NCT01502488撤回1 期
An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously in Patients With Autism
Ageless Regenerative Institute2 个研究点 分布在 1 个国家开始时间: 2016年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Improvement in the Childhood Autism Rating Scale，CARS
研究概览
简要总结
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- Is treatment effective in improving the disease pathology of patients with Autism.
详细描述
This will be an open-label, non-randomized multi-center patient sponsored study of ASC implantation after liposuction using an IV delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered intravenously.
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
- 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
- •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.
- •Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have expert consultation to determine eligibility based on the patient's infectious status
- •Enrollment in other trials in the last 3 months without agreement to discontinue them.
- •Life expectancy < 6 months due to concomitant illnesses.
- •Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- •Patients on chronic immunosuppressive transplant therapy
- •Active clinical infection within one week of enrollment.
- •Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- •History of cancer
- •Parental unwillingness and/or not able to give written informed consent.
结局指标
主要结局
Improvement in the Childhood Autism Rating Scale，CARS
时间窗: 6 months
Improvement in the Clinical Global Impression Scale, CGI
时间窗: 6 months
次要结局
- Improvement in the Aberrant Behavior Checklist, ABC(6 months)
研究者
研究点 (2)
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