Autologous Bone Marrow Stem Cell Therapy for Autism

Vinmec Healthcare System

Status and phase: Completed; Phase 2

Conditions: Autistic Disorder

Treatments: Biological: Autologous Bone Marrow Mononuclear Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02627131

TBG 003

Details and patient eligibility

About

The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism.

Full 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

Enrollment: 24 patients

Sex: All

Ages: 3 to 16 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Stem cell transplantation

Experimental group

Description:

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

Treatment:

Biological: Autologous Bone Marrow Mononuclear Cells