New hemodialysis therapy receives FDA Regenerative Medicine Advanced Therapy expedited review designation
HUMACYL®, an investigational human acellular vessel, is currently undergoing a Phase III trial in 350 patients with kidney failure.
A novel treatment that improves long-term vascular access for kidney dialysis has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
HUMACYL®, from Humacyte (NC, USA), received the FDA’s Fast Track Designation in 2014 and seeks to establish more durable long-term vascular access. Over 400,000 patients suffering from end-stage renal disease undergo hemodialysis and it is hoped that this new treatment will decrease vascular access complications and may result in more favorable morbidity and mortality outcomes.
“Being one of the first companies to receive the Regenerative Medicine Advanced Therapy Designation from the FDA is an honor and a testament to the significant potential for HUMACYL to address a great unmet medical need for patients who are undergoing dialysis,” said Carrie S. Cox, Chairman and Chief Executive Officer (Humacyte).
“We look forward to continuing to work closely with the FDA to facilitate the development and expedited review of HUMACYL with the goal of bringing this novel vascular access product to patients requiring hemodialysis. We applaud the efforts of the FDA in expanding support to advanced therapeutic products through this great new program.”
The current Phase III trial is comparing HUMACYL to an expanded polytetrafluoroethylene (ePTFE) graft in 350 patients with kidney failure who are not candidates for fistula placement. Phase II results were published last year and indicated that HUMACYL may have potential for longer-term use improving the safety of patients with end stage renal disease who require renal replacement therapy and are not candidates for fistula.
RMAT designation means that the FDA will assign additional resources to facilitating the efficient development and expedited review of HUMACYL for vascular access to patients that require life-sustaining hemodialysis. Adapted from the model of other FDA expedited programs such as Breakthrough Therapy, the RMAT designation is a new expedited program for regenerative medicine products.
Learn more about the HUMACYL Phase III clinical trial at ClinicalTrials.gov.