NCT02474342已完成不适用
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Rotator Cuff Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- SPADI(Shoulder pain and disability index)Score
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells injection in patient with Rotator Cuff disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female 19 years of age and older.
- •Patients who have unilateral shoulder pain.
- •Patients who have had pain at least for 3 months and do not respond to conservative treatment.
- •Patients who have a partial-thickness rotator cuff tear confirmed with magnetic resonance imaging (MRI) or ultrasonography (US).
排除标准
- •Participants who met a single condition were excluded from the study
- •Patients who received any drug by subacromial injection for treatment within 3 months prior to this enrollment.
- •Patients who have a history of shoulder trauma including dislocation, subluxation, and fracture, breast cancer, or surgery around shoulder, neck and upper back within 6 months prior to this enrollment.
- •Patients who have a full-thickness rotator cuff tear
- •Patients who have radiological findings of malignancy, osteoarthritis of the glenohumeral joint, and skeletal abnormalities decreasing the subacromial space
- •Patients with symptomatic cervical spine disorders
- •Patients with concurrent bilateral shoulder pain
- •Patients with adhesive capsulitis, acromioclavicular arthropathy, polyarthritis, infectious arthritis, rheumatoid arthritis or diagnosed fibromyalgia
- •Patients with neurological deficit
- •Pregnant women or lactating mothers
- •Fertile woman of childbearing potential not willing to use adequate contraception for the study duration
- •Patients taking anticoagulants
- •Patients who are positive serology for human immunodeficiency (HIV), hepatitis B (HBV) or hepatitis C (HCV) and syphilis
- •Patients with serious condition which can affect this study such as severe cardiovascular diseases, renal diseases, liver diseases, endocrine diseases, and cancers
- •Patients who are difficulty participating in data collection due to communication problem and serious mental illness
- •Patients are unable to come into the clinic for regular follow-up
- •Patients who had participated in other clinical trials within 3 months prior to this study.
- •Patients who the principal investigator considered inappropriate for the clinical trial due to any other reasons than those listed above.
结局指标
主要结局
SPADI(Shoulder pain and disability index)Score
时间窗: 24 weeks
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.
次要结局
- Visual Analog Scale_pain in motion(24 weeks)
- Constant-Murley score(24 weeks)
- Adverse event(24weeks)
- Changes in the size of rotator cuff tears determined by arthroscopy(24 weeks)
- Changes in the size of rotator cuff tears determined by MRI(24 weeks)
研究者
Hyunchul Jo
Associate Professor, SMG-SNU Boramae Medical Center
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's DiseaseBuerger's DiseaseNCT01302015R-Bio15
已完成
不适用
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral HeadAvascular Necrosis of the Femoral HeadNCT01643655R-Bio15
已完成
1 期
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative ArthritisDegenerative ArthritisNCT01300598R-Bio18
撤回
不适用
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc DegenerationLumbar Intervertebral Disc DegenerationNCT01643681R-Bio
Unknown
不适用
Treatment of Early Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem CellsKnee OsteoarthritisNCT03956719Qilu Hospital of Shandong University8