Autistic Disorder
Conditions
Keywords
Autism, Stem Cells
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
Interventions
BIOLOGICALAutologous Bone Marrow Mononuclear Cells
Transplantation of Autologous Bone Marrow Mononuclear Cells
Sponsors
Vinmec Healthcare System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Score of Childhood Autism Rating Scale (CARS) | 3 months and 6 months after transplantation | CARS |
| Number of adverse events | Through study completion, an average of 6 months | Examples of adverse events to look for: vomiting, increased hyperactivity, fever, bleeding, hematoma, seizures and neurological deficits |
Countries
Vietnam
Outcome results
None listed