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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Shoulder pain and disability index(SPADI) Score
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Long-term Follow-up Cohort
结局指标
主要结局
Shoulder pain and disability index(SPADI) Score
时间窗: 60months
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The minimum value is 0 and the maximum value is 10. "0" means no pain and "10" means the worst pain imaginable in the pain section. "0" means no difficulty and "10" means so difficult it requires help in the pain section.
次要结局
- Constant-Murley score(60 months)
- Visual Analog Scale(VAS) pain in motion(60 months)
- Changes in the size of rotator cuff tears determined by MRI(60 months)
- Adverse event(60 months)