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# FDA Gives Humacyte a Regenerative Medicine Designation
- URL: https://www.fdaweb.com/fda-gives-humacyte-a-regenerative-medicine-designation/
- Published: 2017-03-20T12:00:00.000Z
- Updated: 2026-09-14T22:12:29.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5138249

FDA has granted Humacyte a Regenerative Medicine Advanced Therapy (RMAT) designation for the company’s investigational human acellular vessel Humacyl. The designation was created under the 21st Century Cures Act to help speed development of a regenerative medicine therapy (e.g., cell therapy, therapeutic tissue engineering product, human cell and tissue product, or a combination product using such therapies or products).

The RMAT designation makes a product eligible for the same actions as drugs that receive breakthrough therapy designation, including timely advice and interactive communications with FDA. A product designated as an RMAT also may be eligible for other FDA expedited programs, such as Priority Review.

  
The company says Humacyl has the potential to address unmet medical needs for hemodialysis patients by decreasing vascular access complications. Humacyte is currently undertaking [a Phase 3 clinical trial](http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.humacyte.com%2Fpress%2Fhumacyte-commences-phase-iii-clinical-trial-human-acellular-vessel%2F&esheet=51527903&newsitemid=20170320005777&lan=en-US&anchor=a+Phase+III+clinical+trial&index=2&md5=9a33d7914a2187f5b5047ce861b53b51&ref=fdaweb.com) of Humacyl compared to an expanded polytetrafluoroethylene (ePTFE) graft in 350 patients with kidney failure who are not candidates for fistula placement.