NCT01832428Unknown1 期
A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke. It is Self Funded (Patients' Own Funding) Clinical Trial
Chaitanya Hospital, Pune2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Improvement in power of Body and facial Muscles
研究概览
简要总结
This study is single, centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face
详细描述
This study is single centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient should suffer from stroke due to cerebral infarct or Haemorrhage or accelerated hypertension.
- •willingness to undergo bone marrow derived autologous cell therapy.
- •patient those provide fully Informed consent form for the study.
- •Ability and willingness to regular visit to hospital and follow up during the protocol Procedure.
排除标准
- •Patients with pre - existing or Current systemic disease such as lung , liver ( exception; History of uncomplicated Hepatitis A),gastrointestinal, Cardiac , Immunodeficiency,(including HIV) Or laboratory Investigation that could cause a neurological defect.History of Life threating Allergic or immune- mediated reaction.
- •Alcohol and drug abuse / dependence.
- •Severe skin infection.
- •Haemodynamically unstable.
- •subject with primary and secondary diabetes , Insulin depenence,
结局指标
主要结局
Improvement in power of Body and facial Muscles
时间窗: 6 Months
Improvement in power of Body and facial Muscles.
次要结局
- Improvement in Walking Ability(6 months)
- Improvement In Speech and cognition(6 Months)
- Improvement in Vision in both eyes(6 month)
研究者
Dr. Sachin Jamadar
CO-Investigator
Chaitanya Hospital, Pune
研究点 (2)
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