Autologous BMMNCs Combined With Educational Intervention Versus Educational Intervention for ASD

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    54
  • sponsor
    Vinmec Research Institute of Stem Cell and Gene Technology
Updated on 19 April 2022
Accepts healthy volunteers

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 disorder (ASD). Inclusion criteria includes: Male/Female patients diagnosed with Autism disorder based on DSM-V scale, patient is between from 3 to 7 years old, 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 educational level of high school or above, patient's family has given consent to participate in the study. Exclusion criteria for treatment group includes: patient above 7 years of age and smaller than 3 year old, austistic 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.

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 marrow mononuclear cell transplantation combined intervention education (n =27). The bone marrow mononuclear cell will be applied for 27 patients in the treatment group infuse via the intrathecal administration. The primary outcome is measured by the number of AEs/SAEs during BMMNCs infusion. The secondary outcome was measured by clinical examinations were performed at baseline and then at 02, 06, and 12 months after the first infusion. Multiple tools were used to diagnose and determine the severity of ASD level, including DSM-5, CARS, the Vineland Adaptive Behavior Scales Second Edition (VABS-II), and the Clinical Global Impression (CGI). DSM-5, which was published in May 2013, provides new diagnostic criteria for ASD

Details
Condition Autism Spectrum Disorder
Treatment Autologous BMMNCs transplantation and educational intervention
Clinical Study IdentifierNCT05307536
SponsorVinmec Research Institute of Stem Cell and Gene Technology
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 serve level of autism (CARS score >=34 to 50)
Patient's parent or caregiver must have educational level of high school or above
Patient's family has given consent to participate in the study

Exclusion Criteria

Patient is above 7 years of age
Autistic patient having epilepsy
Patient with coagulation disorders
Hydrocephalus with ventricular drain
Allergy to anesthetic agnets
Sever health conditions such as cancer, failure of heart, lung, liver, or kidney
Active infections
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