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Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients with Rotator Cuff Disease
Sponsor: Seoul National University Hospital
Summary
The purpose of this study is to evaluate safety and efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease
Official title: A Single Center, Open Label, Phase 1/2a Study to Evaluate Safety and Exploratory Efficacy of Allogenic Umbilical Cord Derived Mesenchymal Stem Cell Treatment in Patients with Rotator Cuff Disease
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2025-01-17
Completion Date
2027-01
Last Updated
2025-02-04
Healthy Volunteers
No
Conditions
Interventions
Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell
Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Low dose: 1x10⁷ cells/3mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Mid dose: 5x10⁷ cells/3mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * High dose: 1x10e8 cells/3mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator
Locations (1)
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, Korea, South Korea