Humacyte announces preclinical study results for the use of human acellular vessels in coronary artery bypass grafting

Humacyte announces preclinical study results for the use of human acellular vessels in coronary artery bypass grafting

 A new preclinical study is showing promising results for the potential use of bioengineered blood vessels to bypass a blocked coronary artery, removing the need to extract a blood vessel from another part of the body.

Humacyte, a clinical-stage biotechnology platform company, has created a human acellular vessel (HAV) which is formed by placing donated smooth muscle cells on a scaffold producing a bioengineered blood vessel that is treated at the end of processing to remove the donor cells from the new vessel. Researchers inserted HAVs into a number of primates as part of a coronary artery bypass graft (CABG).  After six months post-operation, the HAVs were examined. All of them were found to have remained open, unobstructed, and had even displayed cell remodeling to match their host’s own DNA.

“Coronary artery bypass grafting is one of the most common surgical procedures in the U.S., but it currently requires surgically harvesting a saphenous vein for grafting,” said Dr. Kypson, a cardiothoracic surgeon at the University of North Carolina Rex Hospital who performed the surgeries. “The quality and availability of the venous conduit is a critically important factor in a successful CABG, and the potential to eliminate vein harvesting with a universally implantable, readily available acellular vessel is exciting.”

Fresenius Medical Care announced a strategic partnership with Humacyte in July of 2018 when it invested $150 million in the biotech company, and recently announced further investments in late 2021. In addition to this latest pre-clinical study, preliminary research on HAVs has demonstrated their potential for use in hemodialysis as well. This product is currently being investigated in a clinical study for use as a vascular access for hemodialysis patients, and they may prove more effective than conventional synthetic grafts and fistulas in reducing infection as well as central venous catheter use.  Additional clinical programs in vascular trauma and peripheral arterial disease (PAD) are investigating the use of the HAV in vascular repair, reconstruction, and replacement applications.

“Fresenius Medical Care is committed to advancing the field of medicine, and we’re excited about our partnership with Humacyte given the possibilities that lie ahead”, said Dr. Frank Maddux, Global Chief Medical Officer for Fresenius Medical Care. “The human acellular vessel is really a ground-breaking innovation in regenerative medicine that may provide new treatment options for heart disease or traumatic injury, while also potentially improving vascular access for patients on hemodialysis.”

To create an HAV, vascular cells are cultured for 8 weeks in a bioreactor system and placed along a scaffold as new tissue is grown. The tissue is then decellularized, a process that maintains the vessel’s biomechanical properties while helping prevent immune-response reactions. Over time in the patient’s body, the HAV can remodel its vascular structure to be more similar to that of its recipient and has been shown to be infection resistant and durable.

For people living with kidney failure, the connection between heart and kidney disease is especially important. Both diseases share the common risk factors of high blood pressure, high cholesterol and diabetes, and the health of the two organs is intricately linked, as many patients with kidney failure ultimately die of heart failure. Humacyte’s technology has the potential to transform both kidney and heart care, with the goal of delivering significant improvements in patient outcomes.

For more information on HAVs, listen to this discussion with Dr. Laura Niklason, co-founder of Humacyte, discussing the potential impact of HAVs for dialysis patients.