Prospective open-labeled clinical study to evaluate the safety and efficacy of R-HSC-001 in patients with Parkinsons Disease.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in UPDRS score
研究概览
简要总结
Mesenchymal stem cells (MSCs) have been proposed as good candidates for cell replacement therapy for neurodegenerative diseases .This study is a prospective, open label multicentric clinical trial.The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow derived MSCs i.e. R-HSC-001 in patients with Parkinson’s Disease. Total 10 patients will be enrolled across the centers in India. Approximately 5-30 million cells per patient will be administered in equal proportion bilaterally in the putamen by MRI guided stereotactic surgery. Efficacy outcome will be assessded by change in UPDRS score at 1, 3, 6 and 12 month after IP administration. The safety will be assessed by recording all treatment emergent adverse events during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 35.00 Day(s) 至 75.00 Day(s)（—）
- 性别
- All
入选标准
- •Male and female of between 35 to 75 years of age.
- •Patients with current diagnosis of PD.
- •Patient is able to comply with and understand the required visit schedule and required tests and procedures.
排除标准
- •History of intracranial surgery.
- •History of malignancy.
- •Contraindication of MRI.
- •Significant coagnitive impairement.
- •Any contraindication to surgery.
- •Abnormal hematology and biochemistry.
- •Positive test result of HBsAg, HCV and HIV.
- •Pregnant and lactating mother.
结局指标
主要结局
Change in UPDRS score
时间窗: Decrease in UPDRS score at 6 month post treatment
次要结局
- To assess the safety of R-HSC-001 in patients with Parkinsons Disease(•Treatment emergent adverse effects)