RecruitingNCT07374679

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

A Single Center, Open Label, 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


Sponsor

Seoul National University Hospital

Enrollment

21 participants

Start Date

Jan 27, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 19 Years

Inclusion Criteria2

  • 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 Criteria3

  • 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).

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Locations(1)

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

Seoul, Korea, South Korea

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NCT07374679


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