Humacyte is launching a Phase III study of its lab-grown blood vessel Humacyl in 350 patients with end-stage renal disease who are on hemodialysis and don’t qualify for a standard surgical treatment, and Boston’s Brigham & Women’s Hospital plans to take part.
Plans to move ahead to Phase III follow a promising Phase II clinical study of the bioengineered blood vessel in 60 patients. Results from that trial were published in the medical journal, The Lancet.
For the Phase III trial, Humacyte will conduct the Humanity trial at 35 sites in the U.S., Europe and Israel; the North Carolina-based company touts the endeavor as the largest study to date of any bioengineered vascular tissue.
The study is designed to compare Humacyl with expanded polytetrafluoroethylene grafts, the standard of care in patients not suitable for fistula. A fistula is a treatment where an artery and vein are directly connected for end-stage kidney disease patients in order to make dialysis easier.
Humacyte said the Phase II results for Humacyl are promising enough to continue testing the proposed treatment for patients with end-stage renal disease who are on hemodialysis. That 60-patient trial was designed to evaluate Humacyl’s safety and efficacy. Humacyte said only 1 infection was connected to Humacyl, and that the bioengeneered blood vessel also appeared to be durable. Researchers were unable to detect degeneration of the implant over an average of 16 months. The longest patient follow-up is now more than 3 years, company said.
Interestingly, patient cells appeared to blend with Humacyl, according to the company, suggesting that the body adapted to the implant with no adverse autoimmune reactions, according to the company.