NCT02192749已完成1 期
Open, Prospective Trial of Treatment of Autism Spectrum Disorders (ASD) Using Intravenous Infusion of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Allogeneic (not from the subject) human umbilical cord tissue-derived stem cells administered intravenously (IV) in a series of 4 infusions every 3 months over the course of one year is safe and will induce a therapeutic effect in autism patients.
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
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •Ages 6 to 16
- •Diagnostic and Statistical Manual of Mental Disorders (DSM IV) diagnosis of autism confirmed by Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview-Revised (ADI-R)
- •No anticipated changes in treatment for the study duration (e.g., diet, nutrients)
- •No additional biomedical treatments started 6 weeks prior to enrollment
- •No changes in dietary management for 3 months prior to enrollment
- •Ambulatory or require minimum support walking, per parent
- •Able to sit still for 5 minutes or longer with a preferred toy item, per parent
- •Adequate vision and hearing for the purposes of test administration, per parent
- •Adequate arm-hand-finger coordination (i.e., able to point) for learning and cognitive tasks used in outcome measurement, per parent
- •Stable and controlled mental disorder
- •Under the care of a caregiver willing to participate by attending regularly scheduled appointments and completing the necessary measures
- •Normal heavy metals test for lead and mercury levels performed within 30 days of first stem cell infusion
- •Must provide name and specialty of specialist who has made Autism Spectrum Disorder (ASD) diagnosis
- •Adequate financial means to cover $7,200 (US Dollars) plus travel expenses
排除标准
- •Significant prematurity at birth (less than 32 weeks gestation); or birth weight significantly below normal for gestational age (SGA - small for gestational age)
- •mental retardation
- •seizure disorder
- •auto-immune conditions
- •history of head trauma and other neurological or medical conditions
- •Abnormal heavy metals test for lead and mercury performed within 30 days of first stem cell infusion
- •Prior stem cell therapy of any kind
研究组 & 干预措施
Umbilical cord mesenchymal stem cells
Experimental
干预措施: Umbilical cord mesenchymal stem cells (Biological)
结局指标
主要结局
Number of participants with adverse events
时间窗: 89 weeks
次要结局
- Change from baseline thymus and activation-regulated chemokine (TARC)(13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks)
- Number of participants with a change in disability as measured by the Autism Treatment Evaluation Checklist (ATEC)(13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks)
- Change from baseline macrophage-derived chemokine (MDC)(13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks)
- Number of participants with a change in disability as measured by the Childhood Autism Rating Scale (CARS)(13 weeks, 25 weeks, 37 weeks, 49 weeks, 89 weeks)
研究者
研究点 (1)
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