Friday, June 7, 2013

Bioengineered Vein Successfully Implanted

Kidney dialysis patient first in U.S. to receive blood vessel grown in laboratory

DURHAM, N.C. – In a first-of-its-kind operation in the United States, a team of doctors at Duke University Hospital helped create a bioengineered blood vessel and transplanted it into the arm of a patient with end-stage kidney disease.

The 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 and at a spin-off company it started called Humacyte, the vein is engineered by cultivating donated human cells on a tubular scaffold to form a vessel. The vessel is then cleansed of the qualities that might trigger an immune response. 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. “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.”

Clinical trials to test the new veins began in Poland in December with the first human implantations. The U.S. Food and Drug Administration recently approved a phase 1 trial involving 20 kidney dialysis patients in the United States, followed by a safety review. Duke researchers enrolled the first U.S. patient and serve as study leaders.

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