Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Diabetes Mellitus. It is Self Funded (Patients' Own Funding) Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Abolition or reduction of insulin by >50 percentage
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 mono nuclear cells (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are abolition or reduction of insulin by>50 percentage by the end of 6 months of ABMSCT-Any reduction in requirement of Insulin dosage and Improvement in HbA1C Level.
详细描述
his study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mono nuclear cells (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are abolition or reduction of insulin by>50 percentage by the end of 6 months of ABMSCT-Any reduction in requirement of Insulin dosage and Improvement in HbA1C Level.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient should suffer from Diabetes Mellitus.
- •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 ,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. Patients with History of Hypertension and Hypersensitive.
研究组 & 干预措施
Transfer of autologous MNC intrathecally
single arm Intra thecal transplantation of autologous MNC
干预措施: Intra thecal transplantation of autologous MNC (Other)
结局指标
主要结局
Abolition or reduction of insulin by >50 percentage
时间窗: 6 months
\- Abolition or reduction of insulin by \>50 percentage of ABMSCT by 6 month
次要结局
- Improvement in HbA1C levels(6 months)
研究者
Dr. Sachin Jamadar
CO-Investigator
Chaitanya Hospital, Pune