New U Of M Study 'Is A Huge Step Forward In Ped's Heart Research'
MINNEAPOLIS (WCCO) - The University of Minnesota published a new study Wednesday showing for the first time that lab-created heart valves were capable of growth within the recipient.
The heart valves were implanted in young lambs for a year and showed reduced calcification and improved blood flow function compared to animal-derived valves currently used in western medicine.
Researchers say that if confirmed in humans, the new heart valves could prevent the need for repeated valve replacement surgeries in children born with congenital heart defects.
The lab-created valves can also be stored for at least six months allowing surgeons an "off the shelf" option for treatment.
The study was published in Science Translation Medicine, a journal by the American Association for the Advancement of Science. According to the journal the valve-making procedure has been patented and licensed to the University of Minnesota startup company known as Vascudyne, Inc.
Robert Tranquillo, the senior researcher on the study and a University of Minnesota Professor of Biomedical Engineering says the finding is a huge step forward in pediatric heart research.
"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," said Tranquillo.
In the study, Tranquillo and his colleagues used a hybrid of tissue engineering and regenerative medicine to create the growing heart valves.
To develop parts of the valve the team combined the donor sheep skin cells in a gelatin-like material in the form of a tube and provided nutrients necessary for cell growth. A series of construction with said tubes and cleaning of the final product followed in its creation.
"After these initial steps, it looked like a heart valve, but the question then became if it could work like a heart valve and if it could grow," said Tranquillo. "Our findings confirmed both."
The valves were then implanted into the pulmonary artery of the lambs and after 52 weeks, the valves regenerated and increased in size to the physiologically normal valve.
Tranquillo says the next step is implanting their valves directly into the right ventricle of the heart to mimic the most common surgical repair. Once this is accomplished the researchers can begin the process of requesting approval from the FDA for human clinical trials over the next few years.
"If we can get these valves approved someday for children, it would have such a big impact on the children who suffer from heart defects and their families who have to deal with the immense stress of multiple surgeries," Tranquillo said. "We could potentially reduce the number of surgeries these children would have to endure from five to one. That's the dream."
