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Humacyte Announces Publication of Positive Long-Term Follow-Up Data from Phase 2 Trial of HAV™ for Hemodialysis
-- Five-year data demonstrate the potential of the Human Acellular VesselTM (HAV) to be a durable and safe option for vascular access for routine, long-term
About this update from Humacyte, Inc.
[{"type":"text","content":"-- Five-year data demonstrate the potential of the Human Acellular VesselTM (HAV) to be a durable and safe option for vascular access for routine, long-term hemodialysis -- -- Results published in EJVES Vascular Forum -- DURHAM, N.C., Feb. 28, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that five-year data from a Phase 2 clinical trial of patients receiving the investigational Human Acellular Vessel (HAV) for arteriovenous (AV) access in hemodialysis have been published in the European Journal of Vascular and Endovascular Surgery companion journal EJVES Vascular Forum. The manuscript, entitled, “Five-year outcome in patients with end-stage renal disease who received the bioengineered human acellular vessel for dialysis access,” reports the durable long-term use and ongoing clinical function of the HAV in patients with end-stage renal disease who are undergoing hemodialysis. In the Phase 2 long-term follow-up data, the HAV was observed to provide routine and functional hemodialysis access for patients with end-stage renal disease who require dialysis three times a week. At month 60, patency allowing for reliable dialysis access cannulation was estimated at 58.2% of evaluable patients (i.e., those who completed the original 24-month study with patent HAVs and consented to participate in the long-term follow up) (95% confidence interval: 39.2 to 73.1%), after censoring for deaths and withdrawals. While there was no comparator in this Phase 2 trial, historical reports of arteriovenous fistula (AVF), currently the most prevalent method of providing hemodialysis access, indicate an approximately 30% functional patency of evaluable patients at five years1. In addition, no infections of the HAV were reported during the five-year follow-up period, with the HAV being well tolerated and non-immunogenic. “Patients with end-stage renal disease require chronic vascular access for hemodialysis, and those who are not candidates for fistulas must rely on synthetic arteriovenous grafts, which have a higher rate of complications including an increased risk of infection,” said Prof. Tomasz Jakimowicz, M.D., Ph.D., of the Medical University of Warsaw, Poland, and principal investigator of the ...