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

Primary Purpose

Stem Cell Transplantation

Status
Completed
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
Stem cell transplantation
Psychological therapy and Rehabilitation
Sponsored by
Vinmec Research Institute of Stem Cell and Gene Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stem Cell Transplantation focused on measuring Stem cell, Autism, Psychological, Rehabilitation

Eligibility Criteria

3 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vinmec Research Institute of Stem Cell and Gene Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stem cell transplantation

Psychological therapy and rehabilitation

Arm Description

Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward

Psychological therapy Rehabilitation in 3 months

Outcomes

Primary Outcome Measures

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
Evaluate the safety of therapy by record number of adverse events

Secondary Outcome Measures

Full Information

First Posted
July 5, 2017
Last Updated
September 5, 2019
Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03225651
Brief Title
Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism
Acronym
ASPRA
Official Title
Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism: An Open Label Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cell Transplantation
Keywords
Stem cell, Autism, Psychological, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem cell transplantation
Arm Type
Experimental
Arm Description
Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward
Arm Title
Psychological therapy and rehabilitation
Arm Type
Experimental
Arm Description
Psychological therapy Rehabilitation in 3 months
Intervention Type
Biological
Intervention Name(s)
Stem cell transplantation
Intervention Description
Transplantation of Autologous Bone Marrow Mononuclear cells
Intervention Type
Behavioral
Intervention Name(s)
Psychological therapy and Rehabilitation
Intervention Description
Psychological Therapy and Rehabilitation for autism children around 3 months
Primary Outcome Measure Information:
Title
Assess the change in autism level by using tools
Description
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
Title
Evaluate the safety of therapy by record number of adverse events
Time Frame
Through study completion, an average of 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Vinmec Research Institute of Stem Cell and Gene Technology
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
32902182
Citation
Nguyen Thanh L, Nguyen HP, Ngo MD, Bui VA, Dam PTM, Bui HTP, Ngo DV, Tran KT, Dang TTT, Duong BD, Nguyen PAT, Forsyth N, Heke M. Outcomes of bone marrow mononuclear cell transplantation combined with interventional education for autism spectrum disorder. Stem Cells Transl Med. 2021 Jan;10(1):14-26. doi: 10.1002/sctm.20-0102. Epub 2020 Sep 9. Erratum In: Stem Cells Transl Med. 2021 Dec;10(12):1721.
Results Reference
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Learn more about this trial

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

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