By Janet Coulter, MSN, MS, RN, CCM, FCM

In July 2025, the U.S. Food and Drug Administration approved a groundbreaking clinical trial allowing select biotechnology companies to use genetically modified pig livers as a dialysis-like treatment for patients with liver failure. While this may sound like science fiction, it is very much rooted in decades of scientific exploration. This carries enormous implications for patients with liver disease. 

According to Andrew Klein, MD, MBA, Chief Medical Officer of UNOS and a former liver transplant surgeon, this innovative approach represents a revitalized version of a technology first explored in the 1970s: xenoperfusion. Xenoperfusion is the process of circulating a patient’s blood through an external animal organ to perform critical functions. Dr. Klein explains that the treatment works by filtering a patient’s blood through a genetically modified pig liver to remove toxins, excess fluids, and other harmful byproducts. The FDA-approved trial will include up to twenty patients who do not qualify for liver transplant. The goal is to evaluate whether this intervention can stabilize or improve their condition. For case managers working with complex hepatic patients, this represents a potential shift in how we think about bridging therapies, resource allocation, and transition planning. 

Today, with advances in genetic modification and bioengineering, this treatment is reemerging with renewed promise. This opens a new chapter in bridging care for liver failure patients who have few (if any) viable treatment options. Unlike kidney disease, where dialysis can support patients for years, no parallel therapy exists for the liver. When liver failure progresses, options are limited to supportive care or emergent transplantation. Thousands of individuals die each year waiting for a liver that never comes. This new pig liver based technology aims to fill that gap. 

Dr. Klein recounts a compelling early experience that demonstrates the potential impact of xenoperfusion. In the early 1990s at Johns Hopkins, he treated a woman with acute liver failure who had fallen into a coma. Without a donor liver immediately available, his team made a bold decision. They revived the 1970s-era xenoperfusion technique using a pig liver obtained through research-approved channels. Minutes after the treatment began, the patient awakened. The pig liver eventually deteriorated, but the additional hours it provided proved lifesaving. A deceased donor liver became available, the transplant was successful, and the patient ultimately returned home. That extra few hours made the difference between life and death. 

Past xenoperfusion efforts were limited by immune reactions, ethical constraints, and the fragility of using non-modified animal organs. Today’s genetically engineered pigs are specifically designed to reduce rejection and improve durability. As Dr. Klein notes, this could make the treatment more stable, more predictable, and more widely applicable. 

Dr. Klein highlights two major applications: 

1. A Bridge to Transplant 

The treatment may stabilize patients long enough for a suitable donated liver to be identified. Even a few hours or a few days could change outcomes dramatically. 

2. A Standalone Treatment 

Some patients’ livers can regenerate when given time and metabolic support. If xenoperfusion allows the liver to recover and resume essential functions, a transplant might be avoided altogether. 

As xenotransplantation and xenoperfusion technologies advance, case managers will continue to play a vital role in bridging science with compassion. Case managers must remain informed, adaptable, and ready to guide patients and families through rapidly evolving possibilities in liver care. Whether helping families navigate the unknown, collaborating with multidisciplinary teams, or advocating for equitable access to innovative therapies, case managers remain at the heart of patient-centered transplant care. 

This FDA-approved pig-liver trial is more than a scientific milestone. It is a testament to the power of innovation and a reminder that even the most complex challenges can be met with hope, creativity, and collaboration. 

Stay tuned! 

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Bio: Janet Coulter, MSN, MS, RN, CCM, FCM is President of CMSA. She is a transplant case manager with a wide variety of experiences including educator, administrator, team leader, and Director of Case Management. Janet holds a Master of Science in Nursing from West Virginia University and a Master of Science in Adult Education from Marshall University. She has published many articles in CMSA Today and the Professional Case Management Journal and served as a reviewer for the Core Curriculum for Case Management Third Edition. She has served as President-Elect of CMSA, Chair of the CMSA Today Editorial Board, Chair of the Nominations Committee, and Vice-President of the CMSA Foundation board. Janet was the recipient of the CMSA National Award of Service Excellence and Southern Ohio Valley CMSA Case Management Leadership award and was recently inducted as a Case Management Fellow from CMSA.