Liver Dialysis Clinical Trials Begin at University of UtahJun 11, 2014
Clinical trials for a breakthrough treatment for advanced liver disease are under way at the University of Utah. Liver expert Dr. Juan Gallegos reveals what this promising new therapy offers patients facing acute liver failure. As part of a worldwide study, this trial therapy is now available in the Intermountain region.
Interviewer: There's a brand new treatment for patients suffering from chronic or acute liver failure. We'll talk about that next on The Scope.
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Interviewer: There's a brand new treatment that are suffering from alcoholic liver related failure. We're talking with Dr. Juan Gallegos. He's a liver expert here at the University of Utah Hospital. You're really about this new possibility of this treatment which is in clinical trial right now. Tell me a little bit about what's going on.
Dr. Juan Gallegos: Thank you very much Scott. Yes we are very excited to participate in this clinical trial of this new therapy for patients with severe alcoholic liver disease. We're interested in it because alcoholic liver disease is very, very frequent in the United States. It's estimated that about two-thirds to three-quarters of adults in the United States drink some alcohol, most of them do so very mildly and moderately, but a subset of patients drink heavily and these patients are at increased risk of developing liver disease. And most patients have heard about alcoholic Cirrhosis and probably that's one of the top three causes of liver failure in the United States leading to liver transplantation.
But there is another entity called acute alcoholic hepatitis, or excessive alcohol drinking leads to significant inflammation and liver damage which could cause the liver to fail, and those are the patients that we're interested in studying and treating in this trial because up to until now the mortality for these patients, meaning the number of patients that die from this disease is about 70% six months after the initial episode. So there's a very dramatic impact of this condition.
Interviewer: And up until this point really no way to treat it, is that correct?
Dr. Juan Gallegos: Well there are some ways to treat it and mainly trying to get these patients abstinent from alcohol and that's the mainstay of treatment. Also adequate nutritional support is very important, and there's a couple of medical therapies that we can use that is medical medications that can be used to treat these patients, but even with that the mortality is still around 30 to 40% at 3 to 6 months after this episode of alcoholic hepatitis.
Interviewer: Okay so this is a dialysis machine, just briefly explain what this machine does then and why you're so excited about it?
Dr. Juan Gallegos: We're very excited about it because this is a machine that yes in a way is a dialysis machine; basically it is able to replace at least for a few days the major function of the liver. So basically what this company has made is a special machine where we have cartridges that are full of human liver cells that are alive and then can actually maintain the liver function for these several days, and these liver cells are grown here in the United States, and they're put in the special cartridges that go into this dialysis machine for the liver. The amount of cells there in these cartridges is equivalent to about 500 grams of liver tissue. Which is about a third of a normal liver.
Interviewer: Does it act as a filter, all those liver cells?
Dr. Juan Gallegos: They not only act as a filter they actually make proteins that are important for the normal physiologic function of the body so they make proteins that help with the clotting factors, they detoxify certain chemicals that are only detoxified by liver cells that in a patient that has acute liver failure are not working.
Interviewer: Is it like a respirator is doing the lungs job eventually this machine would be able to do the livers job?
Dr. Juan Gallegos: So what it can actually do the livers job for a few days but not more than that. Other machines that don't use liver cells really they only act like you mention as filters.
Interviewer: So traditional dialysis would be one of those machines?
Dr. Juan Gallegos: Traditional dialysis in a sense is such a machine is just that traditional dialysis can be used for long periods of time, and substitute the kidney function. The liver function is a bit more difficult to replace, and that's why this is so exciting. So what we are trying to see if it's this machine can help these patients over the hump of the severe or acute liver failure so that they can actually survive this episode and go on to either recover from the alcoholic liver disease, or if they don't necessarily recover but maintain their sobriety for a few months they can then go on to be considered for liver transplantation which we would be the definitive treatment for this alcoholic liver disease.
Interviewer: Yeah so the ultimate goal is the liver transplantation. This machine is by no means something you would stay on for the rest of your life.
Dr. Juan Gallegos: Correct that is not the case it's only basically to treat the acute episode and get you over this acute problem so that over time either you recover because sobriety is very important in some of these patients actually recover and if they maintain sobriety their liver can get back to almost normal.
Interviewer: Really it will heal almost to precondition?
Dr. Juan Gallegos: It might, it depends on how advanced the condition is to begin with. So in those patients that already have severe liver disease, and on top of this have an acute insult they're less likely to recover, but there are patients that don't have a severe liver disease to begin with and if they can get over this acute insult they're livers will recover to a point where they might not require a liver transplant in the future. As long as they maintain their sobriety.
Interviewer: And this is cutting edge technology obviously because it's in trial, the FDA hasn't approved it yet.
Dr. Juan Gallegos: Correct.
Interviewer: The whole process you're going through is hoping to prove...
Dr. Juan Gallegos: Yes we're hoping to prove that this will increase the chances of patients surviving to the point that it will be better than what our current medical therapies are, and the FDA is very interested in this so they have allowed us to participate in this trial. It's a multi-centric trial in the United States, and there are other centers in Europe and other places of the world.
Interviewer: So if somebody was interested in this trial what would they have to do?
Dr. Juan Gallegos: Well generally it will be a physician, or somebody taking care of these patients, they would just need to contact us at the University of Utah. I am the principal investigator so I'm readily available as well as our research coordinators.
Interviewer: Any final thoughts on this topic?
Dr. Juan Gallegos: Well I think that it's important to recognize that alcoholic liver disease is a significant problem in the United States, and that episodes of acute alcoholic hepatitis can be deadly, and we're trying to improve that with this machine, and hopefully people out there will be interested in and contact us.
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