The Mayo Clinic has launched the nation’s first stem cell clinical trial for pediatric congenital heart disease.
The trial is designed to determine whether stem cells taken from umbilical cord blood can help children with a rare defect — hypoplastic left heart syndrome (HLHS) — in which the left side of the organ is critically underdeveloped.
"We want to see if these stem cells will increase the volume and strength of the heart muscle to give it greater durability and power to pump blood throughout the body," said Harold Burkhart, M.D., a pediatric cardiovascular surgeon with the Mayo Clinic Children's Center.
The trial, which will include 10 infants with HLHS, aims to test the safety and feasibility of delivering a personalized stem cell-based therapy to children affected by the disorder.
Currently, babies born with HLHS must undergo a heart transplant or three surgeries in the first few years of life to redirect blood flow. For the Mayo study, stem cells from newborns with HLHS will be isolated from the umbilical cord following birth and then injected into their heart muscles at 4 to 6 months of age. Nearly 1,000 babies are born with HLHS each year in the U.S., the Centers for Disease Control and Prevention estimates.
"The care of these children with HLHS has been continuously improving since the first surgical procedure became available three decades ago, yet cardiac transplantation continues to be the limiting factor for far too many individuals," noted Timothy Nelson, M.D., director of the Todd and Karen Wanek Family Program for HLHS in Mayo Clinic's Center for Regenerative Medicine. "Applying stem cell-based regeneration may offer a viable solution to help these children develop new tissues and grow stronger hearts."
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