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.

10 Comments on “Autism & Cord Blood Stem Cells:
Phase II Research Study Underway

  1. I have a high functioning autistic 15 year old. He has a brother and sister that are twins that we have their cord blood stored. Would you please keep us posted on any trials regarding his age group.

  2. Hi can i participate in this trial for my 6 years old autistic son with the cord blood from his sister?

    • Hi Aimek– Thank you for reaching out. At this time, autism research is not using sibling cord blood. However, we do recommend contacting Duke at the following email address to be notified of future studies: cordbloodtherapyinfo@dm.duke.edu. Clinicaltrials.gov is also a great resource to use to stay up to date on all the latest cord blood research.

  3. Son is 11, diagnosed with ASD. No cord blood saved.
    Sister is 9 yrs old, non-ASD. cord blood saved.

    Could her cord blood be beneficial to her brother, with less side effects, as a sibling?

    • Hi Ray – Thank you for reaching out. At this time, autism research is not using sibling cord blood. However, we do recommend contacting Duke at the following email address to be notified of future studies: cordbloodtherapyinfo@dm.duke.edu. Clinicaltrials.gov is also a great resource to use to stay up to date on all the latest cord blood research.

  4. Hi,
    About 6 years ago, when my son was 5 years old, I spoke to Dr Joanne Kurtzberg and asked her to do such a study. Now, although my son has made much progress, he still has his challenges. When will you be willing to expand the age criteria of the study? I would like to enroll my 11 year old in it, before it’s too late for his brain to make as much gains.

  5. My son will be 14 in July. he has ASD and I would love to participate in a trial for older kids
    Any such programs in the near future ? Any help is deeply appreciated

    • Hi Vidya – Thank you for reaching out! At this time, trials are not recruiting older kids. However, we recommend contacting Duke at the following email address to be notified of future studies: cordbloodtherapyinfo@dm.duke.edu. Clinicaltrials.gov is also a great resource to use to stay up to date on all the latest research using cord blood.

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