NCT07106021进行中（未招募）1 期
A Phase 1b/2a Study Assessing the Safety and Efficacy of Intraputamenal Dopaminergic Stem Cell Transplants in Patients With Idiopathic Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 5
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This clinical trial is designed to test the safety and tolerability of the study intervention, RNDP-001, which will be implanted into the brain of study participants during a surgical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease consistent with the Movement Disorders Society Clinical Criteria
- •Age 45 to 75
- •Medically stable to undergo a surgical procedure
排除标准
- •Known Parkinson's disease gene mutation or variant
- •Previous infusion therapy or surgery for Parkinson's disease
- •History of allergic reaction or intolerance to an immunotherapeutic agent
- •Contraindication to MRI
- •Clinically significant medical conditions likely to interfere with the surgical procedure or study assessments
研究组 & 干预措施
First patient group
Experimental
Low dose
干预措施: Syringe Front-Loading Device (Device)
Second patient group
Experimental
High dose
干预措施: Syringe Front-Loading Device (Device)
Third patient group
Experimental
Best dose
干预措施: Syringe Front-Loading Device (Device)
First patient group
Experimental
Low dose
干预措施: RNDP-001 (Biological)
Second patient group
Experimental
High dose
干预措施: RNDP-001 (Biological)
Third patient group
Experimental
Best dose
干预措施: RNDP-001 (Biological)
结局指标
主要结局
Safety and Tolerability
时间窗: Baseline to 15 months post-transplant
The incidence of adverse events (AEs), serious AEs, AEs of special interest, and patient withdrawals
次要结局
- Changes from Baseline in Quality ON time measured by PD diary(Baseline to 15 months post-transplant)
- Changes in Dopaminergic Function and Activity in the Brain(Baseline to 15 months post-transplant)
研究者
研究点 (5)
Loading locations...
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