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Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism
资助者: Vinmec Research Institute of Stem Cell and Gene Technology
合作者:
监督者:

预计研究完成时间: 2018-12-18
预计完成时间: 2018-12-18

详细标题

  • Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism: An Open Label Controlled Clinical Trial

简略摘要

  • The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation for Autism children

详细摘要

  • The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation in the management of autism of 60 patients at Vinmec Research Institute of Stem Cell and Gene Technology Hanoi, Vietnam from January 2017 to December 2018

研究层级

  • Interventional

研究阶段

  • Phase 2

研究设计

  • Allocation: Non-Randomized
    Intervention Model: Parallel Assignment
    Masking: None (Open Label)
    Masking Description:
    Open Label
    Primary Purpose: Treatment

研究条件

  • Stem Cell Transplantation

研究干预

  • Biological: Stem cell transplantation Transplantation of Autologous Bone Marrow Mononuclear cells Behavioral: Psychological therapy and Rehabilitation Psychological Therapy and Rehabilitation for autism children around 3 months

研究手段

  • Experimental: Stem cell transplantation Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward Interventions: Biological: Stem cell transplantation Behavioral: Psychological therapy and Rehabilitation Experimental: Psychological therapy and rehabilitation Psychological therapy Rehabilitation in 3 months Interventions: Biological: Stem cell transplantation Behavioral: Psychological therapy and Rehabilitation

出版物


研究状态

  • Recruiting

招聘人数

  • 60

招聘准则

  • Inclusion Criteria: Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-V diagnostic criteria for autistic disorder Exclusion Criteria: Epilepsy Hydrocephalus with ventricular drain Coagulation disorders Allergy to anesthetic agents Severe health conditions such as cancer, failure of heart, lung, liver or kidney Active infections Severe psychiatric disorders Rett syndrome Fragile X syndrome

性别

  • Sexes Eligible for Study: All

年龄

  • 3 Years to 7 Years   (Child)

志愿者

  • Yes

联系人


国别

  • Vietnam

NCT编号

  • NCT03225651