The new funding is through the U.S. Dept. of Defense’s Congressionally Directed Medical Research Programs. It will go toward the preparation needed for a human clinical trial of artificial, bioengineered blood vessels that grow with a patient. If the trial is successful, the vessel grafts could be used to prevent repeated surgeries in children with congenital heart defects.
Patients who have heart defects at birth can often grow out of current vessel grafts and need to have larger vessels implanted several times while still growing, according to the researchers.
“This grant is a major step forward and will allow us to do everything that’s necessary to get to day one of a first clinical trial where we would implant one of our lab-created blood vessels into an infant with a heart defect,” said Robert Tranquillo, a Distinguished McKnight University professor in the department of biomedical engineering and the department of chemical engineering and materials science.
A University of Minnesota startup company, Vascudyne, will manufacture the vessel-like tubes to prepare for the clinical trial. The tubes will be grown using a donor’s skin cells in a lab. The cells are then removed to reduce the chance of rejection. Once the tube is implanted, it will be repopulated by the recipient’s own skin cells to allow it to grow.
Funding from the grant will cover any remaining pre-clinical studies needed before proceeding to the human clinical trials. Tranquillo and Zeeshan Syedain, Vascudyne’s chief scientific officer and a senior research associate, will partner with Experimental Surgical Services in the University of Minnesota Medical School to test the tubes in lambs.
“This research could have a major impact for children with heart defects. Instead of three, four or even five surgeries or interventions during their childhood, children would only need one surgery,” Tranquillo said. “This would substantially reduce trauma and risk for children and the overwhelming health care costs for families.”
The study is a replication of a 2016 study when lamb’s cells repopulated tubes implanted into the main pulmonary artery and proved that the tubes grew in size with the lamb.
Two lambs have been implanted with the tubes in the current clinical study. The tubes were placed in the left pulmonary artery branch that has grown with the lambs into adulthood.
The research team is partnering with pediatric cardiac surgeons at Children’s Minnesota and Boston Children’s Hospital to help understand the pre-clinical data and design the first human clinical trial. If successful, Tranquillo hopes to move toward clinical trials with similar research involving bio-artificial pediatric heart valves that grow with a child.