72
Participants
Start Date
September 1, 2018
Primary Completion Date
September 1, 2027
Study Completion Date
September 1, 2027
Human Acellular Vessel (HAV)
The investigational medicinal product (IMP) - the Human Acellular Vessel (HAV) is a sterile acellular tubular graft composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin which can be used for arterial bypass or reconstruction in patients with life or limb threatening vascular trauma. The vessel is 6 mm in diameter and approximately 42 cm in length. The product is supplied on a silicone mandrel immersed in sterile phosphate buffered saline in a sealed and labeled plastic container. The Humacyte HAV is implanted using standard vascular surgical techniques similar to placement of predicate peripheral vascular prostheses.
Penn Presbyterian Medical Center, Philadelphia
Temple University Hospital, Philadelphia
R Adams Cowley Baltimore Shock Trauma, Baltimore
Johns Hopkins Bayview Medical Center, Baltimore
Johns Hopkins Hospital, Baltimore
University of Virginia Health System, Charlottesville
Atrium Health Wake Forest Baptist Medical Center, Winston-Salem
Wake Forest School of Medicine, Winston-Salem
Duke University Hospital, Durham
Grady Memorial Hospital, Atlanta
UF Health Jacksonville, Jacksonville
Jackson South Medical Center, Miami
Ryder Trauma Center, Miami
Tampa General Hospital, Tampa
Vanderbilt University Medical Center, Nashville
Mayo Clinic, Rochester
Saint Louis University (SLU), St Louis
The University of Texas - Dell Medical School, Austin
Ernest E Moore Shock Trauma Center at Denver Health, Denver
Keck Hospital of University of Southern California (USC), Los Angeles
Cedars-Sinai Medical Cener, Los Angeles
Jacob Medical Center at UC San Diego, La Jolla
University of California San Diego (UCSD) Medical Center, San Diego
UCI Medical Center, Orange
University California, Davis, Sacramento
Oregon Health & Science University, Portland
Rambam Health Care Campus - Vascular Surgery Department, Haifa
The Chaim Sheba Medical Center - Vascular Surgery Department, Ramat Gan
Soroka Medical Center - Vascular Surgery Department, Beersheba
Shaare Zedek Medical Center, Jerusalem
Cooper University Hospital, Camden
Rutgers New Jersey Medical School, Newark
Lead Sponsor
Collaborators (1)
Atlantic Research Group
OTHER
U.S. Army Medical Research and Development Command
FED
Humacyte, Inc.
INDUSTRY