FLT(3'-Deoxy-3'-[F-18]Fluorothymidine)-PET Activity Change After Allogeneic Umbilical Cord Blood Cell Therapy in Cerebral Palsy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Comparison of FLT-PET Activity Change
研究概览
简要总结
This is randomized placebo-controlled trial to recognize new cell regeneration in the brain using FLT-PET.
详细描述
FLT(3'-Deoxy-3'-[F-18]Fluorothymidine) has been developed as a cell-proliferation tracer. In animal study, FLT-PET was used as a tool that enables imaging and measuring of proliferation in the brain, thus it detects activity of endogenous neural stem cells noninvasively. This study aims to assess cell proliferation activity changes in the brain after Umbilical Cord Blood (UCB)Therapy for Cerebral Palsy patients using FLT-PET.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral Palsy
- •Abnormal muscle tone
- •Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
- •Willing to comply with all study procedure
排除标准
- •Medical instability including pneumonia or renal function at enrollment
- •Presence of known genetic disease
- •Presence of drug hypersensitivity which is related to this study remedy
- •Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
- •Decision by the principal investigator when there are unexpected events including brain surgery, that may affect the outcome
结局指标
主要结局
Comparison of FLT-PET Activity Change
时间窗: Baseline - 2 weeks
Comparison of FLT-PET Activity Change between UCB group and Placebo group during 2 weeks: To compare differences in regional brain FLT-PET activity between groups and differences between pre- and post-therapy imaging data. The baseline and post-therapy data of each group will be compared using paired t-test statistics.
次要结局
- Changes in Standardized Gross Motor Function(Baseline - 2 weeks - 3 months)
- Changes in Quality of Movement(Baseline - 2 weeks - 3 months)
- Changes in Neurodevelopmental Outcome(Baseline - 2 weeks - 3 months)
研究者
MinYoung Kim, M.D.
Associate Professor
Bundang CHA Hospital