Tuesday May 24, 2016 0 comments
CENTENNIAL -- AlloSource, one of the nation's largest providers of cartilage, cellular, bone, skin and soft-tissue allografts for use in surgical procedures and wound care to advance patient healing, today announced the distribution of investigational bioengineered blood vessels for Humacyte's Phase III clinical trials.
AlloSource said the first shipment of vessels will be used in the upcoming Phase III clinical trial, which will investigate the potential of Humacyte's blood vessels to improve vascular access for hemodialysis patients with end-stage renal disease.
The clinical trial will compare the efficacy of Humacyte's vessels to the current standard of care, synthetic blood vessel replacement with Polytetrafluoroethylene (PTFE) grafts.
"We are honored to collaborate with Humacyte to produce this incredible technology," said Thomas Cycyota, AlloSource president and CEO.
"As we celebrate the distribution of vessels for the clinical trial, we are grateful for the tissue donors who made this possible and we are energized about the positive medical impact of Humacyte's work."
AlloSource and Humacyte entered into a strategic partnership in 2013, with AlloSource serving as the sole manufacturing partner for Humacyte's blood vessels. The investigational bioengineered vessels are produced using donated human vascular cells that are decellularized to remove the donor identity from the newly created vessels.
This process results in the production of investigational human vascular grafts with the potential for implantation into any patient at the time of medical need.
"The first distribution of vessels for our Phase III clinical trials is an exciting milestone for both Humacyte and AlloSource," said Carrie S. Cox, Humacyte chairman and CEO.
"We look forward to the results of this trial and this product's potential to not only provide physicians with a new solution, but also provide patients with a progressive, life-saving option."
Humacyte submitted an Investigational New Drug application to the U.S. Food and Drug Administration (FDA) in 2012 for a multi-center U.S. clinical trial to assess the safety and performance of Humacyte's investigational bioengineered vessel to provide vascular access for dialysis in End-Stage Renal Disease (ESRD) patients.
In 2014, the FDA gave the technology a fast-track designation, meaning the FDA will help facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.