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Innovative Clinical Trial Explores Gene-Edited Pig Liver Support for Acute Liver Failure
WASHINGTON – U.S. scientists are poised to initiate a groundbreaking clinical trial to evaluate the potential of gene-edited pig livers to aid individuals experiencing sudden liver failure. This novel approach involves temporarily utilizing a pig liver to filter a patient’s blood, aiming to provide respite and promote healing in their own compromised organ. This innovative strategy could offer a new avenue for treating acute hepatic failure, a life-threatening condition.
FDA Approves Pioneering Xenotransplantation Study
The U.S. Food and Drug Administration has granted clearance for this first-of-its-kind clinical evaluation, according to eGenesis, the biotechnology firm specializing in genetically modified pigs, and its collaborator OrganOx. The companies publicly disclosed this significant regulatory milestone on Tuesday, marking progress in xenotransplantation research.
The Urgent Need for Liver Failure Treatments
Approximately 35,000 individuals in the United States are hospitalized annually due to abrupt liver impairment. This critical condition presents limited therapeutic options, resulting in mortality rates that can reach as high as 50%. A significant portion of these patients are not eligible for conventional liver transplantation or are unable to receive a compatible organ in time.
Novel Approach: External Pig Liver Support
The forthcoming study, anticipated to commence later this spring, represents a unique adaptation in the field of animal-to-human organ transplantation, also known as xenotransplantation. Researchers will not be performing a full pig liver transplant. Instead, the gene-edited pig liver will be connected externally to participants in the trial.
Harnessing Liver Regeneration with Xenograft Technology
The liver is distinguished as the sole organ possessing the capacity for regeneration. The central question this research seeks to answer is whether employing a pig liver to cleanse a patient’s blood for a defined period, potentially several days, can facilitate the natural recuperation process of their own liver.
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Preclinical Success in Supporting Liver Function
Initial experiments conducted using four deceased human bodies have demonstrated promising results. This “bridge therapy” approach indicated that a pig liver could effectively sustain certain essential functions of a human liver for a period of two to three days. This encouraging data was reported by Mike Curtis, CEO of eGenesis, the Massachusetts-based company that engineered these genetically modified pigs to enhance organ compatibility with humans.
Clinical Trial Design and Patient Enrollment
The upcoming trial is designed to enroll up to 20 patients admitted to intensive care units who are deemed ineligible for conventional liver transplantation, according to Curtis. A specialized device manufactured by the UK-based company OrganOx, currently utilized for preserving donated human livers intended for transplant, will be employed to circulate the trial participants’ blood through the external pig liver.
Progress in Xenotransplantation: Pig Organs for Human Therapy
This clinical study represents the latest advancement in the ongoing endeavor to utilize gene-edited pig organs to address critical human health needs and potentially save lives. Pig kidneys sourced from eGenesis, along with another company, United Therapeutics, are currently being utilized in separate experimental transplantation procedures, highlighting the expanding role of xenotransplantation in modern medicine. These ongoing efforts underscore the potential of genetically modified pig organs to offer solutions for organ shortages and life-threatening illnesses.