Autologous Bone Marrow Stem Cell Therapy for Autism
Phase 2
Completed
- Conditions
- Autistic Disorder
- Interventions
- Biological: Autologous Bone Marrow Mononuclear Cells
- Registration Number
- NCT02627131
- Lead Sponsor
- Vinmec Healthcare System
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stem cell transplantation Autologous Bone Marrow Mononuclear Cells 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vinmec International Hospital
🇻🇳Hanoi, Vietnam