Repeated Injections of Adipose-derived Stem Cells in Rotator Cuff Tears
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adipose derived stem cell injection, Placebo.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tears, Rotator Cuff Injuries, Stem Cells. Basic parameters: 30 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects and Benefits of Repeated Injections of Adipose-derived Stem Cells on Shoulder Function in Rotator Cuff Tears: A Randomized Controlled Study
Overview
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.
Interventions
- 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. - Biological Placebo
Standard care
Primary outcome measures
- Change in the Oxford Shoulder Score (OSS) [Time frame: Baseline and 12 months]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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 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
Exclusion criteria
- 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
- BMI above 35
- Allergy to antibiotics such as penicillin
- Coagulopathy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07592936 · SHS-Orto-2026-1