To Study the Safety and Efficacy of Bone Marrow Derived Mesenchymal Stem Cells Transplant in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Improvement in clinical condition of the patient assessed using UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE) and Time Tests.
研究概览
简要总结
This study is intended to look at the safety and efficacy of the use of autologous bone marrow derived stem cell transplant in patients with advanced Parkinson's disease.
详细描述
Parkinson's disease, a neurodegenerative disorder, still at its best can only be controlled by medical or surgical treatment. For more than two decades various groups have tried using modified cell transplants for curing this disease. Earlier results with use of fetal mesencephalic cell transplant were encouraging, but this had to be discontinued due to severe side effects.
Current interest, in the use of Mesenchymal stem cells as a pluripotent cell for developing neural cells has been the background for this study. Reliance Life sciences had found encouraging results with the use of human MSCs in Rat model of PD. Based on this and other data, Jaslok Hospital and Research Centre has initiated a pilot study to investigate the efficacy of Autologous MSCs in treating advanced PD. This cells will be harvested from bone marrow, processed at RLS laboratory and transplanted by stereotactic techniques into the striatum of the patient.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •History of intracranial surgeries or implantation of a device for Parkinson's disease two years prior to treatment.
- •History of psychiatric disorders like schizophrenia or psychotic disorders.
- •History of other malignancy, with the exception of treated cutaneous squamous cell or basal cell carcinoma, within 5 years.
- •Contraindication for MRI
- •General medical contraindications for surgery like coagulopathy
- •Subjects with abnormal hematology and chemistry values, unless the out of range values are clinically significant with respect to general surgery.
- •Severe skin infection or osteomyelitis at the site of bone marrow aspiration potentially limiting the procedure.
- •Positive test results for HIV.
- •History of drug or alcohol abuse
- •Pregnant or nursing women
研究组 & 干预措施
Therapy for Parkinson's disease
Stem cell derived from the bone marrow of the patient will be stereotactically transplanted in the striatum.These stem cell are the expected to grow up into dopamine secreting neural cells.
干预措施: Autologous Bone marrow derived stem cells transplant (Procedure)
结局指标
主要结局
Improvement in clinical condition of the patient assessed using UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE) and Time Tests.
时间窗: Up to 18 months from the day of stem cell transplant.
次要结局
未报告次要终点
研究者
Dr Paresh Doshi
In-charge Stereotactic and Functional neurosurgery
Jaslok Hospital and Research Centre