Duke University Releases Results on Phase I Autism Trial
Duke University has released the results from its preliminary, phase I study on the safety of treating children with autism with an intravenous infusion of their own umbilical cord blood.
Dr. Kurtzberg is the lead on Duke University's autism trials
These initial results showed great promise: It found that among 25 children ages 2–5, more than two-thirds appeared to show improvements in speech, socialization, and eye contact as reported by parents and assessed by researchers. We previously shared early news of these findings, including videos of some of the improvements seen in participating autistic children. We've been closely following this promising study, also reporting on it here and here.
“We are cautiously optimistic about these early findings,” said Duke Pediatric Bone Marrow Transplant Specialist Joanne Kurtzberg, MD, who is a principal investigator of the study.
Phase II Trial Underway
The researchers are now leading a larger, controlled Phase II clinical trial to determine whether the initial suggestion of benefit to children with autism spectrum disorder can be replicated.
Initial screening for the trial is complete, and the research team is no longer seeking additional subjects. (Note to parents: This does not apply to children who have already registered for screening and are still being evaluated for enrollment in the trial.) The trial is expected to be complete in 2019.