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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Stem Cell Transplantation

Intervention / Treatment
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* Biological: Stem cell transplantation
* Behavioral: Psychological therapy and Rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem cell transplantation<br>Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward | Biological: Stem cell transplantation<br>* Transplantation of Autologous Bone Marrow Mononuclear cells<br>Behavioral: Psychological therapy and Rehabilitation<br>* Psychological Therapy and Rehabilitation for autism children around 3 months<br>|
| Experimental: Psychological therapy and rehabilitation<br>Psychological therapy Rehabilitation in 3 months | Biological: Stem cell transplantation<br>* Transplantation of Autologous Bone Marrow Mononuclear cells<br>Behavioral: Psychological therapy and Rehabilitation<br>* Psychological Therapy and Rehabilitation for autism children around 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months and 12 months after transplantation | 
| Evaluate the safety of therapy by record number of adverse events |  | Through study completion, an average of 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem cell, Autism, Psychological, Rehabilitation