Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- ABC
研究概览
简要总结
To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of autism spectrum disorder.
详细描述
This is a Phase 1 clinical trial that constitutes two time points cohorts with participants who will receive intravenous autologous umbilical cord blood and 0.9% sodium chloride respectively. The timing of treatment is any time after the diagnosis of autism spectrum disorder. The investigator will proceed the groups during the same period.
- Demographic Data and Baseline Characteristics of the Studied Group were collected:
- Basic patient's information survey
- Medical history
- Physical examination
- Basic blood test result
- Autism Behavior Checklist,CARS before the treatment
- Brain Magnetic Resonance Imaging-Diffusion Tensor Imaging (MRIDTI) before the treatment
- Neurocognitive function test before the treatment
- Assessment of clinical condition in the course by measurement of blood pressure, heart and respiratory rates, temperature and adverse events was recorded.
- Autologous cord blood doses is 20-30ml (total Mononuclear cells# 1*10^7/kg)#the infusion speed is 1ml/min, and with same volume of 0.9% sodium chloride as placebo.
- The follow-up: clinical test until 24th month in 3 month gaps.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• A patient who was diagnosed with ASD.
排除标准
- •• In case a patient underwent a surgical procedure, or was administered autologous cord blood within one year before participating in a clinical trial.
- •Accompanied by a serious disease, such as chromosome abnormality, etc.
- •In case where a patient's medical condition is judged to be maladapted by a researcher.
- •In case a patient or his or her legal representative doesn't agree to participation in a clinical trial.
- •A patient having a predisposition to allergies.
- •A patient having serious disorders in the liver, kidney, and cardiopulmonary function.
研究组 & 干预措施
Placebo Comparator
Placebo 0.9% sodium chloride infusion any time after entering the Placebo Group, doses is 20-30ml. The infusion speed is 1ml/min.
干预措施: 0.9% Sodium Chloride (Drug)
Experimental
Autologous Umbilical Cord Blood Mononuclear Cells Therapy any time after the diagnosis of cerebral palsy, doses is 20-30ml (total Mononuclear cells#1*10^7/kg). The infusion speed is 1ml/min.
干预措施: Autologous Umbilical Cord Blood (Biological)
结局指标
主要结局
ABC
时间窗: up to 24 months after therapy at a 3-month interval
The Change of ABC score is used to assess the social and behavior function of the children who were diagnosised as ASD.
CARS
时间窗: up to 24 months after therapy at a 3-month interval
The Change of CARS score is used to assess the social and behavior function of the children who were diagnosised as ASD.
次要结局
未报告次要终点
研究者
Xiao Huimei
Dr
Guangdong Women and Children Hospital