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Extracorporeal cellular therapy ineffective for alcoholic hepatitis

Overall survival rates were not significantly different between patients with alcoholic hepatitis who received standard care and those who received extracorporeal cellular therapy with standard care, according to recently published data. However, younger patients with lower MELD may benefit from the treatment.

“To narrow the use of the limited organ pool, cellular therapies have been suggested as an alternative option to current medical treatment for [severe alcoholic hepatitis] by providing anti-inflammatory effects and promoting hepatocellular regeneration,” Julie Thompson, MD, MPH, from the University of Minnesota Medical Center, and colleagues wrote. “The concept of liver cell therapy in [severe alcoholic hepatitis] is based on the assumption that by providing hepatocellular support, the impaired liver cells can recover, inhibiting further degeneration and enabling recovery.”

To assess the efficacy of extracorporeal cellular therapy (ELAD), Thompson and colleagues prospectively enrolled 203 adult patients with severe alcoholic hepatitis who displayed a rapid onset of jaundice and coagulopathy.

The researchers randomly assigned 107 patients to receive standard of care — as defined by the American Association for the Study of Liver Disease and the European Association for the Study of Liver Diseases — and 96 patients to receive standard of care with (ELAD). The two groups were similar in use of steroids, use of systemic antibiotics for infections, and disease severity based on MELD or age.

After a minimum follow-up of 91 days, the researchers found no significant difference between overall survival in the ELAD group and the control standard of care group (47.9% vs. 47.7%). At study end, the rates were 51% in the ELAD group and 49.5% in the control group.

In a subgroup analysis, patients who were older and had a MELD score higher than baseline medians showed a trend toward worse outcomes. In contrast, patients younger and with a lower MELD score than baseline medians had better outcomes. Survival was significantly better in the ELAD group than the control group among patients with both MELD less than 28 and aged less than 46.9 years (100% vs. 73%; P = .006).

The number of patients who experienced treatment-emergent adverse events was similar between both groups, except the ELAD group had more instances of anemia (44% vs. 16%), thrombocytopenia (35% vs. 11%), coagulopathy (31% vs. 12%) and hypotension (31% vs. 17%).

According to the researchers, a confirmatory study is underway to investigate the reproducibility of the study’s results in patients with lower MELD and age.
by Talitha Bennett

Disclosure: Thompson reports she consults for Vital Therapies. Please see the full study for the other authors’ relevant financial disclosures.