Recruiting NCT07374679
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Disease. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Primary outcome measures
- Shoulder pain and disability index(SPADI) Score [Time frame: 60months]
Secondary outcome measures (4)
- Constant-Murley score [Time frame: 60 months]
- Visual Analog Scale(VAS) pain in motion [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 [Time frame: 60 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Se — Seoul
Identifiers
NCT: NCT07374679 · ASB-LTFUP-001