Arthroscopic Rotator Cuff Repair Using Umbilical Cord-Derived Mesenchymal Stem Cells for Large and Massive Rotator Cuff Tears

What this Trial Is About

This research aims to evaluate the safety of using allogeneic umbilical cord-derived mesenchymal stem cells in patients undergoing arthroscopic rotator cuff repair for large to massive rotator cuff tears. It focuses on adults aged 19 and older who have significant shoulder pain and full-thickness tears that have not improved with conventional treatments. The study is sponsored by Korea University Anam Hospital and is designed to assess pain and tissue healing over a year. Participants receive a single injection of allogeneic umbilical cord-derived mesenchymal stem cells during their rotator cuff repair surgery. Two dosing options are studied a low dose of 2.5x10 cells in 0.5 mL and a high dose of 5x10 cells in 1 mL. The injection is performed into the lesion using ultrasound guidance by the investigator. This treatment is given only once during the study period. Throughout the 12 months following treatment, participants will be monitored for pain during movement using the Visual Analog Scale VAS and changes in the size of their rotator cuff tears through MRI scans. Adverse events will also be tracked to assess safety. Participants will complete questionnaires and attend regular follow-up visits during the study. The total duration of participation spans one year from the intervention.

Arthroscopic Rotator Cuff Repair with UC-MSCs for Large to Massive Tears