Lab-grown blood vessel receives clinical trial

A team of doctors in the US have created a bioengineered blood vessel and successfully transplanted it into the arm of a patient with end-stage kidney disease, in the first ever operation of its kind the US.

Experts at Duke University Hospital, who carried out the procedure, referred to it as a "milestone" in the field of tissue engineering, as the new vein is a human cell-based product with no biological properties that would lead to organ rejection.  

The process, which used technology developed at Duke University, involves engineering the vein by cultivating donated human cells on a tubular scaffold to form a vessel, which is then cleansed of any qualities that could trigger an immune response.

In pre-clinical tests, the veins performed better than other synthetic and animal-based implants, with clinical human trials to test the new veins beginning in Poland in December.

The US Food and Drug Administration (FDA) then approved a phase 1 trial involving 20 kidney dialysis patients in the US, followed by a safety review.

Dr Jeffrey Lawson, a vascular surgeon and vascular biologist at Duke Medicine who helped develop technology and performed the implantation, said it is a pioneering event in the history of medicine.

"It's exciting to see something you've worked on for so long become a reality. We talk about translational technology – developing ideas from the laboratory to clinical practice – and this only happens where there is the multi-disciplinary support and collaboration to cultivate it," he added.

Initially, scientists sought to develop veins using a person’s own cells to seed the scaffolding, thereby lowering the risk that the patient’s body would reject the implanted tissue, but this was time consuming and led them to their eventual discovery and result.

Dr Laura Niklason, co-founder of Duke research subsidiary Humacyte and a former faculty member at the university, said the first patient was a 62-year-old man with renal failure, but other patients may now be set to benefit.

"At the end of the process, we have a non-living, immunologically silent graft that can be stored on the shelf and used in patients whenever they need it," she concluded.

Posted by Fiona Griffiths