AlloSource, a nonprofit cellular and tissue network, has announced the distribution of investigational bioengineered blood vessels for use in phase 3 clinical studies. The first shipment will be used in a trial investigating the potential of the blood vessels, manufactured in partnership with Humacyte, to improve vascular access for hemodialysis patients with end-stage renal disease (ESRD). The study will compare the efficacy of the bioengineered vessels with that of the current standard of care, synthetic blood vessel replacement with polytetrafluoroethylene (PTFE) grafts.
AlloSource and Humacyte entered into a strategic partnership in 2013, with AlloSource serving as the sole manufacturing partner for Humacyte’s blood vessels. The bioengineered vessels are produced using donated human vascular cells, which 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, according to AlloSource.
The phase 3 HUMANITY trial will be conducted at approximately 35 sites in the United States, Europe, and Israel with 350 evaluable subjects, making it the largest study of any bioengineered vascular tissue to date. The study’s primary objective will be to compare the secondary patency of the bioengineered blood vessel with that of a PTFE graft when used as a conduit for hemodialysis. The study population will include patients with ESRD who require hemodialysis and are not candidates for fistula, thus making them candidates for implantation of an arteriovenous graft for dialysis access. The rate of access-related infections with the bioengineered graft compared with that of the PTFE graft will also be assessed. The patients will be followed for up to 76 months from enrollment through the completion of final data collection.
Humacyte submitted an investigational new drug application to the FDA in 2012 for a multicenter U.S. clinical trial designed to assess the safety and performance of the bioengineered blood vessels in providing vascular access for dialysis in patients with ESRD. In 2014, the FDA gave the technology a fast-track designation. Fast-track status means that the agency will help facilitate the development and review of drugs and biologics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.