Efficacy of Umbilical Cord Blood Infusion for Improving Outcomes of Children with Autism Spectrum Disorder: DukeACT

This program of research is sponsored by the Marcus Foundation.

Researchers at Duke University Medical Center are conducting a program of research to evaluate the efficacy of autologous and allogeneic cord blood for improving outcomes of children with autism spectrum disorder. This study is investigating whether a single intravenous infusion of umbilical cord blood can improve autism symptoms in children with autism spectrum disorder through a randomized, placebo controlled, Phase II clinical trial. Participants will be randomly assigned to one of two groups. One group will receive a single infusion of cord blood cells at the baseline visit, followed 6 months later by a single infusion of placebo. The second group will receive an infusion of placebo at the baseline visit, followed 6 months later by a single infusion of cord blood cells. Participants with an available qualified autologous cord blood unit will receive autologous cells. Participants without a suitable autologous cord blood unit available will receive an unrelated matched donor cord blood unit from the Carolina’s Cord Blood Bank.

The study lasts one year for each participant. Participants do not need to live locally but need to come to the Duke Center for Autism and Brain Development and the McGovern-Davison Children’s Health Center (CHC) for study visits at baseline and 6 months. Each study visit will be 3 days long. Parents or caregivers will also be required to remotely complete report measures in order to track changes throughout the year.

If located in North Carolina and the surrounding areas, please contact 919-681-9730 or autismresearch@dm.duke.edu. If located outside of North Carolina and surrounding areas, please contact 1-844-800-CORD or DukeACTstudy@dm.duke.edu for more information.

It may be several weeks before you are contacted.  Families are contacted in the order in which they inquire about the study.

ClinicalTrials.gov Identifier: NCT02847182

IRB # Pro00070514

Children ages 2-7 years with a clinical diagnosis of ASD.
Enrollment status
Tuesday, September 6, 2016