Skip to main content
OpenTrials
Completed

NCT Number: NCT03225651

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stem Cell Transplantation Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 10000, Vietnam

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Stem Cell Transplantation

Biological

Transplantation of Autologous Bone Marrow Mononuclear cells

Psychological therapy and Rehabilitation

Behavioral

Psychological Therapy and Rehabilitation for autism children around 3 months

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Other

Registry information

Official study title

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

Acronym: ASPRA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 21, 2017
Registry last updated
Sep 6, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.