Autism and Newborn Stem Cells: FDA Green-Lights Groundbreaking Clinical Trial
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 one in 88 children in the U.S. are diagnosed with autism spectrum disorders each year. The clinical trial will evaluate the ability of an infusion of cord blood stem cells to help improve language and behavior.
The study will enroll 30 children between the ages of two and seven, who meet the inclusion criteria for the study. Enrolled participants will receive two infusions—one of the child’s 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. If you would like to be contacted regarding trial participation, please sign up here.
"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, director of pediatric neurology at Sutter Medical Center and principal study investigator. "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."
For more information on this clinical trial sign up here.