US FDA fast-track designation for Humacyte's tissue-based hemodialysis product

By Dan Stanton

- Last updated on GMT

Image: iStock/Ca-ssis
Image: iStock/Ca-ssis
Humacyte has received one of the first US FDA regenerative medicine designations for its investigational human acellular vessels (HAVs) candidate Humacyl.

The 21st​ Century Cures Act​, signed into law in December, introduced an expedited Regenerative Advanced Therapy (RAT) designation for personalised medicine makers.

And this week Humacyte Inc announced it has become one of the first companies to receive the designation – since renamed the Regenerative Medicine Advanced Therapy (RMAT) designation – from the US Food and Drug Administration for Humacyl, in Phase III trials for vascular access to patients in need of life-sustaining hemodialysis.

“Receiving the RMAT designation for the creation of vascular access for hemodialysis is a significant achievement for our company,”​ Humacyte CEO Carrie Cox told Biopharma-Reporter. “It underscores the significant medical need for improvements in vascular access for patients with kidney failure requiring life-sustaining hemodialysis.”

Humacyl is the firm’s lead product using investigational human acellular vessels (HAVs) developed at the firm’s site in North Carolina.

And while Humacyl is yet to have received FDA approval, Humacyte has begun construction on a bioprocessing facility in Research Triangle Park to support the product.

“Receiving the RMAT designation is a great step towards that direction. Being one of the first companies to receive the RMAT designation from the FDA further serves as a testament to the significant potential for HUMACYL to address the significant unmet medical needs for patients with end stage renal disease requiring vascular access who are not candidates for a fistula.”

HAV is produced using a platform tissue engineering technology with qualified, banked, human vascular cells that, when cultured on a biodegradable tubular mesh under controlled bioreactor conditions, generates a complex array of extracellular matrix proteins that over time yields an integrated, lifelike blood vessel.

These are then rendered acellular, leaving behind a bio-engineered, humanized vessel suitable for vascular grafting which according to the company overcomes limitations associated with synthetic materials and autologous grafts.

“The HAV can be stored for long periods on site in the hospital, allowing product to be available on demand in the operating room ‘off the shelf,’”​ we were told.

According to the FDA​, a product is eligible for RMAT designation if it is “a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products,”​ intended to “treat, modify, reverse, or cure a serious or life-threatening disease”​with "preliminary clinical evidence [indicating] that the drug has the potential to address unmet medical needs for such disease or condition."

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