The US Food and Drug Association has approved the first clinical trial of using umbilical cord stem cells in treating autism. The trial will be launched by Sutter Neuroscience Institute in Sacramento, California, and Cord Blood Registry and will be aimed at evaluating efficacy of transplantation of autologous umbilical cord stem cells on autistic children. In particular, impact on language and behavior will be assessed. The changes will be measured before and six months after the treatment and compared to draw conclusions on the therapy efficacy.
This will be the first placebo-controlled study and it will enroll 30 children aged two to seven meeting the criteria for participants’ selection. Over the course of 13 months, Children will receive two infusions – one of the child’s own stem cells from cord blood stored at birth and one of a placebo. This will be double blind test – neither participants nor the lead investigators will know what is infused each time. To ensure similar quality of all transplants, Cord Blood Registry will be the only cord blood bank providing stem cells for the study.
The trial is of extreme importance because one in 88 children is diagnosed with ADS – autism spectrum disorders – each year in the US. The study will focus not on the symptoms, but on understanding the curative role of stem cells in such conditions as autism. The researchers suggest that some autistic children have dysfunctional immune system that may damage or delay the nervous system development. They assume that stem cell therapy could help repair or modulate the immune system in these patients which would bring language and behavior improvements.