Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below Years. It is Self Funded (Patients' Own Funding) Clinical Trial
试验速览
- 阶段
- 2 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 and overall motor control using oxford scale.
研究概览
简要总结
This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 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
This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject aged above 3 years and below 15 years with a diagnosis of Cerebral Palsy.
- •Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
- •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,meningoencephalits,epilepsy or life threatening allergic or immune -mediated reaction 2
- •Hemodynamically unstable patients
- •history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
- •peripheral Muscular dystropy
结局指标
主要结局
Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale.
时间窗: 6 months
- Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale at Time point - 6 Months.
次要结局
- -Improvement in IQ by using Benit Kamat scale.(6 Months)
研究者
Dr. Sachin Jamadar
CO-Investigator
Chaitanya Hospital, Pune