Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism
Phase 2
Completed
- Conditions
- Stem Cell Transplantation
- Registration Number
- NCT03225651
- Brief Summary
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation for Autism children
- Detailed Description
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation in the management of autism of 60 patients at Vinmec Research Institute of Stem Cell and Gene Technology Hanoi, Vietnam from January 2017 to December 2018
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-V 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
- Rett syndrome
- Fragile X syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assess the change in autism level by using tools 6 months and 12 months after transplantation using total score of childhood autism rating scale, autism diagnostic observation schedule second edition, DENVER II, Indian Scale for assessment of Autism
Evaluate the safety of therapy by record number of adverse events Through study completion, an average of 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vinmec Research Institute of Stem Cell and Gene Technology
🇻🇳Hanoi, Vietnam
Vinmec Research Institute of Stem Cell and Gene Technology🇻🇳Hanoi, Vietnam