Humacyte said yesterday it launched a U.S. Phase II trial of its Humacyl investigational human acellular vessel exploring the systems’ use for vascular replacement or reconstruction in patients with life or limb-threatening vascular trauma.
The Research Triangle Park, N.C.-based company said it hopes to enroll 40 adult patients at six U.S. sites for the trial, with patient monitoring extending out to 24 months.
“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. Thomas Scalea of the University of Maryland’s R Adams Cowley Shock Trauma Center said in a prepared release.
The first patient in the trial was enrolled last month at Newark, N.J.’s Rutgers University Hospital, Humacyte said. The company is hopeful that it will have topline patient data from the study by late 2020.
“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,” Dr. Michael Curi of Rutgers University said in a press release.
Humacyte said that its Humacyl vessels are currently being studied in a Phase III pivotal trial in the US and Europe exploring their use as a conduit for hemodialysis in patients with end-stage renal disease. The company said it plans to seek regulatory clearances in both regions upon completion.
“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,” prez & CEO Dr. Jeffrey Lawson said in a prepared statement.
In June, Fresenius Medical Care (NYSE:FMS; ETR:FRE) said that it inked a $150 million strategic partnership deal with Humacyte through which Fresenius will gain exclusive rights to commercialize Humacyte’s Humacyl bioengineered blood vessel technology.