Support
for Ukraine
Providing Humanitarian Aid for Vascular Trauma Injuries
in Ukraine Hospitals
Shortly after the Russian invasion of Ukraine in March of 2022,
Humacyte received a letter from Ukrainian surgeons asking for access to
our Human Acellular Vessel™ (HAV™) for use in cases of war trauma in
their hospitals. Having learned of the HAV and its success in our clinical
trials and expanded access case patients, the surgeons thought it would
be beneficial for use in patients they were faced with treating.
The team at Humacyte quickly worked on navigating the waters of multinational health regulatory organizations, including the Office of Internal Programs within the U.S. FDA as well as the Ukraine Ministry of Health, to arrange approval for the investigational HAV to be sent overseas into an active warzone for humanitarian use. While shipping details were being arranged, our clinical and medical departments worked tirelessly to remotely train Ukrainian surgical teams to work with the HAV, with thorough instructions around handling, suturing, and post-operative care. As the surgeons would later learn, the human-like qualities of the bioengineered vessel were so exact that there was little to no learning curve compared to working with native vessel.
The team at Humacyte quickly worked on navigating the waters of multinational health regulatory organizations, including the Office of Internal Programs within the U.S. FDA as well as the Ukraine Ministry of Health, to arrange approval for the investigational HAV to be sent overseas into an active warzone for humanitarian use. While shipping details were being arranged, our clinical and medical departments worked tirelessly to remotely train Ukrainian surgical teams to work with the HAV, with thorough instructions around handling, suturing, and post-operative care. As the surgeons would later learn, the human-like qualities of the bioengineered vessel were so exact that there was little to no learning curve compared to working with native vessel.
After multiple attempts to arrange the challenging transportation of the
vessels overseas, the Humacyte team was finally able to schedule the
shipment, and the cargo container arrived safely in Kyiv, Ukraine just a
month and a half after the original request for the HAVs was received.
By the end of June two HAVs had already been implanted in injured
civilians, and in the months since delivery our Human Acellular Vessels
have been used to treat over a dozen soldiers and civilians injured
because of the war in Ukraine. Post-operative surgical implant data and
thorough follow-up data have been reported by the surgical teams at
their respective clinical sites for each patient treated. The clinical results
have been outstanding and immensely informative as Humacyte moves
towards filing our Biologics License Agreement, or BLA, for our leading
indication in vascular trauma. The Ukrainian patient implant and followup outcomes will accompany the extensive data collected from our
ongoing V005 clinical trial being conducted in the U.S. and Israel as we
move towards commercialization of the product in the vascular trauma
space.
As a company, Humacyte is exceptionally proud to have contributed to the ongoing medical relief efforts in Ukraine over the last year. Supporting the patients
and brave medical providers has been an honor for us as they face the daily struggles of this humanitarian crisis. We are grateful to our entire team here in
Durham, NC, for their incredible work to see this effort through, and express our gratitude to the surgical teams in the U.S. and Poland who have aided in
training the Ukrainian teams to work with the HAV.
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