NCT07605559尚未招募不适用
A Multi-center Study on Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears
Kyoung Hwan Koh1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2026年5月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate umbilical cord-derived mesenchymal stem cell injectables for the regeneration of partial-thickness rotator cuff tears
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Adults aged 19 years or older
- •Shoulder pain lasting for at least 3 months
- •A pain visual analogue scale (VAS) score of 4 or greater
- •Inadequate response to sufficient conservative treatment for at least 3 months, such as medication, injection therapy, physical therapy, or exercise therapy
- •Partial-thickness rotator cuff tear confirmed by ultrasonography or magnetic resonance imaging (MRI)
- •No restrictions on participation in clinical trial procedures, including hospitalization
排除标准
- •Receipt of subacromial injection therapy in the affected shoulder within the past 3 months
- •History of rotator cuff surgery on the affected shoulder within the past 6 months
- •Previous treatment with a stem cell therapy for the shoulder
- •Presence of any of the following shoulder conditions: full-thickness rotator cuff tear, obvious isolated acromioclavicular joint arthropathy, or a clear history of trauma to the shoulder joint within the past 3 months
- •Radiologic findings suggestive of or consistent with any of the following: malignancy, severe glenohumeral osteoarthritis, bony abnormalities causing narrowing of the subacromial space, or clear evidence of acute traumatic rotator cuff injury
- •Presence of symptomatic cervical spine disease
- •Patients with polyarthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia
- •Clinical trial subjects with neurological deficits
- •Pregnant or breastfeeding women
- •Unwillingness to use an effective method of contraception during participation in the clinical trial
- •Presence of any serious disease that may affect participation in this clinical trial, including cardiovascular, renal, hepatic, endocrine, or neoplastic disease
- •Inability to understand the questions used to assess the subject's condition, including the visual analogue scale (VAS), or communication difficulties due to psychiatric illness
- •Unwillingness to participate in the clinical trial or difficulty in complying with follow-up visits according to the study schedule
- •Participation in another clinical trial within 3 months prior to enrollment in this clinical trial
- •Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical trial
研究者
Kyoung Hwan Koh
Principal Investigator
Asan Medical Center
研究点 (1)
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