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

Phase 2

Completed

• Conditions: Stem Cell Transplantation
• Interventions: Biological: Stem cell transplantation; Behavioral: Psychological therapy and Rehabilitation

• Registration Number: NCT03225651
• Lead Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-07-05
• Study Start: 2017-07-18
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Status Verified: 2018-11
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychological therapy and rehabilitation	Psychological therapy and Rehabilitation	Psychological therapy Rehabilitation in 3 months
Psychological therapy and rehabilitation	Stem cell transplantation	Psychological therapy Rehabilitation in 3 months
Stem cell transplantation	Stem cell transplantation	Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward
Stem cell transplantation	Psychological therapy and Rehabilitation	Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward

Primary Outcome Measures

Name	Time	Method
Assess the change in autism level by using tools	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
Evaluate the safety of therapy by record number of adverse events	Through study completion, an average of 12 months

Trial Locations

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology; 🇻🇳 Hanoi, Vietnam