Rotator Cuff TearsPhase 1/2NCT07592936
Repeated Injections of Adipose-derived Stem Cells in Rotator Cuff Tears
A Phase 1/2 study testing Adipose derived stem cell injection in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by University of Southern Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries, Stem Cells
- What is being tested?
- Adipose derived stem cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- No history of inflammatory disease
- Negative infectious disease marker tests Signed consent to the study
Who cannot join
- 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
- Previous radiotherapy to the shoulder
- BMI under 18
Show all 9Show fewer
- BMI above 35
- Allergy to antibiotics such as penicillin
- Coagulopathy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lars Frich contact
About this study
Official title: Effects and Benefits of Repeated Injections of Adipose-derived Stem Cells on Shoulder Function in Rotator Cuff Tears: A Randomized Controlled Study
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.
Read the detailed description
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.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries, Stem Cells
- Being tested
- Adipose derived stem cell injection, Placebo
- Keywords
- Adipose derived stem cells, ADSC
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose derived stem cell injectionBiological
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.
PlaceboBiological
Standard care
| Study group | Role | What they receive |
|---|---|---|
| Single injection | Placebo comparator | Standard surgical reconstruction of rotator cuff tear, following the local guidelines of Hospital Sonderjylland Receives: Biological: Placebo |
| Triple injection | Experimental | 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. Receives: Biological: Adipose derived stem cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 12 months
Secondary outcomes (17)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Frich, Principal investigator, Orthopedic research department, Hospital Sønderjylland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592936
- Sponsor's protocol ID
- SHS-Orto-2026-1
- Status last verified
- Jun 2026
- First submitted
- 11 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Benefits of Repeated Injections of Adipose-derived Stem Cells on Shoulder Function in Rotator Cuff Tears: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07592936
- Acronym / sponsor ID
- SHS-Orto-2026-1
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries, Stem Cells
- Keywords
- Adipose derived stem cells, ADSC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single injection | Placebo comparator | Biological: PlaceboStandard surgical reconstruction of rotator cuff tear, following the local guidelines of Hospital Sonderjylland |
| Triple injection | Experimental | Biological: Adipose derived stem cell injectionDuring 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. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- No history of inflammatory disease
Key exclusion criteria (9 listed)
- 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
- Previous radiotherapy to the shoulder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose derived stem cell injectionA 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. | Biological | Triple injection |
| PlaceboStandard care | Biological | Single injection |
Primary outcome
Change in the Oxford Shoulder Score (OSS)
Time frame: Baseline and 12 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).
17 secondary outcomes
Change in the Oxford Shoulder Score (OSS) at 3 months
Time frame: Baseline and 3 months
Change in the Oxford Shoulder Score (OSS) at 6 months
Time frame: Baseline and 6 months
Change in Quality of Life at 3 months
Time frame: Baseline and 3 months
Change in Quality of Life at 6 months
Time frame: Baseline and 6 months
Change in Quality of Life at 12 months
Time frame: Baseline and 12 months
Change in Radiological healing at 3 months
Time frame: Baseline and 3 months
Change in Radiological healing at 6 months
Time frame: Baseline and 6 months
Change in Radiological healing at 12 months
Time frame: Baseline and 12 months
Change in infiltration with Goutallier at 6 months
Time frame: Baseline and 6 months
Change in infiltration with Goutallier at 12 months
Time frame: Baseline and 12 months
Change in infiltration with Fuchs at 6 months
Time frame: Baseline and 6 months
Change in infiltration with Fuchs at 12 months
Time frame: Baseline and 12 months
Change in the range of pain free movement at 3 months
Time frame: Baseline and 3 months
Change in the range of pain free movement at 6 months
Time frame: Baseline and 6 months
Change in the range of pain free movement at 12 months
Time frame: Baseline and 12 months
Change in muscle contraction at 6 months
Time frame: Baseline and 6 months
Change in muscle contraction at 12 months
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lars Frich contact
Lars Frich principal investigator
Orthopedic research department, Hospital Sønderjylland
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adipose derived stem cell injection in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by University of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Wej Andkjær (+4579970000, stephanie.wej.andkjaer@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Oxford Shoulder Score (OSS) (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.