LyGenesis Is Using its Cell Therapy to Combat Liver Disease

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Liver disease is a major public health concern, affecting millions of people worldwide. According to the Cleveland Clinic, about 1 in 10 Americans (30 million in total) have some type of liver disease.1 About 5.5 million people in the U.S. have chronic liver disease or cirrhosis.1 LyGenesis has activated their Phase 2a clinical research trial utilizing allogeneic cell therapy for patients with End Stage Liver Disease (ESLD) (NCT04496479). The demand for liver transplants far exceeds the supply of available organs. The waiting list for a liver transplant can be extensive, with some patients waiting for months or even years before a suitable liver becomes available.2 What’s more, many patients do not qualify to be listed for a transplant due to a variety of comorbid conditions or other issues.3 Our first indication for our liver cell therapy program is for patients with ESLD who do not qualify for a standard liver transplant.

Potential Treatments for Liver Disease?

Many companies are working on innovative therapies as potential treatments for liver disease. Some of these technologies involve growing organs in pigs, and then genetically engineering them to make them more closely resemble their human counterparts. Known as xenotransplants, these animal-based organs are the focus of multiple companies trying to help patients with liver disease. In contrast, LyGenesis’s allogeneic cell therapy is derived from donated but discarded human organs, which serve as our cell source. LyGenesis has a proprietary cell processing program that extracts hepatocytes from donated organs and readies them for engraftment into lymph nodes. The patient’s lymph nodes act as natural bioreactors that transform over time from a lymph node into a functioning ectopic liver, helping to filter the patient’s blood and hopefully alleviate the signs and symptoms of their ESLD.

LyGenesis’ co-founder, Dr. Eric Lagasse, a world leader in ectopic transplantation research, pioneered the research that led to this breakthrough, as was detailed in Nature Biotechnology. He found that hepatocytes (liver cells) transplanted into lymph nodes would not just survive, but thrive, organize, and begin to function as miniature ectopic livers, exerting life-saving effects in otherwise fatal small and large animal models of ESLD.

LyGenesis’s technology leverages one donated organ that would otherwise be discarded to potentially treat up to 75 patients with ESLD. Hepatocytes are isolated and extracted and within 6 hours, the hepatocytes are ready to be transplanted in an outpatient setting via an endoscopic ultrasound (EUS) procedure. Compared to an orthotopic liver transplant that is considered major surgery, the EUS procedure is minimally invasive and performed under light sedation. Leveraging the natural biology of the lymph node, transplanted hepatocytes are able to engraft, proliferate, and form functioning ectopic organs that recapitulate the native liver’s function.

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References:

1. Cleveland Clinic: Liver Disease Health Library
2. National Institute of Diabetes and Digestive and Kidney Diseases: Liver Transplant Process
3. National Institute of Health: Recipient ineligibility after liver transplantation assessment: a single centre experience. DOI 10.1503/cjs.004512

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