Humacyte said today that it landed a $14.1 million award from the California Institute for Regenerative Medicine to support a clinical trial comparing its human acellular vessel, Humacyl, to arteriovenous fistulas – the traditional way to create vascular access in patients who need hemodialysis.
The Research Triangle Park, N.C.-based company said it plans to evaluate Humacyl as a conduit for hemodialysis in a group of patients with end-stage renal disease who need renal replacement therapy.
“This significant and incremental investment from CIRM further validates the potential of our bioengineered human acellular vessel’s capabilities as a more durable and safe vascular access option for patients requiring dialysis treatment,” CMO Dr. Jeffrey Lawson said in prepared remarks.
“Based on the early promising signals from our Phase II study results published in The Lancet last year, and the positive data that we expect from our ongoing Phase III trials comparing the Humacyl to ePTFE grafts, we envision broader opportunities for Humacyl beyond an alternative to synthetic grafts, starting with this newest study comparing our product to arteriovenous fistulas.”
Humacyte said it expects results from its pivotal Humanity trial later next year. From there, it hopes to submit a biological license application to the FDA for its human acellular vessel.
Earlier this year, Humacyte won the regenerative medicine advanced therapy designation from the FDA, helping to speed up the development and review of Humacyl.
“CIRM recognizes the challenges faced by more than 465,000 patients in the U.S. undergoing hemodialysis procedures with few effective vascular access options available to them, and we deeply appreciate this significant support,” chairman & CEO Carrie Cox added.
“This additional funding enables Humacyte to explore the use of our innovative technology to treat a broader range of patients suffering from ESRD that need hemodialysis as a life-saving treatment. With Humacyl, we hope to realize our vision to provide better healthcare options for patients through a more durable, biological alternative, while lowering the costly and deadly risk of infection and higher rates of abandonment of current synthetic alternatives.”