Humacyte has announced the initiation of a US phase II vascular trauma clinical trial of Humacyl, its investigational human acellular vessel, 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 USA. The trial will evaluate approximately 40 adult patients with life- or limb-threatening vascular trauma that require surgical repair. Enrolment in the trial has begun and will continue for 24 months. The initial patients were enrolled at Rutgers University Hospital in Newark, USA and R Adams Cowley Shock Trauma Center in Baltimore, USA; other sites expected to enrol patients include Johns Hopkins University in Baltimore, USA; Marcus Trauma Center in Atlanta, USA; Ryder Trauma Center in Miami, USA; and Rocky Mountain Regional Trauma Center in Denver, USA.
“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,” says Jeffrey Lawson, 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,” says Michael Curi, 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,” says Thomas Scalea, 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 USA in September 2018, and has now surpassed 30 days in the study. Humacyte anticipates top line 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 USA and Europe as a conduit for haemodialysis 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 US phase II clinical trial of the human acellular vessel as a bypass graft in patients with peripheral arterial disease.