Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism: An Open Label Controlled Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stem Cell Transplantation
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Assess the change in autism level by using tools
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-V diagnostic criteria for autistic disorder
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Assess the change in autism level by using tools
Time Frame: 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
Time Frame: Through study completion, an average of 12 months