Autologous BMMNCs Combined With Educational Intervention for ASD

Last updated: June 3, 2024
Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Overall Status: Completed

Phase

2

Condition

Asperger's Disorder

Williams Syndrome

Treatment

Autologous BMMNCs transplantation and educational intervention

Educational intervention

Clinical Study ID

NCT05307536
ISC.19.50
  • Ages 3-7
  • All Genders
  • Accepts Healthy Volunteers

Study 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: 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is between 3 to 7 years old

  • Male/Female patient diagnosed with Autism disorder according to the diagnosticcriteria for Autism Spectrum Disorder in Diagnostic and Statistical Manual of MentalDisorders, Fifth Edition (DSM-5)

  • Patient has a medium level to the most severe level of autism (CARS score >=34 to

  • 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

Exclusion Criteria:

  • 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

Study Design

Total Participants: 54
Treatment Group(s): 2
Primary Treatment: Autologous BMMNCs transplantation and educational intervention
Phase: 2
Study Start date:
December 26, 2021
Estimated Completion Date:
July 30, 2023

Study 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 to 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 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, 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

Connect with a study center

  • Vinmec Research Institute of Stem Cell and Gene Technology

    Hanoi, 10000
    Vietnam

    Site Not Available

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