Comparison of Umbilical Cord Blood vs Personalized Treatment for Improving Autistic Spectrum Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Improvement in behaviour, interaction with family and peers
研究概览
简要总结
The clinical study evaluates in an open-label, crossover design the comparative efficacy and safety of intranasal oxytocin and autologous umbilical cord blood for improving the functioning of children with autistic spectrum disorder
详细描述
Children aged 3-7 years diagnosed with autistic spectrum disorder and who did not previously receive oxytocin or umbilical cord blood treatments, will be enrolled to receive both treatments in random order. Assessment of functioning impairment will be done with QCHAT/M-CHAT/CAST questionnaires initially, at 2 months, 6 months and 1 year after first treatments. Either oxytocin or cord blood will be administered initially and at visit 2, which will take place at 2 months. All children will receive both treatments. A total of 25-40 children are expected to enroll and complete the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of autistic spectrum disorder
排除标准
- •metabolic or genetic disorder (ex storage disease, Down, etc),
研究组 & 干预措施
Oxytocin
Intranasal Oxytocin
干预措施: Intranasal oxytocin (Drug)
Autologous umbilical cord blood
Intravenous administration of autologous umbilical cord blood
干预措施: Autologous umbilical cord blood (Biological)
结局指标
主要结局
Improvement in behaviour, interaction with family and peers
时间窗: At 2 months after administration of either treatment
change in scores on M-CHAT (Modified Checklist for Autism in Toddlers) questionnaire; total score, maximum 20, lower is better
Improvement in behavior and social interaction
时间窗: At 2 months after administration of either treatment
change in score on Q-CHAT (Quantitative Checklist for Autism in Toddlers) questionnaire; total score, maximum 100, lower is better
Improvement in overall functioning of the child
时间窗: At 2 months after administration of either treatment
change in score on CAST (The Childhood Autistic Spectrum Test) questionnaire; Total score, maximum 39, lower is better
次要结局
未报告次要终点