Ukrainian Surgeons Present Experience With Humacyte’s Human Acellular Vessel to Treat Wartime Vascular Trauma

September 23, 2022—Humacyte, Inc. announced that surgeons from Ukraine presented findings on the use of the company’s human acellular vessel (HAV) for the treatment of vascular trauma in the ongoing Russian-Ukrainian war. The company’s investigational HAV is designed to offer off-the-shelf availability and resistance to infection and address limitations in vascular tissue repair and replacement, noted the company. It can be manufactured at a commercial scale, it eliminates the need for harvesting a vessel from a patient, and clinical evidence suggests that it is nonimmunogenic, infection resistant, and can become durable living tissue.

At the 36th European Society for Vascular Surgery (ESVS) annual meeting held September 20-23 in Rome, Italy, Vasyl Shaprynskyi, MD, presented an in-person lecture entitled, “The First Experience of Using the Human Acellular Vessels in Ukraine for the Treatment of Patients with Vascular Trauma.”

Oleksandr Sokolov, MD, speaking from Ukraine, delivered a virtual presentation at ESVS entitled, “Vascular Trauma Due to Blast Injury. Experience of Dnipro in Russian-Ukrainian War 2022.”

According to the company, Drs. Shaprynskyi and Sokolov reported that surgeons in Ukraine have used the HAV to treat patients with a multitude of wartime injuries.

Dr. Sokolov provided a clinical update on a patient with a blast injury to the shoulder who received repair using the HAV. The patient is now beyond 3-month follow-up without complication. Another patient who experienced a blast injury to the lower leg underwent successful HAV implantation and is now at 1-month postsurgery without complications.

Dr. Shaprynskyi reported on a patient with a gunshot wound to the right thigh that was initially treated with a synthetic graft; ultimately, the graft failed because of infection, putting the patient at risk of limb loss. The HAV was used to replace the infected graft, and 3 months later, the HAV is supplying blood flow to the limb and is infection free.

According to the company, Drs. Shaprynskyi and Sokolov have been instrumental in establishing their hospitals as medical strongholds during the Russian-Ukrainian war and reported that blast trauma, causing massive tissue damage and infected wounds, accounts for approximately 82% of incoming vascular trauma cases to their medical centers. Trauma to the extremities makes up the majority of injuries—primarily, vascular injuries to the lower extremities and shoulders.

As quoted in the company’s press release, Dr. Shaprynskyi stated, “Access to the HAV, a biologic conduit, has improved our ability to perform vascular reconstructions by eliminating the need to harvest a venous conduit and saving time required to look for useable vein, assisting greatly in limb salvation.”

He continued, “While we continue to face this crisis in our country, partnerships with groups like Humacyte allow us to overcome many limitations in wartime medical care that we previously experienced, such as lack of readily available conduits that are resistant to infection, particularly important in the contaminated battlefield setting.”

The company advised it has worked with the FDA’s Office of International Programs and the Ukrainian Ministry of Health to provide the HAV as an additional treatment option to those affected with vascular injury in Ukraine.

The ESVS presentations come after the company’s recent announcement of the presentation on the HAV for treatment of vascular trauma by Todd E. Rasmussen, MD, (Colonel [Retired], United States Air Force) at the 44th International Committee of Military Medicine World Congress held in Brussels, Belgium, on September 5-9, 2022. Dr. Rasmussen reported to an audience of NATO and other international surgeons on the incidence of wartime vascular injury and highlighted the clinical progress of the HAV, including updates on his own experiences and those of his colleagues using the vessel to treat patients.

Humacyte is currently evaluating the HAV in a phase 2/3 clinical trial in vascular trauma for use as a vascular replacement to restore blood flow to a limb when saphenous veins or synthetic grafts are not feasible. The HAV has received priority designation for the treatment of vascular trauma by the United States Secretary of Defense.

Also, the HAV is being evaluated in two phase 3 trials in arteriovenous (AV) access. Humacyte’s 6-mm HAV for AV access for performing hemodialysis received the FDA’s Regenerative Medicine Advanced Therapy designation and FDA Fast Track designation.

The HAV is an investigational product and has not been approved for sale by the FDA or any international regulatory agency, noted the company.

Laura Niklason, MD, CEO of Humacyte, commented in the company’s press release, “As we progress in our humanitarian efforts with the HAV, being able to witness these firsthand patient cases from surgeons in Ukraine is a powerful experience. We set out to develop engineered replacement vessels that are durable, infection resistant, and off the shelf to address long-standing limitations in vessel repair, both for civilians and for military personnel. Given our existing designation as a priority product from the United States Department of Defense, it is gratifying to see that the HAV is helping patients suffering from wartime injuries in Ukraine right now.”