Centennial, Colo. – September 12, 2017 — AlloSource, one of the nation’s largest providers of cartilage, bone, skin, soft-tissue and cellular allografts for use in surgical procedures to advance patient healing, today announced a major milestone in its partnership with Humacyte. AlloSource completed production of investigational bioengineered blood vessels for Humacyte’s Phase III clinical trial.
This Phase III clinical trial is investigating the potential of Humacyte’s HUMACYL® blood vessels to improve vascular access for hemodialysis patients with end-stage renal disease. The clinical trial compares the efficacy of Humacyte’s bioengineered human-tissue vessels to the current standard of synthetic vessels manufactured from expanded polytetrafluoroethylene (ePTFE).
“AlloSource’s partnership with Humacyte supports our focus on regenerative medicine,” said Thomas Cycyota, AlloSource president and CEO. “Our organizations share a deep commitment to developing products that provide patients life-saving or life-improving potential. We look forward to the possibilities these vessels offer to that mission, and to our continued long-term efforts with cellular technology.”
AlloSource and Humacyte’s strategic partnership began in 2013, with AlloSource serving as the sole manufacturing partner for Humacyte’s clinical blood vessels. HUMACYL vessels are produced using donated human vascular cells that are decellularized to remove the donor cells from the newly created vessels. This process results in investigational human vascular vessels with the potential for implantation into nearly any patient at the time of medical need.
The World Economic Forum recently selected Humacyte as a 2017 Technology Pioneer, an award designated for organizations that are poised to have a significant impact on business and society. Earlier this year, the United States Food and Drug Administration (FDA) granted HUMACYL the Regenerative Medicine Advanced Therapy designation. This designation means the FDA will help facilitate the efficient development and expedited review of HUMACYL for vascular access to patients in need of life-sustaining hemodialysis.