October 11, 2013
RESEARCH TRIANGLE PARK, N.C. — AlloSource, one of the nation’s largest non-profit providers of skin, bone and soft tissue allografts and the world’s largest processor of cellular bone allografts, and Humacyte, Inc., a pioneer in regenerative medicine pursuing development of investigational bioengineered blood vessels, announced today that they have entered into a long-term strategic manufacturing partnership. According to the agreement, AlloSource will become the sole manufacturing partner to create Humacyte’s investigational bioengineered blood vessels being developed for hemodialysis applications.
Humacyte, a developer of novel human tissue-based products for potential applications in regenerative medicine and vascular surgery, uses innovative technology to create the first investigational biological replacement vessels that are being developed to be stored “off-the-shelf” for future use. Subject to ongoing research and development and future regulatory approval, Humacyte’s investigational bioengineered vessels could be used to create a vascular graft option available for patients on demand. These investigational bioengineered vessels are produced using donated human vascular cells and then decellularized to remove the donor identity from the newly created vessels. This process results in the production of investigational human vascular grafts with the potential to be implanted into any patient at the time of medical need.
“AlloSource’s cellular allograft expertise, as well as advanced tissue processing and manufacturing techniques, perfectly positions us to collaborate with Humacyte in continuing the pioneering R&D on their exciting technology,” said Thomas Cycyota, president and chief executive officer, AlloSource. “We look forward to working together to honor the gift of tissue donation by using it in a new way to create something that could have the potential to become a progressive, life-saving product for patients in need.”
The first investigational bioengineered vessel is being developed with the goal of approval for use in patients with chronic kidney disease, a major global health problem that affects 26 million Americans. Patients that progress to end-stage renal disease require renal replacement therapy (hemodialysis or kidney transplant). Today there are more than 380,000 patients who currently require hemodialysis in the United States.
“Through this collaboration with AlloSource, we believe we can build upon Humacyte’s leadership position in vascular tissue engineering with the future market introduction of this innovative, investigational bioengineered blood vessel technology following completion of clinical development and receipt of regulatory approval,” said Carrie S. Cox, chairman and chief executive officer, Humacyte. “AlloSource has a pre-eminent reputation as a leading provider and supplier of allografts and, together, we are joining forces to further establish a solid foundation with this technology for addressing the broad and diverse needs of patients and physicians.”
In 2012, Humacyte submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a multi-center U.S. clinical trial, involving up to 20 patients across three sites, to assess safety and performance of Humacyte’s investigational bioengineered vessel to provide vascular access for dialysis in End-Stage Renal Disease (ESRD) patients. That clinical trial is now ongoing, with the first investigational bioengineered vessel in the U.S. implanted in the arm of a kidney dialysis patient at Duke University Hospital in June 2013. This implantation represents a milestone in the field of vascular tissue engineering development, as this technology could have the potential to help reduce or avoid surgical interventions and hospitalizations for patients with ESRD.
Separately, a multi-center, first-in-human pilot study is underway in Poland to initially evaluate the safety and performance of investigational bioengineered vessels for dialysis access. Future clinical trials, in support of marketing applications in both the US and Europe, are planned after the completion of these initial studies. Subject to the successful completion of clinical development, commercialization of the hemodialysis graft currently is targeted for 2017 contingent upon FDA review and approval. Follow-on development of this technology is planned in other vascular procedures, such as replacement or bypass of diseased vessels, vessels damaged by trauma or other vascular procedures.
AlloSource is a non-profit company that offers more than 200 types of precise bone, skin, soft-tissue and custom-machined allografts for use in an array of life-saving and life-enhancing medical procedures. As the world’s leader in fresh cartilage tissue used for joint repair and skin allografts to heal severe burns, AlloSource has grown into one of the largest tissue networks in the country with more than 400 employees. It is the world’s largest processor of cellular bone allografts and delivers unparalleled expertise and customer service to its growing network of surgeons, partners and the country’s most reputable organ procurement organizations. As one of the leading innovators in maximizing tissue donation with the goal of offering optimal solutions for healthcare providers and their patients, AlloSource is recognized by the medical community for its ability to process and provide high quality tissue. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website, allograftpossibilities.org.
Humacyte, Inc., a privately held company founded in 2005, is a medical research, discovery and development company with clinical and pre-clinical stage investigational products. Humacyte is primarily focused on developing and commercializing a proprietary novel technology based on human tissue-based products for key applications in regenerative medicine and vascular surgery. The company uses its innovative and proprietary platform technology to engineer human, extracellular matrix-based tissues designed to be shaped into tubes, sheets, or particulate conformations, with properties similar to native tissues. These are being developed for potential use in many specific applications, with the goal to significantly improve treatment outcomes for a variety of patients, including those with vascular disease and those requiring hemodialysis. The company’s proprietary technologies are designed to result in off-the-shelf products that, once approved, can be utilized in any patient. The company web site is www.humacyte.com.