Autism and Cord Blood Stem Cells: FDA Green-Lights Groundbreaking Clinical Trial

CBR is helping lead stem cell medicine research with groundbreaking clinical trials. Sutter Neuroscience Institute in Sacramento, California, and Cord Blood Registry are launching the first FDA-regulated, clinical trial to assess the use of a child’s own cord blood stem cells to treat select patients with autism. This first-of-its-kind placebo controlled study is important because 1 in 88 children* in the U.S. is diagnosed with an autism spectrum disorder. The clinical trial will evaluate the ability of an infusion of cord blood stem cells to help improve language and behavior. Similar to three other clinical trials looking at the use of cord blood stem cells as a potential therapy for cerebral palsy, hearing loss and traumatic brain injury, CBR families have exclusive access to this trial.

“Autism is a growing public health issue. This study goes beyond treating symptoms to understanding how stem cells may initiate repair or healing in chronic conditions like cerebral palsy or autism,” stated Dr. Chez, principal study investigator and director of pediatric neurology for the Sutter Medical Center Neuroscience Institute. “We have evidence to suggest that certain children with autism have dysfunctional immune systems that may be damaging or delaying the development of the nervous system,” continued Dr. Chez. “Cord blood stem cells may offer ways to modulate or repair the immune systems of these patients, which would also improve language and some behavior in children who have no obvious reason to have become autistic.”

The study will enroll 30 children with a diagnosis of autism between the ages of two and seven, who meet the inclusion criteria for the study. Enrolled participants will receive two infusions—one of their own cord blood stem cells and one of a placebo—over the course of 13 months. Both the participants and the lead investigators will be blinded from knowing the content of each infusion. To ensure consistency in cord blood stem cell quality, CBR is the only family stem cell bank providing units from clients for the study.

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*http://www.cdc.gov/ncbddd/autism/data.html