Partnership to create bioengineered blood vessels
Humacyte Inc., a regenerative medicine company that’s developing investigational bioengineered blood vessels, has entered into a long-term strategic manufacturing partnership with AlloSource.
AlloSource is a non-profit provider of skin, bone and soft tissue allografts and the world's largest processor of cellular bone allografts. According to the agreement, the company will become the sole manufacturer of Humacyte's investigational bioengineered blood vessels.
Humacyte’s first investigational bioengineered vessel is being developed with the goal of approval for use in patients with chronic kidney disease. Patients that progress to end-stage renal disease require kidney replacement therapy.
Last year, the company submitted an investigational new drug application to the U.S. Food and Drug Administration for a multi-center U.S. clinical trial involving up to 20 patients across three sites to assess safety and performance of Humacyte's investigational bioengineered vessel to provide vascular access for dialysis in end-stage renal disease patients.
That clinical trial is now ongoing, with the first investigational bioengineered vessel in the U.S. implanted in the arm of a kidney dialysis patient at Duke University Hospital in June. This technology could have the potential to help reduce or avoid surgical interventions and hospitalizations for patients with end-stage renal disease.