There are not so much info in the media about this story however I suppose it is remarkable. And while it is not completely my topic, I suppose it is worth sharing, because it obviously demonstrates how innovative products of biotech can help Ukraine today.
Humacyte is a clinical-stage biotechnology platform company with headquarters in Durham, N.C. developing universally implantable bioengineered human tissue at commercial scale. The first and very promising developments of the company is Human Acellular Vessels (HAV). HAVs are made by seeding vascular cells from a qualified cell bank onto a biocompatible, biodegradable polymer mesh in a bioreactor bag. Over weeks, the cells grow and create new tissue, forming a tube-shaped vessel structure while the polymer mesh degrades. The resulting bioengineered vessel is then decellularized to create the HAV: an extracellular matrix that retains the biomechanical properties of the vessel but is cleansed of cellular components that could induce an immune response.
These experimental, engineered vessels are being developed for vascular repair, reconstruction, and replacement and the idea is to produce them in commercial scale and make them available for the surgeons off-the-shelf.
These vessels of different shapes and sizes engineered and grown in the laboratory can really revolutionize the regenerative medicine. These are not implants, not “a piece of plastic”, this is something really new.
However the product is still on investigational stage and has not been approved for sale by the FDA or any international regulatory agency. Currently the HAV is being evaluated in two Phase 3 trials in arteriovenous access (e.g. for hemodialysis) and a Phase 2/3 clinical trial in vascular trauma for use a vascular replacement to restore blood flow to a limb, when saphenous veins or synthetic grafts are not a good option. Also, the HAV has received priority designation the treatment of vascular trauma by the U.S. Secretary of Defense. It is supported by robust clinical efficacy and safety data in 430+ patients and is the first product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from FDA. It has also received FDA Fast Track designation for the creation of vascular access for performing hemodialysis.
Once Russia started the full-scale invasion in Ukraine, people in Humacyte quickly realized that their products can be useful for the Ukrainians with vascular injury. In May the company announced that together with the Office of International Programs within the FDA as well as the Ukraine Ministry of Health they coordinate export and import of the investigational HAV for humanitarian use. Six hospitals in Ukraine, including in Kyiv, Kharkiv and other cities were selected for the initial shipment.
“This initiative began as a request from one Ukrainian surgeon who was familiar with the HAV. Quickly, requests grew from other surgeons and sites around Ukraine. We continue to receive requests from local surgeons for the product candidate and plan to coordinate shipments to additional hospital sites as soon as possible,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “Humacyte is proud to contribute to the ongoing Ukraine medical relief and to support the patients and the brave medical providers on the ground during this humanitarian crisis. I’m immensely grateful to the Humacyte team for their tireless work seeing this through, as well as clinicians in Poland and the U.S. who have volunteered to assist in training Ukrainian physicians in the use of the HAV.”
Laura Niklason, CEO of Humacyte
And in the middle of August Laura Niklason has reported about first successful application of HAVs in Ukraine.
“We are thrilled that the HAVs implanted in several Ukrainian patients are reported to be functioning and infection-free, providing further real-world evidence of the potential of HAV treatment for trauma.”
It is really heartwarming to read the stories of such support from innovative biotech and pharmaceutical companies who provide humanitarian help, donations and even their innovative products to support Ukraine. Our country becomes not only the territory of the war where different modern weapons are trialed to defend the country in the best way but also the territory where innovative technologies can be applied to save people lives.
We thank the team of Humacyte and all the companies who support Ukraine these days.
Also want to remind that you can donate to Enamine Charity Fund and it will be also your support for Ukraine. We help to acquire non-lethal military aid to enhance the defense of Ukraine, provide medical supplies to the hospitals and provide sponsorship for science and education in Ukraine.