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Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma
Sponsor: Humacyte, Inc.
Summary
This study evaluates the use of the Human Acellular Vessel (HAV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be a torso cohort and a limb cohort. All subjects will be implanted with a HAV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.
Official title: A Phase 2/3 Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients With Life or Limb-threatening Vascular Trauma
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2018-09-01
Completion Date
2027-09-01
Last Updated
2023-11-02
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (32)
Jacob Medical Center at UC San Diego
La Jolla, California, United States
Keck Hospital of University of Southern California (USC)
Los Angeles, California, United States
Cedars-Sinai Medical Cener
Los Angeles, California, United States
UCI Medical Center
Orange, California, United States
University California, Davis
Sacramento, California, United States
University of California San Diego (UCSD) Medical Center
San Diego, California, United States
Ernest E Moore Shock Trauma Center at Denver Health
Denver, Colorado, United States
UF Health Jacksonville
Jacksonville, Florida, United States
Jackson South Medical Center
Miami, Florida, United States
Ryder Trauma Center
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
R Adams Cowley Baltimore Shock Trauma
Baltimore, Maryland, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Louis University (SLU)
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Duke University Hospital
Durham, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The University of Texas - Dell Medical School
Austin, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Soroka Medical Center - Vascular Surgery Department
Beersheba, Israel
Rambam Health Care Campus - Vascular Surgery Department
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
The Chaim Sheba Medical Center - Vascular Surgery Department
Ramat Gan, Israel