WATCH: Hepatocyte Transplantation into Lymph Nodes: A Novel Approach to End-Stage Liver Disease

Houston Methodist physician researchers are participating in a groundbreaking clinical trial testing whether hepatocyte transplantation into lymph nodes via endoscopic ultrasound can stabilize or even reverse liver failure in vulnerable patient populations.

The video above explores how the study, sponsored by the cell therapy company LyGenesis, represents an innovative step forward in addressing end‑stage liver disease, particularly for patients who have no viable transplant options or who are too unstable to undergo surgery.

“I have an interest in liver failure and bridging therapies for transplantation,” says Dr. Constance Mobley, associate director of Liver Transplantation at Houston Methodist J.C. Walter Jr. Transplant Center. “That's how we came to be involved with LyGenesis and this trial.”

Her team’s active research program in liver transplantation positioned Houston Methodist as a natural site for the potentially groundbreaking work.

Study design: safety first

As the site’s principal investigator, Dr. Mobley describes the Phase 2a trial as a dose‑escalation study where the first objective is clear: safety. “Initially the first bar to clear is that of safety.”

The opening cohort receives a low dose of cells, around 50 million injected into one lymph node. Subsequent cohorts will expand both the number of lymph nodes and the cell dose.

“The second cohort will have three lymph nodes injected," explains Dr. Mobley. "And then the third cohort will then have even more lymph nodes injected with more cells."

Clinically meaningful improvement is the next focus of the trial, called A Phase 2a, Open Label, Dose Escalation Study for Safety, Tolerability, and Efficacy of Hepatocyte Transplantation into Periduodenal Lymph Nodes Among Subjects with End-Stage Liver Disease. As Dr. Mobley notes, the team is looking for “a decrease in bilirubin levels, a decrease in aspartate aminotransferase and alanine transaminase, and an improvement in international normalized ratio.”

They also hope to see improvements in hepatic encephalopathy and possibly even some level of reversal of hepatorenal renal syndrome.

Early signals are encouraging. “This study actually so far has been successful," says Dr. Mobley.

Expanding options for vulnerable patient populations

One of the study’s most compelling potentials is its applicability to patients who fall between current therapeutic cracks. Dr. Mobley highlights individuals who have symptomatic liver disease but do not meet transplant criteria.

“We have patients ... who are very symptomatic and not candidates for transplantation because of their low Model for End-Stage Liver Disease score, or don't have easy access to organs," she explains.

This therapy may either reverse or stabilize symptoms until these patients are able to receive a transplantation. It may also serve critically ill ICU patients who must be stabilized before being taken into the operating room.

Looking further ahead, Dr. Mobley sees potential for even earlier intervention:

“We may be able to intervene on patients at early times of diagnosis of cirrhosis," she adds, "possibly even before they have significant symptoms, and stabilize their disease before they decompensate and need transplantation at all."

A vision for the future of liver medicine

“When I see patients at the bedside and I see that there's a gap in the ability of us to be able to take care of them and get them back to health, then that immediately makes you want to think: How can I fix this? And that's what doing research is all about," Dr. Mobley says. “Within the next decade, my hope would be that we see far fewer patients who are succumbing to liver failure."