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The Medical Technology Enterprise Consortium (MTEC) awarded $650,000 to Humacyte, one of the foremost companies in regenerative medicine and biotechnology. The company intends to direct the MTEC funding toward the development and commercialization of its bioengineered Human Acellular Vessel’s (HAV) function as a hemodialysis conduit in End-Stage Renal Disease (ESRD) patients. The HAV has proven itself a prospectively integral piece to Western medical practice already with a collaborative research project among experts from Yale, Duke University and surgeons in Poland and the US.
The study was published in The Lancet in May 2016, and it sparked renewed investigation via randomized controlled trials. Dialysis is often a requisite mode of treatment for patients enduring kidney failure, and it is typically administered via synthetic graft implanted in the arm. These grafts carry an affinity for infection, though, as well as clotting and a myriad of other complications. Some studies focused on alternative grafts have found that they aren’t any better than synthetics, alt-grafts deriving from a donor, animal tissue, or the patient.
Dr. Laura Niklason, Yale’s Nicholas Greene professor of anesthesiology and biomedical engineering, collaborated with a team of researchers to bioengineer novel vessels that effectually facilitate dialysis access for 60 patients spread out at six different laboratories. These units are HAVs, produced by Humacyte, Inc., which Niklason co-founded. In order to make the vessels, the team started by isolating vascular cells from human donors and letting them mature in vitro. They put the cells on a degradable scaffold in the shape of a blood vessel. The tissue matured and was suffused in nutrients; it was concurrently stretched in order to produce the physical properties that real blood vessels gain.
“After that process, which takes eight weeks, the scaffold degrades and what we have left is engineered tissue that we have grown from scratch,” Niklason explained. Duke professor of surgery and pathology, Jeffrey Lawson, also the chief medical officer at Humacyte and Niklason’s long-time partner, said at the time: “The bioengineered blood vessel represents a critical step in tissue engineering because these vessels contain no living cells; Patients have access to off-the-shelf engineered vessels that can be used without any waiting period associated with tailor-made products.”
The bioengineered vessels proved safe as well as functional a year after implantation. “They are safe and maintain their mechanical integrity,” Niklason said. There’s also no indication of rejection either. Now, Humacyte is receiving funding from MTEC, which is a renowned biomedical technology consortium that contracts out to several federal agencies in the US. MTEC relies on its members all over the United States and across the academic community, industry, and the nonprofit sector to supply the US Army Medical Research and Material Command (USAMRMC) with state-of-the-art technologies.
“With backing from a collaborative national consortium, such as MTEC, we hope to further explore the potential of Humacyl for vascular trauma and to test the stability of our vessel under a range of environmental conditions,” says Ted Lithgow, Ph.D., chief operating officer at Humacyte.
“We’ve continued to achieve significant milestones for the company with the recent completion of enrollment of Phase III clinical trials of Humacyl for patients with ESRD, and our ongoing Phase II clinical trials testing the vessel’s prospects in treating patients with peripheral arterial disease. Our HAV has the potential to address both military and civilian needs, and help patients suffering from vascular trauma,” Lithgow explains.
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The Phase III clinical trials, to which Lithgow referred, completed enrollment of 350 evaluable participants. The study is conducted across 40 sites throughout the United States, Israel, and Europe. It aims to analyze the effectiveness and security of the bioengineered blood vessel being used to facilitate hemodialysis for patients with ESRD. The biomedical tech corporation anticipates a year’s worth of post-implantation patient data to be made available by late 2018 due to the study.
After Humacyte analyzes the data from the Phase III clinical trials, the company intends to pursue marketing authorization for Humacyl, the resultant, biotechnological fruit of the trials. The US Food and Drug Administration (FDA) granted Humacyte’s product the designation of Regenerative Medicine Advanced Therapy (RMAT) this year as well, which is expected to fast-track the review process.
“We’ve achieved a very important milestone for our company by completing enrollment of this pivotal trial. The Humanity trial evaluates the potential of our bioengineered human acellular vessels to create a longer-lasting, more durable vascular access compared to expanded polytetrafluoroethylene (ePTFE) for dialysis in patients with ESRD. With the support of our clinical partners, patients, and employees, we’ve accomplished this critical goal in one of the largest prospective clinical studies conducted in the study of hemodialysis access,” says Carrie S. Cox, Humacyte’s chairman and chief executive officer.
“After we collect the next 12 months of data in patients implanted with Humacyl, we plan to submit the application to gain the necessary regulatory approvals to commercialize Humacyl, and bring our innovation to patients who need an alternative approach to vascular access.”