Pharma Focus Europe

Humacyte Completes Enrollment in Phase 3 Trial of Human Acellular Vessel™ (HAV™) for Hemodialysis Access in End-Stage Renal Disease Patients

Wednesday, April 12, 2023

Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced it has completed enrollment of a Phase 3 trial in hemodialysis access. The “V007 Trial” is designed to assess the efficacy and safety of the Human Acellular Vessel (HAV) in establishing vascular access for hemodialysis patients with end-stage renal disease (ESRD) as compared to autogenous arteriovenous (AV) fistulas.

The Phase 3 trial, labeled V007, is a prospective, multi-center, randomized, comparative study in 240 hemodialysis patients suffering from ESRD in the United States. Enrolled individuals were randomly assigned to either the ​​HAV, or an AV fistula for hemodialysis. Efficacy assessments include useability of the conduit for dialysis at six and 12 months and a comparison of secondary patency, evaluated at 12 months. The rate of dialysis-related infections in both HAV and fistula subjects will also be tracked as a secondary endpoint.

“Completing enrollment in this Phase 3 trial brings us one step closer to our goal of providing vascular access for dialysis patients that is usable more quickly after implant and reduces reliance on catheters, compared to AV fistula procedures,” said Shamik Parikh MD, Chief Medical Officer at Humacyte. “We believe our regenerative medicine technology has the potential to transform the quality of care nephrologists are able to provide to their patients, and address the substantial failure rate and risk of infection associated with the current AV access options for hemodialysis.”

Nearly 786,000 Americans are currently living with ESRD, a disease that develops when chronic kidney disease progresses to a point where either dialysis or a kidney transplant is required for survival. Dialysis treatments require establishing a durable point of access to a patient’s circulatory system, in order to transfer the large volume of blood that must be transported to the dialysis machine and then back into the patient.

However, the current standard of care for establishing vascular access has significant risks and shortcomings. Catheters, which are tunneled underneath the skin, have high rates of bloodstream infection, while autogenous AV fistulas exhibit a high rate of early maturation failure, forcing patients to rely longer on infection-prone catheters. In addition, many patients are not suitable candidates for fistula placement due to small vessel anatomy, advanced age, obesity, or other comorbidities.

Humacyte’s HAV is a universally implantable, durable tissue-engineered vascular conduit that is designed to be highly resistant to infection and, over time, has been observed to combine with a patient’s own cells to create a living blood vessel. Utilized for AV access, the HAV has the potential to be usable for dialysis more rapidly after implant, and result in reduced time on catheters which pose an infection risk for patients, than an AV fistula procedure.

Dr. John Lane, vascular surgeon at VA San Diego and V007 investigator comments, “My experience with the use of the Human Acellular Vessel in our VA population has been very positive thus far. Being involved with the clinical trial has allowed us to provide patients with the latest and greatest in technology, and hopefully gives a window into what will be in the future for hemodialysis access.”

Hear more from Dr. Lane around his impressions of the HAV and its use in the field of hemodialysis access in this short video:

The Phase 3 V007 trial builds on Humacyte’s series of clinical trials designed to support the use of the HAV technology to expand hemodialysis treatment options. The Company’s 6mm HAV for AV access for hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation in 2017 and was awarded an FDA Fast Track designation in 2014.

The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.



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