Humacyte Commences Phase 2 Vascular Trauma Trial of Humacyl

October 25, 2018—Humacyte announced the initiation of a United States phase 2 vascular trauma clinical trial of Humacyl, the company's investigational human acellular vessel (HAV), for vascular replacement or reconstruction in patients with life- or limb-threatening vascular trauma.

The trial will be conducted at six sites in the United States and evaluate approximately 40 adult patients with life- or limb-threatening vascular trauma that require surgical repair. Humacyte anticipates topline patient data from this investigative study to be available in late 2020.

Enrollment 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.

According to the company, the Humacyl HAV has the potential to be a therapy for long-term blood vessel restoration or reconstruction of traumatic vascular injury, thereby reducing the significant loss of life related to civilian victims of violent crimes, automobile accidents, and industrial incidents among other incidents.

Michael Curi, MD, commented in the Humacyte's announcement, “A tremendous medical need exists for patients with traumatic injuries who are in need of vascular reconstruction both in the civilian and military populations. 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 2 vascular trauma clinical study as part of our ongoing commitment to improving the lives of every patient, every day.” Dr. Curi is Chief, Division of Vascular Surgery at Rutgers University.

Thomas Scalea, MD, added, “As a world leader in trauma research, we are constantly exploring new and innovative approaches to treating life-threatening injuries. We look forward to evaluating this bioengineered blood vessel in the treatment of appropriate patients requiring vascular surgical repair.” Dr. Scalea is Francis X. Kelly Distinguished Professor of Trauma, University of Maryland School of Medicine and Physician-in-Chief, R. Adams Cowley Shock Trauma Center, at the University of Maryland.

In October 2017, Humacyte announced that the company received a Broad Agency Announcement contract award from the US Department of Defense to help support the addition of clinical sites for this investigative trial.

Humacyte’s Humacyl is also currently in phase 3 pivotal trial in the United States 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. Additionally, the company is conducting a United States phase 2 clinical trial of the Humacyl HAV as a bypass graft in patients with peripheral arterial disease.