Bioengineered Vein Implanted

For the first time, a team of doctors at Duke University Hospital have created a bioengineered blood vessel and transplanted it into the arm of a patient with end-stage kidney disease. This procedure, the first U.S. clinical trial to test the safety and effectiveness of the bioengineered blood vessel is a milestone in the field of tissue engineering. 

The new vein is an off-the-shelf human cell-based product with no biological properties that would cause organ rejection. Using technology developed at Duke University Hospital and at a spin-off company called Humacyte, the vein is engineered by cultivating donated human cells on a tubular scaffold to form a vessel.

Originally, the researchers tried to develop veins using a person’s own cells to seed the scaffolding, thereby reducing the risk that the patient’s body would reject the implanted tissue. However growing personalized veins took too much time and ruled out mass production.

In pre-clinical tests, the veins have performed better than other synthetic and animal-based implants. “This is a pioneering event in medicine,” said Jeffrey H. Lawson, M.D, PhD, a Vascular Surgeon and Vascular Biologist at Duke Medicine who helped develop the technology and performed the implantation.

Clinical trials to test the new veins began in Poland in December with the first human implantation. FDA recently approved a Phase 1 trial involving 20 kidney dialysis patients in the U.S followed by a safety review. Duke researchers enrolled the first U.S patient in a trial and serve as study leaders.

The focus for the initial trial is to implant the vessels in easily accessible sites in the arms of kidney hemodialysis patients. More than 350,000 people in the U.S require hemodialysis, which often necessitates a graft to connect an artery to a vein to speed blood flow during treatments.

If the bioengineered veins prove beneficial for hemodialysis patients, the researchers ultimately aim to develop a readily available and durable graft for heart bypass surgeries performed on nearly 400,000 people in the U.S every year to treat blocked blood vessels in the limbs.

“The bioengineered blood vessel technology is a new paradigm in tissue engineering,” said Laura Niklason, MD, PhD, Co-Founder of Humacyte and Professor of Biomedical Engineering at Yale University. “This technology is a key step for patients with end-stage renal disease and can potentially avoid surgical interventions and hospitalizations.”