Actively Recruiting
Long-Term Follow-Up Study to Evaluate Safety and Efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cells in Rotator Cuff Disease
Led by Seoul National University Hospital · Updated on 2026-05-22
21
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term safety and effectiveness of allogenic umbilical cord-derived mesenchymal stem cells in patients with rotator cuff disease. The study focuses on monitoring outcomes decades after initial treatment to understand the lasting impact of this therapy. Participants are those who previously received this investigational stem cell treatment in an earlier phase 1/2a trial. This open-label, single-center study involves a long-term follow-up period extending up to 60 months where patients are observed and evaluated without additional new treatments being administered. During the follow-up, researchers will assess shoulder pain and disability using the Shoulder Pain and Disability Index (SPADI) score and other measures like the Constant-Murley score and Visual Analog Scale pain during motion. Imaging tests such as MRI will monitor changes in rotator cuff tear size, and any adverse events will be recorded. Participation involves periodic assessments over a five-year period ending in 2032, with safety and efficacy carefully tracked.
CONDITIONS
Brief Title
Long-Term Follow-up Study to Evaluate Long-Term Safety and Efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients With Rotator Cuff Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Received the investigational medicinal product in the Phase 1/2a clinical trial (ASB-IP-001)
- Voluntarily agreed to participate in this long-term follow-up study and provided written informed consent
You will not qualify if you...
- Cannot be contacted by telephone, mail, or e-mail, making follow-up assessment impossible
- Deemed inappropriate for participation by the investigator, including cases posing significant health or safety risk
- Cases where follow-up visits or assessments are practically impossible due to cognitive impairment or communication difficulties
- Cases unlikely to continue follow-up due to difficulty adhering to the study schedule (e.g., prolonged hospitalization, long-term residence abroad)
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.
1 visit (in-person)
Duration - Up to 60 months
Participants who previously received the investigational product are followed over time to assess long-term safety and efficacy.
Visits scheduled over 60 months for follow-up assessments
Trial Site Locations
Total: 1 location
1
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, Korea, South Korea, 07061
Actively Recruiting
Research Team
K
KeeJeong Bae, Principal Investigator
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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