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

Seoul National University

Status: Not yet enrolling

Conditions: Rotator Cuff Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07374679

ASB-LTFUP-001

Details and patient eligibility

About

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

Enrollment: 21 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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).

Trial design

21 participants in 1 patient group

Long-term Follow-up Cohort