Status:
COMPLETED
Autologous BMMNCs Combined With Educational Intervention for ASD
Lead Sponsor:
Vinmec Research Institute of Stem Cell and Gene Technology
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-7 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow mononuclear cell infusion combined with educational intervention for children with autism spectrum disor...
Detailed Description
A total of 54 patients with autism spectrum disorder (aged 3-7) will be recruited and divided into two groups: the control group (only intervention education) (n = 27) and the treatment group (bone ma...
Eligibility Criteria
Inclusion
- Patient is between 3 to 7 years old
- Male/Female patient diagnosed with Autism disorder according to the diagnostic criteria for Autism Spectrum Disorder in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Patient has a medium level to the most severe level of autism (CARS score \>=34 to 50)
- Patient's parent or caregiver must have an educational level of high school or above
- Patient's family has given consent to participate in the study
Exclusion
- Patient is above seven years of age
- Autistic patient having epilepsy
- Patient with coagulation disorders
- Hydrocephalus with ventricular drain
- Allergy to anesthetic agents
- Sever health conditions such as cancer, failure of heart, lung, liver, or kidney
- Active infections
Key Trial Info
Start Date :
December 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05307536
Start Date
December 26 2021
End Date
July 30 2023
Last Update
June 4 2024
Active Locations (1)
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1
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam, 10000