Doctors at Duke University Hospital have announced the first successful implant of a bioartificial blood vessel created in the laboratory by the company Humacyte. The first patient to receive the implant was a man of 62 years with kidney failure who, after two hours of surgery, received a vein graft on 5 June.
The vein was designed using donated human cells growing on a scaffold tube to form a container that is specially treated to clean all the qualities that might trigger an immune response rejection.
"In pre-clinical testing, the veins have performed better than other synthetic implants and those of animal origin. This is a pioneering event in medicine, "said Jeffrey H. Lawson, MD, PhD, a vascular surgeon and vascular biologist at Duke University. The Food and Drug Administration (FDA) recently approved a phase 1 trial involving 20 patients on dialysis in the United States. Initial testing focuses on the implantation of blood vessels in a convenient place in the arms of renal patients on hemodialysis.
Initially, the researchers sought to develop veins using a person's own cells growing in a scaffold, reducing the risk of implanted tissue rejection in the patient's body. But because of the long time required for mass production this method was discarded, so that investigators changed course to develop a universal product using donated human tissue.
Million people worldwide require hemodialysis which often needs a graft to connect an artery to a vein to accelerate the flow of blood during treatment. Current options have drawbacks as synthetic vascular grafts are prone to clotting, causing frequent hospitalizations. This graft also could be used for coronary bypass or to replace blocked vessels in limbs. With no doubt it is a great advance in medicine that promises many benefits.
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