Autologous BMMNCs Combined With Educational Intervention for ASD

NCT05307536 PHASE2 COMPLETED

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 disorder (ASD). Inclusion criteria: Male/Female patients diagnosed with Autism disorder based on DSM-V scale, the patient is between 3 to 7 years old, a patient has a medium level to server level of autism (CARS score\>=30 to \<50), VARS-2 \>=50, patient's parent or caregiver must have the educational level of high school or above, patient's family has given consent to participate in the study. Exclusion criteria for treatment group: patient above seven years of age and smaller than 3-year old, autistic patients having epilepsy, hydrocephalus with ventricular drain, allergy to anesthetic agents, severe health conditions such as cancer, failure of heart, lung, liver, or kidney, active infections, children with birth defects of the spine.

Details

Lead sponsor	Vinmec Research Institute of Stem Cell and Gene Technology
Phase	PHASE2
Status	COMPLETED
Enrolment	54
Start date	Sun Dec 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Sat Dec 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Autism Spectrum Disorder

Interventions

• Autologous BMMNCs transplantation and educational intervention
• Educational intervention

Countries

Vietnam