临床试验/NCT02245711

NCT02245711撤回1 期

Intrathecal Autologous Mononuclear Cell Therapy for Limb Girdle Muscular Dystrophy

Neurogen Brain and Spine Institute2 个研究点分布在 1 个国家开始时间: 2010年12月最近更新: 2018年10月25日

适应症

干预措施

试验速览

阶段: 1 期
状态: 撤回
发起方: Neurogen Brain and Spine Institute
试验地点: 2
主要终点: Change in Functional Independence Measure (FIM) scale

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study was to study the effect of stem cell therapy on Limb Girdle Muscular Dystrophy patients.

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: 15 Years 至 60 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•age group of 15 years-60 years
•limb girdle muscular dystrophy diagnosed on the basis of clinical presentation
•Electromyographic and Nerve Conduction velocity findings

排除标准

•presence of respiratory distress
•presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
•malignancies
•acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction < 30%
•pregnancy or breastfeeding

研究组 & 干预措施

Stem Cell

Experimental

干预措施: Stem Cell (Biological)

结局指标

主要结局

Change in Functional Independence Measure (FIM) scale

时间窗: 1 year

Functional Independence Measure scale assesses the patients ability to carry out activities of daily living. At the follow up of 1 year, every patient in this study will be reevaluated on this scale.

次要结局

Change in Manual Muscle Testing (MMT)(1 year)

研究者

发起方

Neurogen Brain and Spine Institute

申办方类型

Other

责任方

Sponsor

研究点 (2)

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