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Study Aims to Improve Access Care for Patients with Kidney Failure
September 12, 2016, Summit, NJ – Overlook Medical Center was the first hospital in New Jersey to place a human acellular vessel in a patient’s arm as part of a first-in-class clinical trial for patients with end-stage renal (kidney) disease.
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 sponsored by Humacyte is 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.
“This is a first in New Jersey, and really first-in-class trial for patients with limited treatment options due to poor veins who rely on hemodialysis to save their lives,” said Clifford M. Sales, MD, MBA, FACS, who implanted the state’s first HAV —in the 50th patient enrolled in the nationwide trial—at Overlook Medical Center on August 25.
“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 Sales. “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.”
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 Atlantic Center for Research, or call 973-759-9000.
About the HUMACYTE™ Human Acellular Vessel (HAV)
The HUMACYTE™ Human Acellular Vessel is an investigational tissue-engineered vascular conduit that is being investigated to overcome the limitations associated with synthetic vascular grafts and autologous vessels. The HAV is a sterile, non-pyrogenic acellular tubular conduit composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin.
About Overlook Medical Center
Overlook Medical Center, based in Summit, NJ, is a recognized leader in neuroscience care and home to some of New Jersey’s top doctors, most compassionate care and most advanced technology and treatments. Atlantic Neuroscience Institute is the region’s leader in neuroscience care, offering a broad range of advanced neurological, neurosurgical and neurodiagnostic services. Overlook Medical Center is home to the Brain Tumor Center of New Jersey and the largest and most experienced CyberKnife program in New Jersey. Overlook is certified as a Level IV Epilepsy Center and one of 10 sites in the United States to be designated a Tourette Syndrome Association Centers of Excellence. Overlook Medical Center is the only hospital in New Jersey recognized as one of “America’s 100 Best Hospitals for Stroke Care™ and Critical Care™” in 2016 and New Jersey’s only recipient to receive Healthgrades’ Distinguished Hospital Excellence Award and Stroke Care Excellence Award. U.S. News & World Report recognizes Overlook Medical Center among the best hospitals in central New Jersey and as a “Best Regional Hospital” for neurology & neurosurgery. Accredited for behavioral health care by The Joint Commission, Overlook Medical Center is also advanced certified by The Joint Commission as an Advanced Comprehensive Stroke Center. The hospital is also Joint Commission-certified in spine surgery, wound care, and primary care medical home (PCMH) for patient-centered, comprehensive and coordinated care. Overlook Medical Center is nationally accredited by the American College of Surgeons-Commission on Cancer and the National Accreditation Program for Breast Centers. Overlook Medical Center is part of Atlantic Health System, one of the largest non-profit health care systems in New Jersey.