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Autologous Bone Marrow Stem Cell Therapy for Autism

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: NCT02627131
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Vinmec Healthcare System

Brief Summary:
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism.

Condition or disease Intervention/treatment Phase
Autistic Disorder Biological: Autologous Bone Marrow Mononuclear Cells Phase 2

Detailed Description:
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism of 24 patients at Vinmec International Hospital, Hanoi, Vietnam

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Stem Cell Therapy for Autism: An Open Label Uncontrolled Clinical Trial
Study Start Date : April 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Stem cell transplantation
2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward
Biological: Autologous Bone Marrow Mononuclear Cells
Transplantation of Autologous Bone Marrow Mononuclear Cells




Primary Outcome Measures :
  1. Change in Total Score of Childhood Autism Rating Scale (CARS) [ Time Frame: 3 months and 6 months after transplantation ]
    CARS

  2. Number of adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Examples of adverse events to look for: vomiting, increased hyperactivity, fever, bleeding, hematoma, seizures and neurological deficits



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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-IV (DSM-IV) 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

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): NCT02627131


Locations
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Vietnam
Vinmec International Hospital
Hanoi, Vietnam
Sponsors and Collaborators
Vinmec Healthcare System
Investigators
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Study Chair: Liem T Nguyen, MD., PhD. Vinmec Healthcare System

Publications:
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Responsible Party: Vinmec Healthcare System
ClinicalTrials.gov Identifier: NCT02627131     History of Changes
Other Study ID Numbers: TBG 003
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data without personal identifiers will be published on Dryad.

Keywords provided by Vinmec Healthcare System:
Autism
Stem Cells

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders