NCT06377982尚未招募1 期
A Phase I, Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Safety and Efficacy of Allogeneic Human Umbilical Cord Blood Infusion in Children with Cerebral Palsy
StemCyte Taiwan Co., Ltd.0 个研究点目标入组 12 人开始时间: 2025年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 主要终点
- safety-TEAE
研究概览
简要总结
A phase I, randomized, double-blind, placebo-controlled clinical study to assess the safety and efficacy of allogeneic human umbilical cord blood infusion in children with cerebral palsy
详细描述
This is a phase I study to evaluate the safety and efficacy in hUCB treatment on the patients with cerebral palsy (CP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female underage at the time of screening.
- •With a confirmed diagnosis of CP
- •non-progressive motor disability
- •brain dysfunction
排除标准
- •Judged by the Investigator to be not suitable/eligible for study participation.
研究组 & 干预措施
hUCB treatment
Experimental
Human cord blood infusion
干预措施: hUCB (Biological)
结局指标
主要结局
safety-TEAE
时间窗: From screening to 56 weeks
Frequency and incidence of treatment-emergent adverse events (TEAEs).
次要结局
未报告次要终点
研究者
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