1.5-2.0 mL of the suspension is administered using an 18-gauge syringe. The stem cell treatment will be repeated at week 4 og 8 post operatively in an outpatient clinic. The injection will be performed under sterile conditions, local anesthesia, and guided by ultrasound to locate the musculotendinous junction of the supraspinatus muscle. Adipose derived stem cell injections for the triple injection will be repeated at 4 and 8 weeks postoperatively. These follow-up treatments will be performed in an outpatient clinic.
Biological: Adipose derived stem cell injection
A total of 5 mL of the stem cell suspension is injected into the supraspinatus muscle at three predefined sites located at the musculotendinous junction. For each site, 1.5-2.0 mL of the suspension is administered using an 18-gauge syringe. Adipose derived stem cell injections for the triple injection will be repeated at 4 and 8 weeks postoperatively. These follow-up treatments will be performed in an outpatient clinic.
Standard care
Change in the Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) is a 12-item, patient-reported questionnaire designed to measure pain and functional impairment in patients with shoulder pain. It assesses symptoms over the past four weeks, with a modified scoring method (0-4 per question) totaling 0-48 (48 being the best, 0, worst).
Time frame: Baseline and 12 months
Change in the Oxford Shoulder Score (OSS) at 3 months
The Oxford Shoulder Score (OSS) is a 12-item, patient-reported questionnaire designed to measure pain and functional impairment in patients with shoulder pain. It assesses symptoms over the past four weeks, with a modified scoring method (0-4 per question) totaling 0-48 (48 being the best, 0, worst).
Time frame: Baseline and 3 months
Change in the Oxford Shoulder Score (OSS) at 6 months
The Oxford Shoulder Score (OSS) is a 12-item, patient-reported questionnaire designed to measure pain and functional impairment in patients with shoulder pain. It assesses symptoms over the past four weeks, with a modified scoring method (0-4 per question) totaling 0-48 (48 being the best, 0, worst).
Time frame: Baseline and 6 months
Change in Quality of Life at 3 months
Quality of life will be measured using the EQ5D questionaire, a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This scale is numbered from 0 to 100. 100 = best health and 0 = worst health.
Time frame: Baseline and 3 months
Change in Quality of Life at 6 months
Quality of life will be measured using the EQ5D questionaire, a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This scale is numbered from 0 to 100. 100 = best health and 0 = worst health.
Time frame: Baseline and 6 months
Change in Quality of Life at 12 months
Quality of life will be measured using the EQ5D questionaire, a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This scale is numbered from 0 to 100. 100 = best health and 0 = worst health.
Time frame: Baseline and 12 months
Change in Radiological healing at 3 months
Defined as the distance between the bone and the tendon (distance of the gap) measured in millimeters. Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments.
Time frame: Baseline and 3 months
Change in Radiological healing at 6 months
Defined as the distance between the bone and the tendon (distance of the gap) measured in millimeters. Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments.
Time frame: Baseline and 6 months
Change in Radiological healing at 12 months
Defined as the distance between the bone and the tendon (distance of the gap) measured in millimeters. Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments.
Time frame: Baseline and 12 months
Change in infiltration with Goutallier at 6 months
Infiltration of muscle tissue by fat measured according to Goutallier classification. This classification is a five grade scale. Grade 0: normal muscle Grade 1: Some fatty streaks Grade 2: Less than 50% fatty muscle atrophy Grade 3: 50% muscle atrophy Grade 4: More than 50% fatty muscle atrophy
Time frame: Baseline and 6 months
Change in infiltration with Goutallier at 12 months
Infiltration of muscle tissue by fat measured according to Goutallier classification. This classification is a five grade scale. Grade 0: normal muscle Grade 1: Some fatty streaks Grade 2: Less than 50% fatty muscle atrophy Grade 3: 50% muscle atrophy Grade 4: More than 50% fatty muscle atrophy
Time frame: Baseline and 12 months
Change in infiltration with Fuchs at 6 months
Infiltration of muscle tissue by fat measured according to Fuchs classification. This classification is a three grade scale. Grade 0: normal muscle or some fatty streaks Grade 1: less than 50% fatty muscle atrophy Grade 2: 50% or more muscle atrophy
Time frame: Baseline and 6 months
Change in infiltration with Fuchs at 12 months
Infiltration of muscle tissue by fat measured according to Fuchs classification. This classification is a three grade scale. Grade 0: normal muscle or some fatty streaks Grade 1: less than 50% fatty muscle atrophy Grade 2: 50% or more muscle atrophy
Time frame: Baseline and 12 months
Change in the range of pain free movement at 3 months
Clinical healing is defined as pain-free movement about shoulder level, clinically measured by an experienced physician post surgery by the use of strength test equipment. The strength is measured against resistance and in kilos from the arm in a horizontal plane anterior to the patient
Time frame: Baseline and 3 months
Change in the range of pain free movement at 6 months
Clinical healing is defined as pain-free movement about shoulder level, clinically measured by an experienced physician post surgery by the use of strength test equipment. The strength is measured against resistance and in kilos from the arm in a horizontal plane anterior to the patient
Time frame: Baseline and 6 months
Change in the range of pain free movement at 12 months
Clinical healing is defined as pain-free movement about shoulder level, clinically measured by an experienced physician post surgery by the use of strength test equipment. The strength is measured against resistance and in kilos from the arm in a horizontal plane anterior to the patient
Time frame: Baseline and 12 months
Change in muscle contraction at 6 months
Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments. The measurement will be recorded during gradual, controlled loading
Time frame: Baseline and 6 months
Change in muscle contraction at 12 months
Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments. The measurement will be recorded during gradual, controlled loading
Time frame: Baseline and 12 months
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Aug 2028, 22 months later.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Sep 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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