Tissue-provider AlloSource said this week it completed production of investigational bioengineered blood vessels designed for Humacyte‘s Phase III clinical trial exploring the use of the vessels to improve vascular access for hemodialysis patients with end-stage renal failure.
The trail aims to compare the efficacy of the bioengineered human-tissue vessels to current synthetic vessels made from expanded polytetrafluoroethylene, Centennial, Colo.-based Allosource said.
“AlloSource’s partnership with Humacyte supports our focus on regenerative medicine. 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 prez & CEO Thomas Cycyota said in a press release.
The 2 companies originally partnered in 2013, with AlloSource serving as the sole manufacturing partner for Humacyt’es blood vessels.
The Humacyl vessels are produced using donated human vascular cells that are decellularized, producing investigational human vascular vessels with the potential to be implanted in a broad range of patients, the company said.
In March, Humacyte said that the FDA granted its investigational human acellular vessel, Humacyl, the regenerative medicine advanced therapy designation. The regulatory win means that the FDA will expedite its review of the HAV for patients in need of life sustaining hemodialysis.
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