Ukraine surgeons use tissue made by alumna’s firm
The ring tone rose above the sounds of the Atlantic Ocean waves.
While Juliana Blum ’98 stepped away to answer the phone during a relaxing family beach day in the Outer Banks of North Carolina, the vascular surgeon on the other end of the call was trying frantically to save lives and limbs 5,000 miles away in battlescarred Ukraine.
He knew about some promising clinical trials that Humacyte, a biotech firm co-founded by Ms. Blum, had been conducting just across the border in Poland. The surgeon wondered if the company’s bioengineered tissue could be used to treat wounded Ukrainian soldiers and civilians during the Russian onslaught. Similar requests came from others in the region.
This feature story first appeared in the Winter 2023 issue of The Carthaginian magazine.
The investigational Human Acellular Vessels (HAV) are designed as an “off-the-shelf” surgical alternative to traditional vascular grafts. Early results suggest they could be more durable than a vein taken from another part of the patient’s body and less prone to infection than implanted synthetic grafts.
Starting with vascular cells from a proprietary cell bank, Humacyte researchers grow new tissue in the lab in a matter of weeks. Each HAV comes packaged in a sterile tube about the length of a windshield wiper, and its temperature is carefully controlled during transport.
Before taking that call, Ms. Blum had a different timeline in mind: two years to market. In the snail-paced U.S. medical approval process, that’s just around the corner. To the pleading surgeons, that was an eternity they couldn’t afford.
So the future arrived early.
Long hours were a tiny price for the Humacyte staff to pay, compared to the constant bombardment their collaborators endured in the war zone. A Ukraine-based regulatory specialist tirelessly coordinated with officials in her country by day and their U.S. counterparts at night, translating as needed.
After securing emergency approval for humanitarian use on both ends, the company shipped out the first HAV batch in May. Doctors were trained remotely via Zoom.
“It was humbling in ways that are hard to describe,” says Ms. Blum, the company’s executive vice president for corporate development. “This is why we do what we do.”
Four months later, two of those Ukrainian surgeons shared preliminary findings with peers from across Europe who attended a medical conference in Rome. The news was encouraging.
They described patients who recovered fully thanks to implanted HAV after suffering severe shoulder and leg injuries in explosions. Another person who’d been shot in the thigh avoided amputation.
As of mid-November, at least nine Ukrainian patients who received the innovative treatment were recuperating or fully recovered from traumatic wounds associated with the ongoing confict and invasion of Russian forces.
“While we continue to face this crisis in our country,” explained Dr. Vasil Shaprynskyi, “partnerships with groups like Humacyte allow us to overcome many limitations in wartime medical care that we previously experienced.”
gritty, not abrasive
The HAV can be grown in a matter of weeks, a stark contrast to the ongoing odyssey the product has taken from concept to reality. It’s been 18 years since Ms. Blum (then a postdoctoral researcher) teamed with Duke University colleagues — led by Dr. Laura Niklason, a pioneer in regenerative medicine — to form Humacyte.
Still entrenched in Durham, North Carolina, the company today employs 160 workers. It went public a couple of years ago.
“I’ve learned a tremendous amount about what it means to bring a novel idea to market,” says Ms. Blum.
It took a surplus of confidence to stay on course. When the Carthage alumna returned to campus to accept a Beacon Award in 2014, she could easily pinpoint the source of hers.
“My husband said, ‘You really can’t get lost here, can you?’ And he was right,” recalls Ms. Blum, who serves on the Alumni Council. “You were accountable, and you grew through that accountability.”
Her workplace sets a similar tone. Backstabbers need not apply.
“The culture of Carthage is very much the culture we try to instill at Humacyte: a mix of being driven and committed while also having respect and integrity,” she says. “We look for others who fit, and not everybody does.”
Bitten by the research bug at Carthage, Ms. Blum was a sort of “beta tester” for a program that has since blossomed into the Summer Undergraduate Research Experience. She shelved a plan for medical school, opting instead to develop innovative treatments and therapies.
Of course, no startup allows you to wear just one hat. Especially early on at Humacyte, Ms. Blum bounced from scientist to business developer to communicator.
“It’s been great to show my daughter what women can do in the science and engineering world,” she says.
Volunteering with Women in Bio, a professional organization with an entrepreneurial focus, Ms. Blum tries to map out a smoother route for others following in her footsteps.
Heading into an uncharted corner of the market, the Carthaginian learned as she went. Like how to steer through a regulatory maze.
The founders hoped to go big right away with the company, making vessels for coronary bypasses, and started looking ahead to clinical trials. Reluctant to put heart patients in the hands of the new kids on the biomedical block, peers and advisors — including the Food and Drug Administration — advised the firm to take baby steps first.
Unfazed, the team pivoted to other vascular applications that could be tested in humans without endangering their lives: hemodialysis (a blood-cleansing procedure), peripheral arterial replacements, and traumatic injury repair.
Ms. Blum learned about scale, too. Odd as it sounds to talk about bodily tissue in manufacturing terms, the company had to learn how to ramp up production. Now, Humacyte can grow up to 200 of the vessels per batch in a facility that’s capable of producing about 40,000 annually.
Company leaders expect FDA approval of the product for use in vascular trauma in 2024. Through a variety of approved trials, doctors have already used the HAV in more than 500 patients worldwide.
It’s still on the table as a possible coronary bypass alternative farther down the line. And Ms. Blum sees plenty of other potential applications for the proprietary bioengineering platform — even managing Type 1 diabetes without insulin.
She can only marvel at the courage and dedication of the team’s medical partners in Ukraine, where patients aren’t the only ones whose lives are at stake. Far from the missile strikes, this forward-thinking Carthaginian is just grateful to contribute to the healing process.