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Completed

NCT Number: NCT02627131

Autologous Bone Marrow Stem Cell Therapy for Autism

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

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Key information

Conditions

Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vinmec International Hospital

Hanoi, Vietnam

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous bone marrow mononuclear cells

Biological

Transplantation of Autologous Bone Marrow Mononuclear Cells

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vinmec Healthcare System

Other

Registry information

Official study title

Autologous Bone Marrow Stem Cell Therapy for Autism: An Open Label Uncontrolled Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 10, 2015
Registry last updated
Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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