ViaCord Launches Phase I Clinical Trial with Leading Academic Medical Center to Study Impact of Cord Blood Infusion in Children with Autism
ViaCord, PerkinElmer's family cord blood and tissue preservation business, announced the launch of a phase I clinical trial at Duke University Medical Center to investigate the safety of autologous umbilical cord blood infusion in children with Autism Spectrum Disorder (ASD).
According to a recent report1 by the Centers for Disease Control and Prevention (CDC), the number of U.S. children with ASD has sharply increased to 1 in 68 -- a 30 percent increase from two years ago, when the CDC estimated that 1 in 88 children had this disorder.
"We are pleased to collaborate with Duke University Medical Center by sponsoring this important study to determine the safety of cord blood for potentially treating this prevalent disorder facing children worldwide," said Morey Kraus, Chief Scientific Officer, ViaCord. "Cord blood has not traditionally been closely evaluated as a possible safe treatment option for ASD. Aligning our efforts with the experts at a leading medical research center underscores our commitment to improving the lives of children and families struggling with ASD."
The single site Phase 1 safety study includes 20 subjects and is designed to objectively evaluate safety and multiple measures of social behavior and irritability in young children diagnosed with ASD. Children ages 24-72 months of age with a confirmed diagnosis of ASD and a banked autologous unit of umbilical cord blood of adequate size and quality may be eligible to participate.
Researchers will assess the feasibility of various outcome measures to determine which measure(s) can be used as primary and secondary endpoints for a future randomized phase II clinical trial.
"We are excited to conduct this important study in children with Autism Spectrum Disorder. We hope to learn whether cord blood infusions are safe and to define the best tests to use to study the effects of cord blood in future studies", said Joanne Kurtzberg, MD, Director, Carolinas Cord Blood Bank and Pediatric Blood and Marrow Transplant Program, Chief Scientific Officer, Robertson Clinical and Translational Cell Therapy Program, Duke University.
More information on the Autism clinical trial at Duke University Medical Center is available by contacting firstname.lastname@example.org or 844-800-2673.
Cord blood is also being used in the Duke Translational Medicine Institute's Cerebral Palsy clinical trial, which has recently completed enrollment. Duke's researchers have accepted numerous cord blood units from ViaCord for this study, which investigates the potential benefits of autologous reinfusion of cord blood stem cells for children with cerebral palsy.
Cord blood stem cells have been used in the treatment of nearly 80 diseases, and more than 30,000 treatments using donor cord blood have been conducted worldwide using cord blood stem cells. ViaCord has released stem cells for the treatment of diseases ranging from acute lymphoblastic leukemia, thalassemia major and sickle cell disease. ViaCord has preserved the umbilical cord stem cells of more than 300,000 newborns.
ViaCord's family cord blood and cord tissue services also offer expectant families the opportunity to bank their baby's umbilical cord blood and tissue for potential medical use by the child or a related family member. Through its Sibling Connection Program, ViaCord also provides the opportunity for expectant parents, who have an eligible child in need of a transplant, to receive cord blood and cord tissue stem collection, processing and five years of storage, at no cost. Please visit www.viacord.com for more information.
1 Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2010; March 28, 2014: http://www.cdc.gov/mmwr/preview/mmwrhtml/ss6302a1.htm?s_cid=ss6302a1_w
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