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Autologous Bone Marrow Stem Cell Therapy for Autism

Primary Purpose

Autistic Disorder

Status
Completed
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
Autologous Bone Marrow Mononuclear Cells
Sponsored by
Vinmec Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring Autism, Stem Cells

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-IV (DSM-IV) 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

Sites / Locations

  • Vinmec International Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem cell transplantation

Arm Description

2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward

Outcomes

Primary Outcome Measures

Change in Total Score of Childhood Autism Rating Scale (CARS)
CARS
Number of adverse events
Examples of adverse events to look for: vomiting, increased hyperactivity, fever, bleeding, hematoma, seizures and neurological deficits

Secondary Outcome Measures

Full Information

First Posted
December 7, 2015
Last Updated
December 8, 2015
Sponsor
Vinmec Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT02627131
Brief Title
Autologous Bone Marrow Stem Cell Therapy for Autism
Official Title
Autologous Bone Marrow Stem Cell Therapy for Autism: An Open Label Uncontrolled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vinmec Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism.
Detailed Description
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism of 24 patients at Vinmec International Hospital, Hanoi, Vietnam

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
Autism, Stem Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem cell transplantation
Arm Type
Experimental
Arm Description
2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward
Intervention Type
Biological
Intervention Name(s)
Autologous Bone Marrow Mononuclear Cells
Intervention Description
Transplantation of Autologous Bone Marrow Mononuclear Cells
Primary Outcome Measure Information:
Title
Change in Total Score of Childhood Autism Rating Scale (CARS)
Description
CARS
Time Frame
3 months and 6 months after transplantation
Title
Number of adverse events
Description
Examples of adverse events to look for: vomiting, increased hyperactivity, fever, bleeding, hematoma, seizures and neurological deficits
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-IV (DSM-IV) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liem T Nguyen, MD., PhD.
Organizational Affiliation
Vinmec Healthcare System
Official's Role
Study Chair
Facility Information:
Facility Name
Vinmec International Hospital
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data without personal identifiers will be published on Dryad.
Citations:
PubMed Identifier
24062774
Citation
Sharma A, Gokulchandran N, Sane H, Nagrajan A, Paranjape A, Kulkarni P, Shetty A, Mishra P, Kali M, Biju H, Badhe P. Autologous bone marrow mononuclear cell therapy for autism: an open label proof of concept study. Stem Cells Int. 2013;2013:623875. doi: 10.1155/2013/623875. Epub 2013 Aug 25.
Results Reference
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Autologous Bone Marrow Stem Cell Therapy for Autism

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