Humacyte, Inc., announced the accomplishment of significant milestones in the clinical development of its innovative bioengineered blood vessel technology – the first off-the-shelf, human-derived, artificial blood vessels.
The company received U.S. Food and Drug Administration (FDA) approval for an Investigational New Drug (IND) application to conduct a multi-center U.S. clinical trial to assess safety and efficacy of its innovative bioengineered blood vessel to provide vascular access for dialysis in End-Stage Renal Disease (ESRD) patients.
A multi-center, first-in-human pilot study is under way in Poland to evaluate the safety and efficacy of bioengineered vessels for dialysis access. Earlier this month, an Independent Safety Review Board completed its planned review of three-month safety data for the bioengineered blood vessels and concluded that there were no safety issues and that enrollment of additional patients should continue.
“Humacyte’s bioengineered vessel may be a superior surgical alternative to synthetic materials currently used for kidney dialysis,” said Laura E. Niklason, M.D., Ph.D., professor and vice chair of Anesthesia, professor of Biomedical Engineering, Yale University, and founder, Humacyte. “This technology is a key step for patients with end-stage renal disease and can potentially avoid surgical interventions and hospitalizations for these individuals. Further, demonstrating safety and efficacy in patients with ESRD sets the stage for follow-on development of our technology in other vascular procedures, such as replacement or bypass of diseased vessels, of vessels damaged by trauma, or for other vascular procedures.”
The first bioengineered blood vessel is intended for use in patients with chronic kidney disease, a major global health problem that affects 26 million Americans.[1] Patients that progress to end-stage renal disease require renal replacement therapy (hemodialysis or kidney transplant), and today there are more than 350,000 patients who currently require hemodialysis in the U.S.[2] Synthetic vascular grafts in these patients are prone to wall thickening that leads to graft clotting. As a result, patients are subjected to frequent hospitalization and re-operation.
“We are delighted to have met these critical milestones with the first off-the-shelf bioengineered blood vessels made from human collagen,” said Carrie S. Cox, chairman and chief executive officer, Humacyte. “Receiving approval to proceed with U.S. clinical studies is another key step towards bringing this unique technology to surgeons and patients.”
First U.S. Clinical Trial Approved
Under the FDA-approved IND, a U.S. pilot study will evaluate the use of bioengineered vessels to provide vascular access in subjects with ESRD undergoing routine kidney dialysis. Primary endpoints of this study will be safety and efficacy of the vessels at six months. “If our clinical trial outcomes are similar to our preclinical results, then the Humacyte bioengineered vessel may provide an exciting improvement over synthetic grafts for vascular surgeons and our patients,” said Jeffrey H. Lawson, M.D., Ph.D., professor of Surgery and professor in Pathology, Duke University School of Medicine (Durham, NC). Dr. Lawson, a consultant to Humacyte, will be an investigator in the U.S. trial at Duke University.
Initial European Trials Underway
In the multi-center, first-in-human study in Poland, the first patients received bioengineered vessels in December 2012, and these bioengineered vessels were first used for dialysis in February 2013. A planned interim review by an Independent Safety Review Board of clinicians was completed in April 2013. The Board’s approval to proceed confirms that additional dialysis patients may be enrolled as planned, with the goal of completing enrollment this year.
If these data are replicated in the clinic, then the bioengineered vessel is expected to be of significant benefit to both surgeons and patients by offering decreased rates of vessel clotting as compared to synthetic grafts. Such clotting is the major cause of graft failures. Humacyte believes that bioengineered vessels could potentially provide significant cost savings to the healthcare system when used in ESRD by lessening the number of complications and subsequent procedures.
Preclinical Data Presented at AHA Webinar
The results of foundational preclinical studies were presented today at an American Heart Association (AHA) Emerging Science Series webinar [American Heart Association Emerging Science Series], in a paper entitled ‘Human Acellular Vascular Grafts: Preclinical Dataset Supports Bench-to-Bedside Transition of Tissue-Engineered Grafts for Hemodialysis Vascular Access.’ Preclinical data suggest that the technology will be associated with less vessel clotting and minimal infection compared with currently available alternatives. Further information is available in an AHA press release [AHA Release].
“The fact that these bioengineered vessels contain no living cells enables simple storage onsite at hospitals, making them the first truly off-the-shelf engineered grafts that have transitioned into clinical evaluation,” said Shannon L. M. Dahl, Ph.D., co-founder and vice president, Scientific Operations, Humacyte. “In these preclinical studies, bioengineered vessels were repopulated with cells and remodeled like living tissue.”
About Bioengineered Blood Vessels
Humacyte’s bioengineered blood vessels are manufactured in a novel bioreactor system. Bioengineered vessels are decellularized, thereby rendering them non-immunogenic and implantable into any patient. These bioengineered vessels may be stored for up to 12 months under standard refrigerated conditions, including on-site in hospitals. This makes them readily available to surgeons and patients, and eliminates the wait for vessel production or shipping. Bioengineered vessels have demonstrated excellent resistance to thickening in large animal models for up to one year, and the early clinical trials that are now underway will provide safety and efficacy data in patients.
[1] https://www.kidney.org/kidneydisease/aboutckd.cfm
[2] http://www.nlm.nih.gov/medlineplus/news/fullstory_134056.html
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