NCT05307536CompletedPhase 2
Autologous BMMNCs Combined With Educational Intervention for ASD
Autologous Bone Marrow Mononuclear Cell Transplantation Combined With Educational Intervention for Autism Spectrum Disorders (ASD): A Phase 2 Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 12 Feb 2022
- Start date
- 26 Dec 2021
- Primary completion date
- 30 Jun 2023
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Diseases
- Autism
- NCT number
- NCT05307536
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 54
- From 26 Dec 2021 to the primary completion date, 30 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Autistic patient having epilepsy
- Patient with coagulation disorders
- Allergy to anesthetic agents
- Sever health conditions such as cancer, failure of heart, lung, liver, or kidney
- Active infections
Age
- Patient is above seven years of age
Other
- Hydrocephalus with ventricular drain
Who the study is looking for
- 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
Age in the registry: 3 years to 7 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vinmec Research Institute of Stem Cell and Gene Technology Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.