NCT02627131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

December 7, 2015

Last Update Submit

December 8, 2015

Conditions

Autistic Disorder

Keywords

AutismStem Cells

Outcome Measures

Primary Outcomes (2)

  • Change in Total Score of Childhood Autism Rating Scale (CARS)

    CARS

    3 months and 6 months after transplantation

  • Number of adverse events

    Examples of adverse events to look for: vomiting, increased hyperactivity, fever, bleeding, hematoma, seizures and neurological deficits

    Through study completion, an average of 6 months

Study Arms (1)

Stem cell transplantation

EXPERIMENTAL

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

Biological: Autologous Bone Marrow Mononuclear Cells

Interventions

Autologous Bone Marrow Mononuclear CellsBIOLOGICAL

Transplantation of Autologous Bone Marrow Mononuclear Cells

Stem cell transplantation

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for autistic disorder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vinmec International Hospital

Hanoi, Vietnam

Location

Related Publications (1)

  • 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.

    PMID: 24062774BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Liem T Nguyen, MD., PhD.

    Vinmec Healthcare System

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 10, 2015

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 10, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will share

The data without personal identifiers will be published on Dryad.

Locations

VN(1)