Autism & Cord Blood Stem Cells:
Phase II Research Study Underway

Duke University Medical Center is currently conducting a Phase II clinical research trial using a cord blood infusion for children with Autism Spectrum Disorder (ASD). The goal of the study is to to determine if there is a benefit from an intravenous infusion of autologous (the child’s own) or unrelated donor cord blood to children with ASD.

This clinical trial offers hope for families affected with ASD, and over a dozen ViaCord families have requested access to their banked cord blood in order to participate in the clinical research trial.

Autism Overview

According to the CDC 1 in 68 children are identified with Autism Spectrum Disorder (ASD). Autism is a disorder that affects the brain’s normal development of social and communication skills and appears in the first 3 years of life.103 ASD is a range of disorders characterized by “persistent deficits in social communication and social interaction across multiple contexts and restricted, repetitive patterns of behavior, interests, or activities.” Although the exact causes of Autism Spectrum Disorder are still unknown, research suggests that both genes and environment play important roles.102

 Duke University Medical Center Moves into Phase II Clinical Research Study Using Cord Blood Stem Cells

After completing a Phase I safety study in August, Duke University Medical Center has moved into a Phase II clinical research study of cord blood infusion for children with Autism Spectrum Disorder (ASD).The goal of the Phase II study will be to determine if there is a benefit from an intravenous infusion of autologous (the child’s own) or unrelated donor cord blood to children with ASD.

Study details

To be considered for inclusion in this study:

  • Your child must have a confirmed diagnosis of Autism Spectrum Disorder.
  • Your child must be between 2-7 years of age.
  • You must be able to travel with your child to Duke University Medical Center in North Carolina, U.S. on 2 separate occasions for 4 days each, 6 months apart.

Duke will evaluate if a patient is eligible and make the ultimate selection of candidates for this study.

To learn more about this study and determine if it may be an option for your child, please complete the following steps:

  • Learn more about the study and requirements for participation including complete inclusion/exclusion criteria here on clinicaltrials.gov
  • Contact the Duke study team at the following email address: DukeACTstudy@dm.duke.edu
  • If Duke requests your cord blood information, complete and submit the ViaCord Release Form – which you can access here.

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