To Study the Safety and Efficacy of Autologous Bone Marrow Derived Mononuclear Cell Transplant in the Management of Various Neurological Disorders
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To evaluate the safety and to assess the efficacy of autologous bone marrow-derived mononuclear cell therapy in improving neurological function.
研究概览
简要总结
Neurological disorders encompass a wide range of conditions that affect the brain, spinal cord, and nerves throughout the body and includes illnesses like cerebral palsy, spinal cord injuries, and muscular dystrophy, that currently have no known definitive treatments or cures. With their capacity to differentiate into diverse cell lineages, immunomodulatory attributes, and paracrine actions, therapeutic MNCs hold great promise for the treatment of neurological disorders and being autologous have the additional benefit of being safe.
Objectives: To evaluate safety and efficacy of autologous BM-MNCs and their impact on quality of life in patients with neurological disorders.
200 patients of neurological disorders, will be included in study and each Individual will be injected MNCs intrathecally and/or intramuscularly which will be obtained from the patient’s own blood marrow. 3 such cycles of autologous BM-MNCs will be administered at an interval of 3 months with a mean follow up of 15 ± 1 months from the baseline**.**
Autologous MNCs administration, intrathecally as well as intramuscularly can prove to be a safe and efficacious treatment option that produces functional improvements in incurable neurological diseases and hence, a new hope for these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with established clinical diagnosis of Cerebral Palsy, Spinal cord injury, Muscular dystrophy or other neurological disorders for whom there were no proven interventions available or if available had been ineffective.
排除标准
- •Patients with organic brain disorders, Hydrocephalus, CNS Infection, space occupying lesions Presence of acute infections such as HIV/HBV/ HCV; malignancies, and any other medical conditions such as respiratory infection, cardiac conditions Patients who are unlikely to adhere to follow-up visits or those who cannot commit to the required follow-up duration Patients not giving consent for procedure  .
结局指标
主要结局
To evaluate the safety and to assess the efficacy of autologous bone marrow-derived mononuclear cell therapy in improving neurological function.
时间窗: 0, 3, 6, 9, 12 and 15 months
次要结局
- To determine the impact of therapy on quality of life in patients with neurological disorders.
研究者
Anchal Aggarwal
L.L.R. Hospital and G.S.V.M. Medical College