FORT DETRICK, Md. — To hear him tell it, Dr. Oleksandr Sokolov has been working round-the-clock for almost a year now. A vascular surgeon by trade, Sokolov is one of a small team of medical professionals currently performing a variety of life-saving surgical procedures to people injured in the ongoing conflict in Ukraine, under what can rightly be considered some of the most difficult conditions imaginable. In his words, it’s not so much the stress of the job in particular that grinds you down, but rather the stress of the situation in general.
“Rocket attacks occur mostly at night … [and so] a big problem is broken sleep,” says Sokolov, describing the conditions where he is located. “Living like this and working at high intensity is harder than it seems.”
It’s not particularly healthy, of course, to keep such hours, but from Sokolov’s perspective there is no other choice. Born, raised and professionally trained in Ukraine, he additionally serves as a lecturer at Dnipro State Medical University’s Department of Surgery.
By Sokolov’s estimation, more than 80% of people sustaining vascular injuries since the war began in February have died almost immediately; the cause of death ranging from lack of access to care to the severity of the injuries themselves. Many of those lucky enough to get treatment, however, have benefitted greatly from the use of a cutting-edge technology developed in the U.S. and supported by the U.S. Army Medical Research and Development Command and its partners.
This technology — a bioengineered blood vessel called the human acellular vessel, or HAV — shows not only the command’s reach but its impact as well, confirming its status as a key player on the global medical stage. For surgeons like Sokolov, the combination has been a literal lifesaver.
“We are very grateful for the invaluable support during this difficult time,” he says, communicating via email due to time zone differences and scheduling issues. “The HAV implantations performed for patients with blast trauma helped save their lives and limbs.”
While the HAV’s impact in Ukraine is notable in itself, the story of the HAV’s maturation process from simple idea to actual, physical product is perhaps even more interesting — and perhaps a symbol of how USAMRDC and its partners can couple with corporate entities to work both seamlessly and effectively.
Developed by Humacyte, a North Carolina-based biotechnology company, the HAV was created specifically for use in the repair and reconstruction of various types of vascular injuries. During the early days of the company, which launched in 2004, Humacyte secured funding through the federal government’s Small Business Innovation Research and Small Business Technology Transfer programs, which are in turn highly competitive programs designed to encourage domestic small business engagement with the federal government in order to help cultivate potential commercialization prospects.
Back in 2012, after the company began initial clinical trials in end-stage renal disease patients requiring hemodialysis access, officials with the U.S. Department of Defense encouraged Humacyte to take its then-nascent HAV technology to the Medical Technology Enterprise Consortium. MTEC is an organization whose mission is to assist USAMRDC in finding and then transitioning medical solutions to industry that protect, treat, and optimize Warfighter health in general. That’s when things really started to take off.
“Early funding from MTEC was instrumental in moving our manufacturing platform development forward,” says Dr. Juliana Blum, executive vice president of corporate development for Humacyte and one of the founders of the company. “It allowed us to achieve building the first commercial-scale tissue engineering system.”
In short, MTEC’s specific purpose is to foster collaborations that move key projects forward. As a 501(c)(3) nonprofit entity, MTEC consists of more than 540 industry and academic organizations committed to developing medical tools and technologies that better manage, prevent, diagnose and treat a wide range of injuries.
It was this unique consortium-based approach that helped propel the HAV forward so quickly as MTEC, in the role of facilitator and key point-of-contact, helped the DOD and Humacyte determine a pathway that met the military’s needs. In 2017, Humacyte secured more than $6.8 million in funding from USAMRDC through MTEC.
“MTEC funding has provided Humacyte an opportunity to partner with the military to navigate the uncharted regulatory pathway of innovative products to treat vascular injuries,” says Lauren Palestrini, director of research programs at MTEC. “We’ve developed strong ties throughout USAMRDC since our inception in 2015, and as a result our teaming and collaboration capabilities across the small business community specifically helps our military sponsors to access a dynamic, innovative ecosystem that is uniquely suited to encourage small startup companies developing technologies in the military medicine space.”
Ultimately, after receiving both Phase 1 and Phase 2 funding via the SBIR-SITTR program, the HAV project was transferred to MTEC for additional prototype funding, a process that included funding for the clinical evaluation of HAV technology in patients experiencing blood vessel damage caused by blunt trauma, penetrating injuries or other catastrophic events.
“Securing those early funds through MTEC supported the development and qualification of our novel, commercial scale manufacturing system,” says Blum, taking stock of the dramatic rise of the fortunes of both the company and the HAV over the past several years.
As for how the HAV became the focal point of a medical aid shipment to Ukraine, that’s almost a separate story in itself.
As Blum explains, Ukrainian surgeons like Dr. Sokolov requested the HAV in March, just a few weeks after the conflict began. What initially began as one or two requests quickly grew to more than a dozen, leading Humacyte to seek collaborative international support to help process the demand.
Since the HAV is currently tagged as an investigational product by the U.S. Food and Drug Administration — meaning it is not yet fully approved by the organization — the team at Humacyte worked alongside the FDA’s Office of International Programs, Ukraine’s Ministry of Health, and a myriad of supply chain experts and medical supply depots to send a shipment of HAVs to Ukraine in the early summer for distribution to a handful of hospitals. In turn, those HAVs have been used to treat patients with shrapnel wounds, gunshots and mine blast injuries, among others. For purposes of data collection, surgeons routinely update Humacyte on their patients’ progress and outcomes.
For Blum, watching the process take shape has been, in her own words, “a powerful experience.” For Palestrini, the impact is exactly what MTEC was created for in the first place.
“Absolutely a success story,” says Palestrini, regarding the HAV. “It is exciting to see where they started out to now being used in humanitarian efforts in the Ukraine. We are excited to have been instrumental in advancing the maturity of the HAV to make this use case possible.”
For his part, Sokolov continues to persevere in the most difficult of conditions, filling his days by performing a variety of reconstructive operations on the arteries and veins of those injured in the war.
He describes the admittance process at his location — which he does not reveal due to safety and security reasons — as “controlled chaos,” noting that circumstances often require accelerated examination procedures and direct medical care. He notes, however, that the HAV has saved significant operating time due to the absence of the need for surgeons to remove a human vein for making a bypass.
In all, it is slow, difficult, valuable work — work that USAMRDC and MTEC help enable by operating in concert with various industry partners in a chain that ultimately stretches more than halfway around the world. The impact — as relayed by Sokolov — is the most important part.
“We are currently doing our best in a difficult situation, preserving humanity and valuing every human life,” he says, stating that he doesn’t plan on leaving his location any time soon. “I feel that I am needed right here, today.”