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

Sponsor
University of Southern Denmark
Study ID
NCT07592936
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Rotator Cuff Injuries
  • Rotator Cuff Tears
  • Stem Cells

Eligibility Criteria

Sex
ALL
Age
30 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Placebo — BIOLOGICAL
    Standard care

Study Details

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.

Key Dates

First listed
May 18, 2026
Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Single injection
    Standard surgical reconstruction of rotator cuff tear, following the local guidelines of Hospital Sonderjylland
  • Experimental: Triple injection
    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.

Primary Outcome Measure

Change in the Oxford Shoulder Score (OSS) [ Time Frame: Baseline and 12 months ]

Central Contacts

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