Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)

PHASE1Enrolling by invitationINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 3, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Rotator Cuff TearsRotator Cuff InjuriesRotator Cuff Tear Arthropathy
Interventions
BIOLOGICAL

Stem-cell treatment

"In the cell treatment group of patients, injection of the cell suspension will be performed at the end of the surgical procedure. Fluid is carefully aspirated via the anterior outflow cannula, and autologous micro-fragmented adipose tissue is injected in dry arthroscopy conditions from the lateral portal while maintaining a subacromial view from the posterior portal.~10 mL of the stem cells suspension will be injected into the supraspinatus muscle at four predefined sites at the musculo-tendinous junction of the supraspinatus muscle. For each injection site, 1.5 mL of the suspension will be injected using an 18-gauge syringe."

OTHER

Standard care

Standard treatment also includes intravenous injection preoperatively of 2 g of Cloxacillin In case of allergy 1.5 g of Cefuroxim is chosen. Tendon suture is performed arthroscopically under regional anaesthetic blockage and light sedation with standard double row technique using suture anchors

Trial Locations (1)

6400

Orthopaedic Research Unit, Department of Orthopaedics, Hospital Sønderjylland, Region of Southern Denmark., Sønderborg

All Listed Sponsors
lead

University of Southern Denmark

OTHER