Phase Ι/Π Study of Stem Cell Therapy in Patients With Autism
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Childhood Autism Rating Scale，CARS
研究概览
简要总结
Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive behavior, while the therapeutic effect of current treatments remains limited progress .Neural hypoperfusion and immune deregulation are the two key pathologies associated with Autism. Human umbilical cord mesenchymal stem cells (hUC-MSCs) and human cord blood mononuclear cells (hCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. In this study, the safety and efficacy of hUC-MSCs and hCB-MNCs transplantation will be evaluated in patients with Autism.
详细描述
To investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of Autism.
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 3 and 12 years.
- •DSM-IV diagnosis of Autistic Disorder.
- •Total score of CARS ≥
- •Parents or legal guardian willing to sign the ICF.
排除标准
- •Any history of hypersensitivity to serum products, or other known drug and food allergy.
- •History of prior or current DSM-IV psychotic disorder (e.g., schizophrenia, bipolar disorder, other psychosis), Pervasive Developmental Disorder not otherwise specified (PDD NOS), Asperger's, or Rett's.
- •History of Epileptic seizure activity in the past 6 months.
- •Autism caused by seizure disorders (active), cerebrovascular disease or brain trauma.
- •The global autism ratings are assessed as being absent, minimal or mild.
- •Existing moderate or severe extrapyramidal symptoms (EPS) or history of tardive dyskinesia.
- •Subjects who have displayed significant self-injurious behavior (children who have caused visible harm to themselves).
- •Acute and chronic hepatitis.
- •Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
- •Severe pulmonary and hematological disease, malignancy or hypo-immunity.
- •Currently undertaking other treatment that may affect the safety/efficacy of stem cells.
- •Enrollment in other trials in the last 3 months.
- •Other criteria the investigator consider improper for inclusion.
结局指标
主要结局
Childhood Autism Rating Scale，CARS
时间窗: 6 months after treatment
Clinical Global Impression Scale，CGI
时间窗: 6 months after treatment
次要结局
- Aberrant Behavior Checklist，ABC(6 months after treatment)
- Adverse Event and Serious Adverse Event(6 months after treatment)