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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

Recruitingn/aAges 19 Years - anyAllSeoul National University Hospital
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
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; โ‘ก Cases in which long-term follow-up visits or assessments are practically impossible due to cognitive impairment, communication difficulties, or similar conditions; โ‘ข 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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What it tests

  • Not listed
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Where

1 site
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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