Actively Recruiting
Arthroscopic Rotator Cuff Repair with Umbilical Cord-derived Mesenchymal Stem Cells for Large to Massive Rotator Cuff Tears
Led by Korea University Anam Hospital · Updated on 2025-02-18
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Arthroscopic Rotator Cuff Repair with UC-MSCs for Large to Massive Tears
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 19 years of age and older
- Unilateral shoulder pain with a pain score of 4 or higher
- Symptoms lasting at least three months without improvement from conventional treatments including analgesics
- Diagnosed with massive or extensive full-thickness rotator cuff tears confirmed by CT arthrography or MRI
You will not qualify if you...
- Diagnosed with small or medium full-thickness rotator cuff tears
- Received subacromial injection therapy in the affected shoulder within the past three months
- Underwent rotator cuff surgery on the affected shoulder within the past six months
- Radiological findings of malignant tumors, severe glenohumeral osteoarthritis, or bony abnormalities causing subacromial space narrowing
- Symptomatic cervical spine disorders
- Bilateral shoulder pain
- Diagnosed with multiple arthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia
- Neurological deficits
- Pregnant or breastfeeding
- Unwilling to use effective contraception during the study
- Currently infected with HBV, HCV, or HIV, or positive RPR test
- Severe conditions affecting the study including cardiovascular, renal, hepatic, endocrine diseases, or malignancies
- Unable to understand study questionnaires or with communication difficulties due to psychiatric disorders
- Any other cases deemed inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure with immediate post-operative care
Participants undergo arthroscopic rotator cuff repair surgery combined with an injection of allogenic Umbilical Cord-derived Mesenchymal Stem Cells into the lesion.
1 surgical and injection visit (in-person)
Duration - Up to 12 months
Participants are monitored for recovery, pain levels, and changes in rotator cuff tear size using MRI, including assessment of adverse events.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Korea University Anamh Hospital
Seoul, Korea, South Korea, 02841
Actively Recruiting
Research Team
W
Woong Kyo Jeong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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