Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Cerebral Palsy in Subjects Above Years (BMACCP) .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
- Improvement in muscle rigidity using Ash worth scale
研究概览
简要总结
This Study is Single arm, Single Centre trial to study the safety and efficacy of bone marrow derived autologous mononuclear cells (100 millions per dose)study enrollment duration 36 months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.
详细描述
Cerebral Palsy is commonest cause of Disability in India and south East Asia. This Study is devised to quantify the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose)study enrolment duration 36 months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy, in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern as per as various clinical scales and also changes in the brain.
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 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject aged above 15 years with a diagnosis of Cerebral Palsy. Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
- •Patient suffer from cerebral palsy due to prenatal and postnatal cause,
- •Willing to undergoing Bone Marrow derived autologous stem cell therapy.
- •Able to Comprehend and give written informed consent form for the study
- •willing to come to the hospital for follow up visits as per the protocol requirements
排除标准
- •History of meningitis,meningoencephalitis , epilepsy or life threatening allergic or immune -mediated reaction
- •Hemodynamically unstable patients
- •history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
- •peripheral Muscular dystrophy
结局指标
主要结局
Improvement in muscle rigidity using Ash worth scale
时间窗: 6 Months
次要结局
- Improvement in motor-linked implicit learning(6 month)
- Improvement in overall motor control using oxford scale(6 Months)
- Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour(6 month)
- Improvement in dysregulated phospholipid Metabolism(6 months)
- Improvement in walking ability and kinetic gait Pattern(6 Months)
研究者
Dr. Sachin Jamadar
CO-Investigator
Chaitanya Hospital, Pune