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

Vinmec Research Institute of Stem Cell and Gene Technology30 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stem Cell Transplantation

Interventions

Stem cell transplantationBIOLOGICAL

Transplantation of Autologous Bone Marrow Mononuclear cells

Psychological therapy and RehabilitationBEHAVIORAL

Psychological Therapy and Rehabilitation for autism children around 3 months

Eligibility

Sex: ALLMin age: 3 YearsMax age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Vietnam

Outcomes

Primary Outcomes

Assess the change in autism level by using tools

using total score of childhood autism rating scale, autism diagnostic observation schedule second edition, DENVER II, Indian Scale for assessment of Autism

Time frame: 6 months and 12 months after transplantation

Evaluate the safety of therapy by record number of adverse events

Time frame: Through study completion, an average of 12 months

Data from ClinicalTrials.gov

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