drugset / Trial / NCT02176317

Autologous Umbilical Cord Blood Infusion for Children With Autism Spectrum Disorder (ASD)

NCT02176317

NaSingle-groupOpen-labelTreatment

Summary

This study is a prospective phase 1 single-center trial designed to determine the safety of a single intravenous infusion of autologous umbilical cord blood in children with Autism Spectrum Disorder (ASD) and assess the feasibility of various outcome measures to determine which measure(s) can be used as primary and secondary endpoints for a future randomized phase 2 clinical trial. All subjects will receive infusion of cord blood cells at baseline with follow up assessments at 6 and 12 months.

Timeline

Start
2014-06
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous cord blood Cell therapy 1e+07 cells/kg Intravenous
Subject Autologous cord blood Cell therapy 5e+07 cells/kg Intravenous