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

NCT07374679 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seoul National University Hospital

Phase

Observational

Started

2026-01-27

Last updated

2026-05-22

Condition(s) studied

Rotator Cuff Disease

Study summary

The purpose of this study is to evaluate Long-Term Safety and Efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Subjects who received the investigational medicinal product in the Phase 1/2a clinical trial (ASB-IP-001). * Subjects who voluntarily agreed to participate in this long-term follow-up study and provided written informed consent. Exclusion Criteria: * Subjects who cannot be contacted by any means, including telephone, mail, or e-mail, and for whom follow-up assessment is therefore not feasible. * Subjects deemed inappropriate for participation in this long-term follow-up study at the investigator's discretion, including: * Cases in which participation in the study may pose a significant risk to the subject's health or safety; ② Cases in which long-term follow-up visits or assessments are practically impossible due to cognitive impairment, communication difficulties, or similar conditions; ③ Cases in which continued participation in follow-up is unlikely due to difficulty adhering to the study schedule (e.g., prolonged hospitalization, long-term residence abroad).

Primary outcome measure(s)

Shoulder pain and disability index(SPADI) Score — 60months
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The minimum value is 0 and the maximum value is 10. "0" means no pain and "10" means the worst pain imaginable in the pain section. "0" means no difficulty and "10" means so difficult it requires help in the pain section.

Trial sites (1)

Facility	City	Region	Status
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine	Seoul	Korea	Recruiting

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Other trials for the same condition

Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients With Rotator Cuff Disease Recruiting

Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears Starting soon

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07374679 on ClinicalTrials.gov ↗ ← All trials in South Korea