Autologous Bone Marrow Stem Cell Therapy for Autism

NCT ID: NCT02627131

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autistic Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Autism Stem Cells

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stem cell transplantation

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

Group Type EXPERIMENTAL

Autologous Bone Marrow Mononuclear Cells

Intervention Type BIOLOGICAL

Transplantation of Autologous Bone Marrow Mononuclear Cells

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Autologous Bone Marrow Mononuclear Cells

Transplantation of Autologous Bone Marrow Mononuclear Cells

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vinmec Healthcare System

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Liem T Nguyen, MD., PhD.

Role: STUDY_CHAIR

Vinmec Healthcare System

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vinmec International Hospital

Hanoi, , Vietnam

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Vietnam

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24062774 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TBG 003

Identifier Type: -

Identifier Source: org_study_id