AlloSource, a 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, 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 million of Americans. Patients that progress to end-stage renal disease require renal replacement therapy (hemodialysis or kidney transplant).
"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."