Humacyl vascular trauma trial : Humacyte, a regenerative medical technology company, has started a phase 2 clinical trial of its investigational human acellular vessel (HAV) – Humacyl for vascular replacement or reconstruction in patients suffering from life- or limb-threatening vascular trauma.
Humacyl is a bioengineered human acellular vessel which has been designed to significantly improve the conditions of vascular trauma patients. The human acellular vessel from Humacyte was granted the Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) in March 2017.
Humacyl vascular trauma trial
Commenting on the phase 2 Humacyl vascular trauma trial, Jeffrey Lawson – President and CEO of Humacyte, 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.”
Humacyl vascular trauma trial patient enrollment
The phase 2 Humacyl vascular trauma trial, which started in September 2018, is being carried out in six clinical trial sites across the US. The vascular trauma study is being conducted in nearly 40 adult patients with life or limb-threatening vascular trauma that can be rectified by surgery.
Patient enrollment in the phase 2 Humacyl vascular trauma trial has started and will carry on for a period of two years.
The initial enrollment of patients was at Rutgers University Hospital in Newark, New Jersey and R. Adams Cowley Shock Trauma Center in Baltimore, Maryland; and further enrollments will take place at other sites including Johns Hopkins University in Baltimore, Maryland; Marcus Trauma Center in Atlanta, Georgia; Rocky Mountain Regional Trauma Center in Denver, Colorado; and Ryder Trauma Center in Miami, Florida.
Michael Curi – Chief, Division of Vascular Surgery with Rutgers University, commenting on the phase 2 Humacyl vascular trauma trial, said: “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 II vascular trauma clinical study as part of our ongoing commitment to improve the lives of every patient, every day.”
Humacyte is expecting to release topline patient data from the vascular trauma study by 2020.