Repeated Injections of Adipose-derived Stem Cells in Rotator Cuff Tears

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). We 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Injuries; Rotator Cuff Tears; Stem Cells
• Intervention / Treatment: Biological: Adipose derived stem cell injection

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, we 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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Stephanie Wej Andkjær; Phone Number: +4579970000; Email: stephanie.wej.andkjaer@rsyd.dk
• Study Contact Backup: Name: Lars Frich; Email: lars.henrik.frich@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single 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.	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.
Experimental: Triple 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Oxford Shoulder Score (OSS)	The Oxford Shoulder Score is a patient-reported 60-point max score of shoulder functionality and pain during activities of daily living	Baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Oxford Shoulder Score (OSS) at 3 months	The Oxford Shoulder Score is a patient-reported 60-point max score of shoulder functionality and pain during activities of daily living	Baseline and 3 months
Change in the Oxford Shoulder Score (OSS) at 6 months	The Oxford Shoulder Score is a patient-reported 60-point max score of shoulder functionality and pain during activities of daily living	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/depressio. This scale is numbered from 0 to 100. 100 = best health and 0 = worst health.	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/depressio. This scale is numbered from 0 to 100. 100 = best health and 0 = worst health.	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/depressio. This scale is numbered from 0 to 100. 100 = best health and 0 = worst health.	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	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	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	Baseline and 12 months
Change in infiltration with Goutallier at 6 months	Infiltration of muscle tissue by fat measured according to Goutallier klassification. 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	Baseline and 6 months
Change in infiltration with Goutallier at 12 months	Infiltration of muscle tissue by fat measured according to Goutallier klassification. 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	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	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	Baseline and 12 months

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Investigators: Principal Investigator: Lars Frich, Orthopedic research department, Hospital Sønderjylland

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ADSC; Adipose derived stem cells
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: SHS-Orto-2026-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No