Humacyte, Inc. develops products for vascular disease and replacement of anatomical conduits. It offers human tissue-based products for regenerative medicine and vascular surgery applications; off-the-shelf extracellular matrix tissue products, which are formed in vitro from banked vascular smooth muscle cells and then decellularized to eliminate the risk of rejection; and vascular grafts. Humacyte, Inc. has a strategic manufacturing partnership with AlloSource. The company was incorporated in 2004 and is headquartered in Morrisville, North Carolina.
7020 Kit Creek Road
Morrisville, NC 27560
Founded in 2004
Humacyte, Inc. Presents Interim First-In-Human Data for Investigational Bioengineered Blood Vessel at the American Heart Association Scientific Sessions 2013
Nov 20 13
Humacyte, Inc. announced the presentation of interim, first-in-human data from an ongoing, multi-center study in Poland, evaluating the company's investigational bioengineered blood vessel in hemodialysis patients with End-Stage Renal Disease (ESRD). The data were presented by Dr. Jeffrey H. Lawson, M.D., Ph.D., at the American Heart Association Scientific Sessions 2013 in Dallas, Texas (abstract). Dr. Lawson is Professor of Surgery and Pathology with tenure at Duke University Medical Center (Durham, North Carolina, USA), and Director of the Vascular Research Laboratory and Director of Clinical Trials for the Department of Surgery. He is also Clinical Consultant to Humacyte. This is the first time surgical data from patients have been reported for the company's investigational bioengineered vessel; the interim data come from a cohort of 28 study participants out of a total of 30 that will ultimately be enrolled in the three-site study in Poland. The first patients were implanted with the investigational vessels in December, 2012, and the vessels were first used for hemodialysis in February, 2013. The primary endpoints of the study in Poland are safety, tolerability, and patency to be examined at each visit within the first six months after graft implantation. Patients will be followed for an additional six months. The interim patient data suggest that the Humacyte investigational bioengineered vessel may potentially be associated with low rates of vessel clotting, low infection rates, and low rates of surgical interventions. Low rates of clotting and intervention are consistent with preclinical data from animal testing that indicated little intimal hyperplasia. Preclinical data also indicated that, in animals, investigational vessels were remodeled to become living and more similar to native tissue. To date in the Polish study, the investigational vessel has remained open to blood flow (patent), with no indication of an immune response in recipients, no aneurysms (abnormal widening or ballooning of part of an artery due to weakness in the blood vessel wall), and flow rates and durability suitable for dialysis. Longer follow-up and additional clinical studies will be required to confirm these preliminary observations.
Allosource and Humacyte Inc. Become Strategic Manufacturing Partners to Create Investigational Bioengineered Blood Vessels from Tissue Donor Cells
Oct 10 13
AlloSource and Humacyte Inc. announced that they have entered into a long-term strategic manufacturing partnership. According to the agreement, AlloSource will become the sole manufacturing partner to create Humacyte's investigational bioengineered blood vessels being developed for hemodialysis applications. Humacyte, a developer of novel human tissue-based products for potential applications in regenerative medicine and vascular surgery, uses innovative technology to create the first investigational biological replacement vessels that are being developed to be stored "off-the-shelf" for future use. Subject to ongoing research and development and future regulatory approval, Humacyte's investigational bioengineered vessels could be used to create a vascular graft option available for patients on demand. These investigational bioengineered vessels are produced using donated human vascular cells and then 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 to be implanted into any patient at the time of medical need.