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

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ClinicalTrials.gov Identifier: NCT03225651
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Vinmec Research Institute of Stem Cell and Gene Technology

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

Condition or disease Intervention/treatment Phase
Stem Cell Transplantation Biological: Stem cell transplantation Behavioral: Psychological therapy and Rehabilitation Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism: An Open Label Controlled Clinical Trial
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Stem cell transplantation
Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward
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

Experimental: Psychological therapy and rehabilitation
Psychological therapy Rehabilitation in 3 months
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




Primary Outcome Measures :
  1. 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

  2. Evaluate the safety of therapy by record number of adverse events [ Time Frame: Through study completion, an average of 12 months ]


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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225651


Locations
Vietnam
Vinmec Research Institute of Stem Cell and Gene Technology Recruiting
Hanoi, Vietnam, 10000
Contact: Liem T Nguyen, MD, PhD    (+8424)39743556 ext 1420    v.liemnt@vinmec.com   
Sponsors and Collaborators
Vinmec Research Institute of Stem Cell and Gene Technology

Responsible Party: Vinmec Research Institute of Stem Cell and Gene Technology
ClinicalTrials.gov Identifier: NCT03225651     History of Changes
Other Study ID Numbers: VinmecRISCGT69
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vinmec Research Institute of Stem Cell and Gene Technology:
Stem cell
Autism
Psychological
Rehabilitation