Humacyte, Inc., a medical research, discovery, and development company, focuses on developing and commercializing a proprietary technology based on human tissue-based products for application in regenerative medicine and vascular surgery. It designs acellular extracellular matrices, which are formed in vitro from banked vascular smooth muscle cells and decellularized to eliminate the risk of rejection; and used as tissue-engineered grafts for patients in need of vascular repair or replacement. The company was incorporated in 2004 and is headquartered in Morrisville, North Carolina.
7020 Kit Creek Road
Morrisville, NC 27560
Founded in 2004
Allosource Distributes First Bioengineered Blood Vessels for Humacyte Phase III Clinical Trial
May 23 16
AlloSource announced the distribution of investigational bioengineered blood vessels for Humacyte's Phase III clinical trials. The first shipment of vessels will be used in the upcoming Phase III clinical trial, which will investigate the potential of Humacyte's blood vessels to improve vascular access for hemodialysis patients with end-stage renal disease. The clinical trial will compare the efficacy of Humacyte's vessels to the current standard of care, synthetic blood vessel replacement with Polytetrafluoroethylene (PTFE) grafts. AlloSource and Humacyte entered into a strategic partnership in 2013, with AlloSource serving as the sole manufacturing partner for Humacyte's blood vessels. The investigational bioengineered vessels are produced using donated human vascular cells that are decellularized to remove the donor identity from the newly created vessels. This process results in the production of investigational human vascular grafts with the potential for implantation into any patient at the time of medical need.
Humacyte Commences Phase III Clinical Trial of Human Acellular Vessel
May 13 16
Humacyte announced the commencement of a Phase III study of HUMACYL, its investigational human cellular 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 study of any bioengineered vascular tissue to date. Among the first sites expected to enroll patients are Brigham & Women's Hospital in Boston, Mass., 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. 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, Inc. Appoints Jeffrey H. Lawson as Chief Medical Officer
Oct 5 15
Humacyte, Inc. announced that it has appointed American Board of Surgery certified surgeon Jeffrey H. Lawson, M.D., Ph.D., as Chief Medical Officer. Dr. Lawson, a clinical advisor to Humacyte over the past 10 years, will oversee the medical and clinical development of the company's products. Dr. Lawson recently served in various leadership roles at Duke University Medical Center (Durham, N.C.), including Professor of Surgery and Pathology, Vice Chair for Research in Surgery and Director of Clinical Trials for the Department of Surgery. Dr. Lawson will be based in Humacyte’s headquarters location at Research Triangle Park, North Carolina, reporting directly to Ms. Cox.