Trestle Bio Partners with Humacyte to Advance Bioengineered Kidney Research
Trestle Biotherapeutics, Inc., a company dedicated to developing bioengineered kidney tissues for patients with end-stage renal disease (ESRD), has announced a significant research collaboration with Humacyte, Inc. Humacyte, a commercial-stage biotechnology platform, specializes in developing bioengineered human tissue at a commercial scale, including universally implantable tissues for medical applications. The two companies will explore synergies between their technologies, particularly focusing on bioengineering vascularized organs for transplantation.
Goals of the Collaboration
The primary objective of this collaboration is to integrate Trestle Bio’s biofabricated human kidney tissues with Humacyte’s acellular tissue-engineered vessel technology, ATEV™. This research collaboration and material transfer agreement aims to generate bioengineered kidneys with vascular perfusion, a critical component for making kidney tissues viable for implantation and long-term function in humans. The collaboration also provides an opportunity for both companies to expand their respective R&D programs and refine their technologies for future clinical applications.
Trestle Bio’s Innovative Kidney Tissue Development
Trestle Bio is at the forefront of developing implantable bioengineered kidney tissues for patients suffering from ESRD. The company’s biofabricated kidneys are designed to provide sufficient renal function for patients, potentially allowing them to be removed from dialysis. This groundbreaking technology could delay the need for a kidney transplant and, in the long term, form the foundation for creating transplantable bioengineered organs, helping to address the global organ shortage.
By using stem cells to biofabricate human kidney tissues, Trestle Bio hopes to create a sustainable and scalable solution for patients who currently rely on dialysis for survival. The company’s innovative approach holds the potential to improve the quality of life for millions of patients with chronic kidney disease (CKD) and ESRD by offering an alternative to organ transplantation.
Humacyte’s FDA-Approved Technology
Humacyte’s ATEV™ technology recently received FDA approval for use in adults as a vascular conduit for extremity arterial injury, particularly when urgent revascularization is needed, and autologous vein grafting is not feasible. ATEV™ is an acellular tissue-engineered vascular graft that has shown promise in a variety of clinical applications, including vascular surgeries and trauma care.
The FDA approval of ATEV™ is a major milestone for Humacyte and demonstrates the company’s ability to develop regenerative medicine products with clinical relevance. Trestle Bio sees this technology as highly complementary to its kidney biofabrication efforts, especially in integrating functional vascular networks into bioengineered kidney tissues to ensure their survival and function once implanted.
Addressing the Global Kidney Disease Crisis
Chronic kidney disease (CKD) affects more than 800 million people worldwide, with approximately 125,000 new diagnoses of kidney failure in the U.S. each year. Currently, over 600,000 patients in the U.S. rely on dialysis to stay alive, while approximately 100,000 patients are on the kidney transplant waiting list. Unfortunately, only about 25,000 successful kidney transplants occur annually, leaving a significant gap in supply.
Kidney transplantation remains the only definitive treatment for ESRD, but the ongoing organ shortage limits the number of patients who can receive a transplant. This collaboration between Trestle Bio and Humacyte could represent a major step forward in addressing the shortage of kidney organs by creating bioengineered alternatives that offer a sustainable solution for patients in need.
Statements from Company Leaders
Dr. Laura Niklason, Founder and CEO of Humacyte, expressed her enthusiasm for the collaboration, stating, “Trestle is doing cutting-edge work in a field that desperately needs innovation and risk-taking. We are excited to explore ways in which our teams can work together to catalyze the development of new solutions for addressing kidney failure.”
Dr. Ben Shepherd, co-founder and CEO of Trestle Bio, added, “We have been following Humacyte closely for some time now, and I think it’s fair to say that they are really the gold standard for developing an FDA-approved regenerative medicine product. We’ve been highly focused on developing our kidney stem cell biology and biofabrication programs, and this is a natural progression for us. The broad application of Humacyte’s ATEV™ technology to treat kidney disease patients is clear, and we’re excited to collaborate with Humacyte to start bringing these engineering concepts to life.”
The Future of Kidney Bioengineering
This collaboration between Trestle Bio and Humacyte is expected to drive significant advancements in the field of kidney bioengineering. The integration of ATEV™ technology with Trestle Bio’s biofabricated kidney tissues will be key to overcoming one of the biggest challenges in organ bioengineering—vascularization. A well-vascularized kidney is crucial for ensuring that the tissue receives adequate blood flow and remains functional post-implantation.
If successful, this partnership could not only transform the treatment landscape for ESRD patients but also open the door to new bioengineering applications in other areas of organ transplantation. Moreover, the successful development of bioengineered kidneys could help reduce the reliance on donor organs, alleviating some of the burden on the transplant waiting list and improving patient outcomes.
Conclusion
The collaboration between Trestle Bio and Humacyte marks a significant step forward in the development of bioengineered organs for transplantation. By combining Trestle Bio’s expertise in kidney tissue biofabrication with Humacyte’s proven ATEV™ vascular conduit technology, the two companies aim to create a sustainable solution for kidney failure, potentially changing the lives of millions of patients worldwide.
As research progresses, the integration of these innovative technologies could pave the way for a future where bioengineered kidneys and other organs are routinely used in medical practice, helping to address the growing global organ shortage and improving the lives of patients in need.
About Trestle Biotherapeutics
Trestle Biotherapeutics, Inc. is a preclinical stage company developing bioengineered tissues for patients living with end stage renal disease. Once implanted, these bioengineered stem cell-derived tissues will take patients off dialysis, delay their need for transplantation, and one day become replacement organs. Learn more at trestlebio.com.
About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of acellular tissue engineered vessels (ATEVs), are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication was approved by the FDA in December 2024.
Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel 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 FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. For more information, visit www.Humacyte.com.
