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

NCT07592936 | Not Yet Recruiting Phase 1

• 1 other identifier: SHS-Orto-2026-1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Rotator Cuff Tears; Stem Cells; Rotator Cuff Injuries

Keywords

Adipose derived stem cells; ADSC

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and 12 months

Secondary Outcomes (17)

• Change in the Oxford Shoulder Score (OSS) at 3 months

  Baseline and 3 months

• Change in the Oxford Shoulder Score (OSS) at 6 months

  Baseline and 6 months

• Change in Quality of Life at 3 months

  Baseline and 3 months

• Change in Quality of Life at 6 months

  Baseline and 6 months

• Change in Quality of Life at 12 months

  Baseline and 12 months

Study Arms (2)

Single injection

PLACEBO COMPARATOR

Standard surgical reconstruction of rotator cuff tear, following the local guidelines of Hospital Sonderjylland

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.

Biological: Adipose derived stem cell injection

Interventions

Placebo BIOLOGICAL

Standard care

Single injection

Adipose derived stem cell injection BIOLOGICAL

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.

Triple injection

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Lars Frich

  Orthopedic research department, Hospital Sønderjylland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Wej Andkjær

CONTACT

+4579970000; stephanie.wej.andkjaer@rsyd.dk

Lars Frich

CONTACT

lars.henrik.frich@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06