RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Humacyte, an innovator in biotechnology and regenerative medicine, announced the initiation of a U.S. Phase II vascular trauma clinical trial of HUMACYL®, its investigational human acellular vessel (HAV), for vascular replacement or reconstruction in patients with life- or limb-threatening vascular trauma.
The Phase II vascular trauma study was initiated last month and will be conducted at six sites in the U.S. The trial will evaluate approximately 40 adult patients with life- or limb-threatening vascular trauma that require surgical repair. Enrollment in the trial has begun and will continue for 24 months. The initial patients were enrolled at Rutgers University Hospital in Newark, New Jersey and R. Adams Cowley Shock Trauma Center in Baltimore, Maryland; other sites expected to enroll patients include Johns Hopkins University in Baltimore, Maryland; Marcus Trauma Center in Atlanta, Georgia; Ryder Trauma Center in Miami, Florida; and Rocky Mountain Regional Trauma Center in Denver, Colorado.
“As pioneers in regenerative medicine and vascular research, we believe we have a unique and compelling solution to reduce the significant loss of life related to traumatic vascular injuries of civilian victims of violent crimes, automobile accidents, industrial incidents and more,” said Jeffrey Lawson, MD, PhD, President and Chief Executive Officer of Humacyte. “HUMACYL has the potential to be a first-in-class therapy for long-term blood vessel restoration or reconstruction of traumatic vascular injuries, and the advancement of our Phase II study represents a significant milestone to investigate the potential of HUMACYL in clinical vascular trauma.”
“A tremendous medical need exists for patients with traumatic injuries who are in need of vascular reconstruction both in the civilian and military populations,” said Michael Curi, MD, MPA, Chief, Division of Vascular Surgery with Rutgers University. “Advancements in tissue engineering, such as Humacyte’s bioengineered vessel, have the potential to be a game-changer for both patients and the brave members of our armed forces who may experience this critical need. Rutgers University is thrilled to participate in this significant investigational Phase II vascular trauma clinical study as part of our ongoing commitment to improve the lives of every patient, every day.”
“As a world leader in trauma research, we are constantly exploring new and innovative approaches to treating life threatening injuries,” said Thomas Scalea, MD, Francis X. Kelly Distinguished Professor of Trauma, University of Maryland School of Medicine and Physician-in-Chief, R Adams Cowley Shock Trauma Center, University of Maryland. “We look forward to evaluating this bioengineered blood vessel in the treatment of appropriate patients requiring vascular surgical repair.”
The first patient in this Phase II vascular trauma study was enrolled in the U.S. in September 2018, and has now surpassed 30 days in the study. Humacyte anticipates topline patient data from this investigative study to be available in late 2020.
Vascular trauma remains a major cause of morbidity and mortality. In October 2017, Humacyte announced that the company received a Broad Agency Announcement (BAA) contract award from the United States Department of Defense (DoD) to help support the addition of clinical sites for this investigative trial.
Humacyte’s HUMACYL is also currently in a Phase III pivotal trial in the U.S. and Europe as a conduit for hemodialysis in patients with end-stage renal disease. The company plans to seek regulatory approval in both regions upon completion of the trial. The company is also conducting a U.S. Phase II clinical trial of the HAV as a bypass graft in patients with peripheral arterial disease (PAD).
This material is based upon work supported by the U.S. Army under Contract No. W81XWH-17-C-0200. Any opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the U.S. Army.
Humacyte, Inc., a privately held company founded by Dr. Laura E. Niklason, M.D., Ph.D., in 2004, is a medical research, discovery and development company with clinical and pre-clinical stage investigational products. Humacyte is primarily focused on developing and commercializing a proprietary novel technology based on human tissue-based products for key applications in regenerative medicine and vascular surgery. The company uses its innovative, proprietary platform technology to engineer human, extracellular matrix-based tissues that can be shaped into tubes, sheets, or particulate conformations, with properties similar to native tissues. These are being developed for potential use in many specific applications, with the goal to significantly improve treatment outcomes for many patients, including those with vascular disease and those requiring hemodialysis. The company’s proprietary technologies are designed to create off-the-shelf products that, once approved, can be utilized in any patient. The company web site is www.humacyte.com.
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