Humacyte publishes preclinical study on HAV to treat Tetralogy of Fallot

Humacyte announced publication of a preclinical study showing the potential for its investigational small-diameter Human Acellular Vessel to treat Tetralogy of Fallot, a heart condition that affects one in every 2,000 babies born each year. The publication in the open-access Journal of Thoracic and Cardiovascular Surgery, entitled “Evaluation of tissue-engineered human acellular vessels as a Blalock-Taussig-Thomas shunt in a juvenile primate model,” describes a preclinical study in which researchers from Humacyte and Nationwide Children’s Hospital implanted 3.5mm diameter HAVs into a juvenile large-animal model of pediatric heart disease. The 3.5mm HAV was implanted between the subclavian and pulmonary arteries, to mimic a commonly-performed surgical procedure used to treat babies born with Tetralogy of Fallot, one of the most common pediatric heart conditions. The study assessed the HAV’s patency, structure, and blood flow from one week to six months after the implant. The 3.5mm HAVs remained patent for up to six months, and evidence of HAV repopulation by host cells was observed, similar to what has been observed in human patients implanted with 6.0mm HAVs. This study also demonstrates the successful extension of Humacyte’s manufacturing platform, from the production of 6.0mm vessels to 3.5mm vessels. Humacyte’s 3.5mm HAV is also currently being tested in large-animal models of adult coronary artery bypass grafting to assess the potential of the Humacyte platform to make vessels treating a range of heart conditions, spanning from pediatric to adult. The 6.0mm HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease. The 3.5mm HAV is being studied in preclinical models in several different potential indications. The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.