NCT04873752已完成1 期
An Exploratory Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety: Adverse Event
研究概览
简要总结
UDI-001 is administered to pediatric patients with cerebral palsy attributed to periventricular leukomalacia (PVL) multiple times to investigate its safety and efficacy.
详细描述
This is the first study of UDI-001 to be administered to children. Pediatric patients with cerebral palsy attributed to PVL are enrolled to the study and umbilical cord derived mesenchymal stromal cells (UC-MSCs) are administered to those patients multiple times intravenously. Safety and efficacy of UC-MSCs are evaluated for 52 weeks after the first administration.
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
- 12 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 12 months and < 24 months corrected age at the time of informed consent
- •Diagnosed with cerebral palsy
- •Diagnosed with PVL
- •GMFCS level between II and IV
- •Able to obtain written informed consent from parents (legal representative)
排除标准
- •Presence of progressive neurological disease
- •Presence of congenital anomaly
- •Diagnosed with Grade 3 or more severe intraventricular hemorrhage
- •Body weight < 5kg
- •Profound intellectual disorder
- •Complication of serious infection such as sepsis
- •Requirement of mechanical ventilation
- •Complication of serious organ failure such as kidney, liver or heart diseases or others and considered to be inappropriate
- •Diagnosed with or suspected of hypsarrhythmia
- •Positive for HBV, HCV, HIV or HTLV-1
- •Patients who have received cell therapy
- •Patients who have undergone selective dorsal rhizotomy or received botulinum toxin products within a certain period of time
研究组 & 干预措施
UDI-001
Experimental
Four cycles with 8 administrations
干预措施: UDI-001 (Biological)
结局指标
主要结局
Safety: Adverse Event
时间窗: until Week 52
Adverse events which appear in the participants after the treatment
次要结局
- Gross Motor Function Measure Score (GMFM Score)(baseline to Week 52)
- Gross Motor Function Classification System (GMFCS)(baseline to Week 52)
- Function Independence Measure for Children (WeeFIM)(baseline to Week 52)
- Kyoto Scale of Psychological Development Test 2001 (KSPD)(baseline to Week 52)
研究者
研究点 (1)
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