In the field of cardiovascular regenerative medicine, clinical trials are now underway to test various approaches that use ‘off-the-shelf’ engineered tissues to treat patients with serious vascular conditions. In this talk, Dr. Laura Niklason discusses her team’s approach to vascular engineering which involves seeding allogeneic vascular cells onto a degradable substrate to culture vascular tissues in a biomimetic bioreactor. After a period of 8-10 weeks, engineered tissues are then decellularized to produce an engineered extracellular matrix-based graft. Using allogeneic cells for graft production eliminates the need for harvesting a biopsy from the patient and requires no patient-specific culture time. These grafts are currently being tested in a Phase III clinical trial in Europe and in the US. Early experience supports the potential utility of this novel tissue-engineered vascular graft to care for patients suffering from vascular trauma, kidney failure on dialysis, and other vascular diseases.
Dr. Niklason is the founder, president, and CEO of Humacyte, a regenerative medicine company launched in 2005 while Niklason was a professor at Duke University. Humacyte is currently performing Phase III trials of engineered blood vessels for dialysis access and for treatment of vascular trauma. Dr. Niklason’s scientific career has focused primarily on regenerative strategies for cardiovascular and lung tissues. She has been inducted into the National Academy of Inventors, the National Academy of Medicine, and the National Academy of Engineering. In 2017, Fortune Magazine named her as one of 34 leaders who are changing health care. Niklason earned her doctorate degree in biophysics from the University of Chicago and her MD degree from the University of Michigan. She completed her medical training in anesthesiology and critical care medicine at the Massachusetts General Hospital. Dr. Niklason was a professor at Duke University for seven years before moving to Yale University, where she remained for 16 years before taking the CEO position at Humacyte.