An observational study in Rotator Cuff Disease, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Seoul National University Hospital · Observational
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
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population consists of patients who previously received the investigational medicinal product in the Phase 1/2a clinical trial (ASB-IP-001) and who voluntarily agreed to participate in this long-term follow-up observational study by providing written informed consent. Participants are followed longitudinally to assess long-term safety and clinical outcomes, without any additional therapeutic intervention.
Exclusion Criteria:
Subjects deemed inappropriate for participation in this long-term follow-up study at the investigator's discretion, including:
Shoulder pain and disability index(SPADI) Score
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.
Time frame: 60months
Constant-Murley score
The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100.
Time frame: 60 months
Visual Analog Scale(VAS) pain in motion
Using a ruler, the score is determined by measuring the distance (mm) on the 100mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame: 60 months
Changes in the size of rotator cuff tears determined by MRI
Time frame: 60 months
Number of Participants with Adverse event
Adverse events will be collected from Visit 2 to Visit 6. The following information will be collected: adverse event term, start date/end date, adverse event category, severity of the adverse event, causal relationship with the investigational product, seriousness of the adverse event, and final outcome.
Time frame: 60 months
Plan to share: No
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Seoul National University Hospital