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Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism (ASPRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03225651
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Vinmec Research Institute of Stem Cell and Gene Technology

Tracking Information
First Submitted Date  ICMJE July 5, 2017
First Posted Date  ICMJE July 21, 2017
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE July 18, 2017
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
  • Assess the change in autism level by using tools [ Time Frame: 6 months and 12 months after transplantation ]
    using total score of childhood autism rating scale, autism diagnostic observation schedule second edition, DENVER II, Indian Scale for assessment of Autism
  • Evaluate the safety of therapy by record number of adverse events [ Time Frame: Through study completion, an average of 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03225651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism
Official Title  ICMJE Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism: An Open Label Controlled Clinical Trial
Brief Summary 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
Detailed Description 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
Condition  ICMJE Stem Cell Transplantation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2017)
60
Actual Study Completion Date  ICMJE August 30, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03225651
Other Study ID Numbers  ICMJE VinmecRISCGT69
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vinmec Research Institute of Stem Cell and Gene Technology
Study Sponsor  ICMJE Vinmec Research Institute of Stem Cell and Gene Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vinmec Research Institute of Stem Cell and Gene Technology
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP