Long-Term Safety and Efficacy of Allogenic Umbilical Cord–Derived MSCs for Rotator Cuff Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational follow-up study tracks patients who previously received an investigational allogenic umbilical cord–derived mesenchymal stem cell therapy for rotator cuff disease. It aims to gather long-term safety and efficacy data over time. Eligible participants include those from a prior Phase 1/2a trial who consented to continued monitoring. The study relies on routine follow-up assessments to monitor health status and any lasting effects. Enrollment is limited to sites at major Seoul medical centers in Korea.

Why it matters

Who can join: the full rules

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).

Where it's running

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

Study contacts

• Study coordinator: KeeJeong Bae, Principal Investigator
• Email: grant903@gmail.com
• Phone: +82-10-5202-7469

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.