International Study of Humacyte’s Investigational Tissue-Engineered Vascular Conduit for Hemodialysis (HUMANITY®) will be the Largest of its Kind to Date
RESEARCH TRIANGLE PARK, N.C. – May 13, 2016 – Humacyte, an innovator in biotechnology and regenerative medicine, announced today the commencement of a Phase III study of HUMACYL®, its investigational human acellular vessel (HAV), as a conduit for hemodialysis in patients with End-Stage Renal Disease (ESRD) requiring renal replacement therapy and who are not candidates for fistula. In the trial, HUMACYL will be compared to expanded polytetrafluoroethylene (ePTFE) grafts, standard of care for patients not suitable for fistula. The HUMANITY trial will be conducted at approximately 35 sites in the U.S., Europe and Israel with 350 evaluable subjects, making it the largest study of any bioengineered vascular tissue to date. Among the first sites expected to enroll patients are Michigan Vascular Center in Flint, Mich., Vascular Associates in Dallas, Texas, The Regional Medical Center in Orangeburg, S.C., Greenwood Leflore Hospital, Greenwood, Miss., Arizona Kidney Disease and Hypertension Center, Phoenix, Ariz., Washington University, St. Louis, Mo. and University of South Florida, Tampa, Fla.
“Over 400,000 people with End-Stage Renal Disease undergo hemodialysis to remove deadly toxins from the blood when their kidneys fail. Methods for establishing vascular access for dialysis are still inadequate, as evidenced by low rates of long-term patency and significant rates of infection among other complications,” said Jeffrey H. Lawson, M.D., Ph.D., Chief Medical Officer of Humacyte. “HUMACYL is the first bioengineered tissue to advance to Phase III clinical studies for investigation in a life-sustaining use. HUMACYL may offer a potential safe and effective alternative for vascular access in hemodialysis treatment and we are excited to begin this pivotal clinical trial.”
In the Phase II clinical studies of HUMACYL, the HAVs were cannulated and used safely for hemodialysis in the clinic, and patients safely underwent interventions to maintain patency. Phase II study data also suggested the vessel may have the potential for long-term functional vascular patency (the ability of blood vessels to remain open and durable over time). In this 60-patient Phase II trial, the rate of interventions was similar to historic rates for synthetic grafts. Preliminary histological evidence suggests repopulation of HUMACYL with the patient’s own cells, with further studies needed to demonstrate the mechanism of repopulation.
The primary objective of this Phase III study will be to compare the secondary patency of the HAV with that of the ePTFE graft when used as a conduit for hemodialysis. The study population includes subjects with ESRD who require hemodialysis and who are not candidates for fistula and thus are targeted for implantation of an arteriovenous (AV) graft for dialysis access. The rate of access-related infections for the HAV compared with that of the ePTFE graft will also be assessed. The study may also provide data that could help determine whether patency of HUMACYL, together with other potential positive, long-term, clinical outcomes with use of the HAV, may result in lower healthcare costs for care of hemodialysis patients. Humacyte believes that the results of this prospective, open-label, randomized, two-arm, comparative study will help support an application for marketing authorization using 12-month active study patient data post-implantation of the vascular access conduit. Patients will be followed up to 76 months inclusive of initiation of enrollment through completion of final data collection.
Humacyte, Inc., a privately held company founded in 2004, is a medical research, discovery and development company with clinical and pre-clinical stage investigational products. Humacyte is primarily focused on developing and commercializing a proprietary novel technology based on human tissue-based products for key applications in regenerative medicine and vascular surgery. The company uses its innovative, proprietary platform technology to engineer human, extracellular matrix-based tissues that can be shaped into tubes, sheets, or particulate conformations, with properties similar to native tissues. These are being developed for potential use in many specific applications, with the goal to significantly improve treatment outcomes for many patients, including those with vascular disease and those requiring hemodialysis. The company’s proprietary technologies are designed to create off-the-shelf products that, once approved, can be utilized in any patient. The company web site is www.humacyte.com.
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