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Vascular Trauma - Healing Genes
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Vascular Trauma

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Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma

A Phase 2 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


Phase 2

DESCRIPTION:
Doctors at 5 study centers in CO, FL, GA, MD, NJ are seeking patients with vascular injury who require repair of a vessel contained to the upper or lower extremity, or within the thorax (excluding the heart), abdomen, and retroperitoneum. These patients may be eligible to trial an engineered tissue graft (Humacyte Human Acellular Vessel or HAV) that provides a vascular conduit, created from donor tissue that has all cells removed. The researchers hope this new form of fistula will remain patent (open) and more functional than the traditional vascular fistula. The study requires implantation of the HAV as an interposition vessel or bypass using standard vascular surgical techniques.

Follow up after month 12 will involve the capture of information on assessments performed at routine clinic visits or by telephone follow up with the patient or his/her physician with physical exam and ultrasound at month 24 and month 36.


PATIENT MUST:

  • Up to 18 to 85 years of age
  • Have life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, which requires replacement or reconstruction
  • Life expectancy of at least 1 year

THE STUDY INVOLVES:

  1. Prescreening to confirm eligibility of the patient to participate.
  2. Surgery to implant the tissue graft vascular conduit an interposition vessel or bypass using standard vascular surgical techniques.
  3. Follow up will continue for up to 3 years.

LOCATIONS AND CONTACTS:
The study sites are
Denver Health Medical Center in Denver, CO, Map.
Ryder Trauma Center in Miami, FL, Map.
Grady Memorial Hospital in Atlanta, GA, Map.
R Adam Cowley Shock Trauma Center in Baltimore, MA, Map.
Johns Hopkins Bayview Medical Center in Baltimore, MD, Map.
Rutgers New Jersey Medical School in Newark, NJ, Map.
 
CONTACTS:
Angela Rose, MBA  |  919-313-9633 ext 185  |  [email protected]
 
SPONSOR INFORMATION:
Humacyte, Inc.
Atlantic Research Group
U.S. Army Medical Research and Materiel Command
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT03005418

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