Trial Profile

An Assessment of Humacyte's Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison With ePTFE Grafts as Conduits for Hemodialysis (HUMANITY)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 28 Aug 2026

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At a glance

24 Aug 2026 According to a Humacyte, Inc. media release, recent discussions with the FDA confirm the Company's plans and expectations for filing a supplemental Biologic License Application (BLA).Humacyte expects to file the supplemental BLA during November 2026, seeking to add dialysis access as the second approved indication for the ATEV after its December 2024 FDA approval in the vascular trauma indication.
10 Mar 2024 According to an European Clinical Trials Database, this trial has been completed in Portugal and Germany.
01 Feb 2024 Status changed from active, no longer recruiting to completed.

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