Safety and Efficacy of Bone Marrow Derived MNCs for the Treatment of Huntingtons Chorea. It is Self Funded (Patients' Own Funding) Clinical Trial
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 Cognitive and psychiatric symptoms
研究概览
简要总结
This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cell {MNC} (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.
详细描述
This study is Single arm, Single Centre trial study the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cells (MNCs) ,to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.
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
- 35 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient should suffer from Hunting tons Chorea,
- •Hunting tons chorea commonly become noticeable between the ages of 35 -44
- •Willingness to undergo Bone Marrow derived Autologous cell Therapy.
- •Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study.
- •Ability and willingness to regular visit to hospital for protocol procedures and follow up
排除标准
- •Patient with History of Immunodeficiency HIV+,Hepatitis B virus ( HBV) and History of Life threatening allergic or immune -Mediated Reaction. the site of bone marrow aspiration potentially limiting Procedure.
- •alcohol and drug abuse / dependence.
- •Severe skin infection.
- •Haemodynamically unstable.
- •=subject with primary and secondary diabetes , Insulin dependence.
- •Neurological disease caused by autoimmune or genetic cause.
- •patients suffering from peripheral muscular dystrophy.
结局指标
主要结局
Improvement in Cognitive and psychiatric symptoms
时间窗: 6 Months
次要结局
- Improvement in writhing motions or abnormal posturing(6 month)
- Improvement in neuropsychiatric behaviour(6 Months)
- Increase in life expectancy(6 Months)
- Improvement in compulsive behaviour(6 month)
研究者
Dr. Sachin Jamadar
CO-Investigator
Chaitanya Hospital, Pune