Trestle Biotherapeutics, Inc. today announced a research collaboration with Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissue at commercial scale. Trestle Bio is a preclinical-stage company working on bioengineered kidney tissues for patients with end stage renal disease (ESRD). The collaboration will investigate potential technological synergies for bioengineering vascularized organs suitable for transplantation.
Under this newly announced research collaboration and material transfer agreement, the two organizations aim to identify avenues for integrating their respective technologies. By exploring how Trestle Bio’s biofabricated human kidney tissues interact with Humacyte’s acellular tissue engineered vessels (ATEV™), the groups seek to generate a human bioengineered kidney capable of vascular perfusion.
Trestle Bio is developing implantable, bioengineered kidney tissue intended to assist patients living with ESRD. The goal is for these stem cell-based tissues, once implanted, to offer sufficient renal function to eliminate or delay dialysis, postpone the need for organ transplantation, and provide a platform for future transplantable bioengineered organs to address the global shortage.
Humacyte recently received FDA approval for its ATEV™ to serve as a vascular conduit in adults for extremity arterial injury when urgent revascularization is necessary to prevent limb loss and when autologous vein grafting is not feasible.
Chronic kidney disease (CKD) affects more than 800 million individuals worldwide. In the United States alone, approximately 125,000 new cases of kidney failure are identified each year, and 600,000 patients rely on dialysis for survival. While kidney transplantation remains the definitive treatment, only 25,000 transplants are performed each year, despite a waiting list of around 100,000 individuals, reflecting an ongoing organ shortage.
Commenting on the collaboration, Humacyte Founder and CEO Laura Niklason, M.D., Ph.D., stated, “Trestle is working at the forefront of a field that urgently requires innovation. We look forward to collaborating and exploring new solutions to address kidney failure.”
Ben Shepherd, Ph.D., Trestle Bio’s co-founder and CEO, added, “Humacyte has established a strong position in the regenerative medicine space with its FDA-approved product. We have been concentrating on advancing our kidney stem cell biology and biofabrication programs, making this collaboration a logical next step. We see clear applications for Humacyte’s ATEV technology in treating kidney disease and are excited to begin this joint development effort.”
About Trestle Biotherapeutics
Trestle Biotherapeutics, Inc. is a preclinical-stage company focused on developing bioengineered tissues for individuals living with end stage renal disease. Once implanted, these stem cell-derived tissues are designed to remove the need for dialysis, delay transplantation, and ultimately function as replacement organs. For more information, visit trestlebio.com.
About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a biotechnology platform designed to deliver universally implantable, bioengineered human tissues, advanced tissue constructs, and organ systems. The company manufactures acellular tissues for a variety of diseases, injuries, and chronic conditions. Humacyte’s lead product candidates, a portfolio of acellular tissue engineered vessels (ATEVs), are in late-stage clinical trials for multiple vascular indications, such as vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in vascular trauma was approved by the FDA in December 2024. Research and development is also underway for coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes treatment, and other cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received Fast Track designation. The 6mm ATEV for urgent arterial repair after extremity vascular trauma and for advanced PAD have also been granted RMAT designations. The ATEV holds priority designation from the U.S. Secretary of Defense for treating vascular trauma. For uses other than the FDA-approved extremity vascular trauma indication, the ATEV remains an investigational product not yet approved for sale by the FDA or any other regulatory body.
Original article can be found here.
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