WASHINGTON, D.C. The U.S. Food and Drug Administration (FDA) has approved a groundbreaking clinical trial that will test whether gene-edited pig livers can be used externally to filter the blood of patients suffering from acute liver failure much like dialysis for kidney patients.
The trial, spearheaded by Massachusetts-based biotechnology company eGenesis in collaboration with U.K. medical device firm OrganOx, represents a significant advance in the pursuit of xenotransplantation, the use of animal organs to support or replace human organ function.
Rather than implanting the pig liver, researchers will attach the genetically engineered organ externally to patients and pump their blood through it using OrganOx’s existing perfusion technology, which is currently used to preserve human donor livers. The goal is to determine whether the pig liver can temporarily support patients’ liver function, giving their own organs time to rest and potentially regenerate.
“There are an estimated 35,000 people in the U.S. hospitalized annually due to sudden liver failure,” said Mike Curtis, CEO of eGenesis. “The mortality rate can reach up to 50%, and many patients are either not eligible for a liver transplant or are unable to receive a donor organ in time.”
The trial, which is set to begin later this spring, will enroll up to 20 critically ill patients in intensive care units who are ineligible for liver transplantation. These patients will be connected to a system that circulates their blood through a pig liver, genetically modified to be more compatible with human biology.
In preliminary studies conducted using four deceased human bodies, the pig livers successfully supported several vital functions for two to three days. These encouraging results paved the way for the FDA to greenlight the upcoming live trial.
“The liver is the only human organ capable of regenerating itself,” Curtis noted. “We want to know if giving the liver a temporary break a few days of support could be enough to allow some patients to recover without needing a full transplant.”
This development marks another step forward in the evolving field of xenotransplantation. Other efforts by eGenesis and United Therapeutics have explored transplanting gene-edited pig kidneys into human patients as part of experimental life-saving treatments.
If successful, this new study could lead to a revolutionary support system for liver failure patients and a new chapter in bioengineered organ research.
Edgaroo Hernal started college at UP Diliman and received his BA in Economics from San Sebastian College, Manila, and Masters in Information Systems Management from Keller Graduate School of Management of DeVry University in Oak Brook, IL. He has 25 years of copy editing and management experience at Thomson West, a subsidiary of Thomson Reuters.
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