Groundbreaking discovery could potentially reduce multiple pediatric heart valve replacement surgeries.

If confirmed in humans, these new heart valves could prevent the need for repeated valve replacement surgeries in thousands of children born each year with congenital heart defects. The valves can also be stored for at least six months, which means they could provide surgeons with an «off the shelf» option for treatment.

The study was published today in Science Translational Medicine, an interdisciplinary medical journal by the American Association for the Advancement of Science (AAAS). The valve-making procedure has also been patented and licensed to the University of Minnesota startup company Vascudyne, Inc. (Stillwater, Minn.).

«This is a huge step forward in pediatric heart research,» said Robert Tranquillo, the senior researcher on the study and a University of Minnesota professor in the Departments of Biomedical Engineering and the Department of Chemical Engineering and Materials Science. «This is the first demonstration that a valve implanted into a large animal model, in our case a lamb, can grow with the animal into adulthood. We have a way to go yet, but this puts us much farther down the path to future clinical trials in children. We are excited and optimistic about the possibility of this actually becoming a reality in years to come.»

Currently, researchers have not been able to develop a heart valve that can grow and maintain function for pediatric patients. The only accepted options for these children with heart defects are valves made from chemically treated animal tissues that often become dysfunctional due to calcification and require replacement because they don’t grow with the child. These children will often need to endure up to five (or more) open heart surgeries until a mechanical valve is implanted in adulthood. This requires them to take blood thinners the rest of their lives.

In this study, Tranquillo and his colleagues used a hybrid of tissue engineering and regenerative medicine to create the growing heart valves. Over an eight-week period, they used a specialized tissue engineering technique they previously developed to generate vessel-like tubes in the lab from a post-natal donor’s skin cells. To develop the tubes, researchers combined the donor sheep skin cells in a gelatin-like material, called fibrin, in the form of a tube and then provided nutrients necessary for cell growth using a bioreactor.

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