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Children’s Minnesota to help prepare clinical trials of lab-created pediatric heart vessels that grow with the patients

Research team led by the University of Minnesota recently awarded $3.7 million grant

A Children’s Minnesota surgeon is part of a University of Minnesota-led research team recently awarded a $3.7 million grant to prepare for human clinical trials of artificial, bioengineered pediatric blood vessels that grow with a patient.

The funding is from the Department of Defense’s Congressionally Directed Medical Research Programs, which aims to foster and invest in groundbreaking research that will lead to cures or improvements in patient care.

Currently, children with congenital heart defects who receive heart vessel grafts often outgrow them and require multiple surgeries to have larger vessels implanted. If the trial is successful, the bioengineered vessel grafts could prevent the need for multiple surgeries.

“This novel graft could allow for the smallest of children to get new blood vessels that would grow with them, avoiding repeated procedures and surgeries that they normally would need as they grow,” said Dr. Robroy MacIver, congenital heart surgeon and surgical director of the Heart Failure and Heart Transplant program at Children’s Minnesota and member of the research team since 2014.

“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 at the University of Minnesota.

Robroy H. MacIver MD, MPH
Robroy H. MacIver MD, MPH

Preparing clinical trials

Children’s Minnesota and Boston Children’s Hospital will help design the first human clinical trial and implant the vessels if the trial receives approval from the Food and Drug Administration (FDA).

“Any trial of a new technology specifically centered around children is exciting because they don’t happen that often. New technologies often are made for adults, and then refigured to work in children,” described Dr. MacIver.

The vessel-like tubes will be manufactured by Vascudyne, a University of Minnesota startup company. The tubes will be grown with a donor’s skin cells in the lab. The cells are removed to reduce the chance of rejection. Once implanted, the tube is repopulated by the recipient’s own skin cells allowing it to grow.

To prepare for the human clinical trial, the team will continue evaluating the current research, which Dr. MacIver says is promising. If the research continues to go well, the team will meet with the FDA to move forward with a clinical trial in select patients. If all goes well, the trial could begin within approximately 18 months, according to MacIver.