Autologous BMMNCs Combined With Educational Intervention for ASD

PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

December 26, 2021

Primary Completion Date

June 30, 2023

Study Completion Date

July 30, 2023

Conditions
Autism Spectrum Disorder
Interventions
COMBINATION_PRODUCT

Autologous BMMNCs transplantation and educational intervention

"Biological/ Vaccine: Autologous bone marrow-derived mononuclear cell infusion (BM-MNCs) will be administrated at baseline, and the second infusion will be performed six months after the first administration. For each transplantation, the bone marrow will be harvested through an anterior iliac crest puncture under general anesthesia in the operating theatre. The volume collected depends on the patient's body weight based on our experience from a previous study as follows: 8 ml/kg for patients under 10 kg; \[80 ml + (body weight in kg - 10) x 7 ml\] for patients above 10 kg but no more than 250 ml in total.~Educational intervention: 6 months based on the Early Start Denver Model"

COMBINATION_PRODUCT

Educational intervention

Educational intervention: 6 months based on the Early Start Denver Model

Trial Locations (1)

10000

Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi

All Listed Sponsors
lead

Vinmec Research Institute of Stem Cell and Gene Technology

OTHER

NCT05307536 - Autologous BMMNCs Combined With Educational Intervention for ASD | Biotech Hunter | Biotech Hunter