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Carondelet Heart and Vascular Institute at St. Mary’s Hospital First-in-State to Implant Human-Tissue Vessel as Part of Hemodialysis Access Clinical Trial

Jan 21, 2018

Study Aims to Improve Dialysis Care for Patients with End-Stage Kidney Disease


October 2017 – Tucson, AZ – Carondelet Heart and Vascular Institute at St. Mary’s Hospital is one of only two sites in Arizona to surgically implant a conduit made of bioengineered blood vessels containing no human living cells in the arm of an end-stage kidney disease patient undergoing dialysis offering a first-in-class trial for patients.

The bioengineered human acellular vessels (or HAV) – designed to be similar to the patient’s own cells – are used instead of plastic or other synthetic material to create a conduit that is less likely to be rejected by the patient’s own body. Implantation of the HAV is being performed as part of a clinical trial for patients with end-stage renal (kidney) disease.

“This is a first in Arizona, and a really first-in-class trial for patients with limited treatment options due to poor veins who rely on hemodialysis to save their lives,” said Scott Berman, MD, FACS, who implanted Arizona’s first HAV at Carondelet Heart and Vascular Institute at St. Mary’s.

“When we use plastic or other materials for the grafts, there is an expected failure rate much greater than when we use the patient’s own tissue,” said Dr. Berman. “Using this bioengineered acellular tissue—designed to be similar to that already in the body—we hope to provide a longer-term solution for patients in need of durable renal replacement therapy.”

For patients with renal disease or failure, hemodialysis, a process that filters blood from the patient through an external machine to remove waste and excess fluid, is the main treatment option. Many patients have an arteriovenous graft, a strong, semi-permanent tube usually made of plastic or other synthetic material, implanted into their arm that allows access for large quantities of blood to be removed from the patient and filtered through the hemodialysis machine.

The HUMANITY® AV Access Trial is a Phase III clinical study investigating an arteriovenous graft made from a bioengineered human acellular vessel (or HAV) instead of plastic or other material. This trial will compare HAV to standard-of-care plastic grafts in end-stage renal disease patients who are not candidates for fistula placement.

According to statistics from the National Institute of Diabetes and Digestive and Kidney Diseases, at the end of 2009, more than 871,000 people were being treated for end-stage renal disease, with about 400,000 of them requiring some form of dialysis.

For more information about HUMANITY® AV Access Trial, or to determine if you may be a candidate, visit: ClinicalTrials.gov, or call 919-313-9633 ext 185.


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