Medical research, discovery and development company Humacyte has started a phase II vascular trauma clinical trial of Humacyl in the US.
Humacyl is an investigational human acellular vessel (HAV), which is being evaluated for vascular replacement or reconstruction in patients with life- or limb-threatening vascular trauma.
The study, which will be carried out across six sites in the US, will evaluate nearly 40 adult patients with life- or limb-threatening vascular trauma that needs surgical repair. Enrollment in the trial has startedand will continue for 24 months.
Initially, the patients were enrolled at Rutgers University Hospital in Newark, New Jersey and R. Adams Cowley Shock Trauma Center in Baltimore, Maryland.
Other sites that are 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.
The first patient in the phase II trial was enrolled in September this year and has now surpassed 30 days in the study. Humacyte expects that topline patient data from the investigative study to be available in late 2020.
Humacyte president and CEO Jeffrey Lawson said: “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.
“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.”
Humacyte claims that Vascular trauma is a major cause of morbidity and mortality. In October 2017, the company has received a broad agency announcement contract award from the US Department of Defense to include additional clinical sites for this investigative trial.
Humacyte is also currently undertaking Humacyl phase III pivotal trial in the US and Europe as a conduit for hemodialysis in patients with end-stage renal disease. The company plans to secure regulatory approval in both regions upon completion of the trial.
A US phase II clinical trial of the HAV is being carried out as a bypass graft in patients with peripheral arterial disease (PAD).