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Medicine Science

FDA Testing Artificial Liver 146

Posted by samzenpus
from the with-artificial-onions dept.
NIckGorton writes "Research is now underway in the US to seek FDA approval for an artificial liver. The Extracorporeal Liver Assist Device (ELAD) filters blood through a cartridge containing immortalized human liver cells with fiber tubes running through that allow the patients blood to interact with them. This allows the matrix of liver cells to perform both the metabolic (cleansing the blood of toxins/waste) and synthetic (producing albumin, clotting factors, etc) functions of the patient's failing liver. A small trial in China showed a statistically and clinically significant difference in 30 day survival with ELAD."
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FDA Testing Artificial Liver

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  • by Zymergy (803632) * on Wednesday February 04, 2009 @09:29PM (#26732255)
    Obligatory: http://www.youtube.com/watch?v=aclS1pGHp8o [youtube.com]

    "Don't worry, there's nobody who's had their Liver taken out by Us who's survived."
    • This is great. I can start drinking again!

      • Re: (Score:3, Interesting)

        by cayenne8 (626475)
        "This is great. I can start drinking again!"

        I hear ya, first thing I thought of!!

        I live in New Orleans, where drinking is part of the way of life here. I used to never have a problem with hangovers, till about 2 years ago...when I first discovered what one REALLY was. And in he past year, after only 4-5 beers, I can be laid up with a hang over for next day. I joking tell people I think I blew a liver last year....

        Nice to know they may have a back up for me in a few years...

        • Nice to know they may have a back up for me in a few years...

          Ha ha, very funny! My chemo, for liver disease caused by blood products that were gathered at Arkansas, and later, Louisiana prison systems, comes to an end in two weeks (then follow-up). Those blood products cleared the FDA, despite not having been tested for hepatitis and HIV. Tests which were in existence for at least several years at that point. Connaught Labs. Blood is a billion dollar business, and nothing is as crucial to living as the func

  • Yum (Score:1, Funny)

    by Anonymous Coward

    Now if we could just get some artificial onions to go with that...

    • Re:Yum (Score:5, Funny)

      by Holi (250190) on Wednesday February 04, 2009 @09:38PM (#26732331)

      I was feeling more like fava beans, and maybe a nice chianti.

      • by Slumdog (1460213)

        I was feeling more like fava beans, and maybe a nice chianti.

        Infact at first glance, I thought it said "FDA Tasting....". Funny And btw, why are they testing in China?

        • And btw, why are they testing in China?

          It might have something to do with the fact that so many millions of people in China have liver diseases. The estimate on just Hepatitis B is around 130 million. A lot of traditional Chinese medicine revolves around liver treatments, probably because "as goes the liver, so goes the rest." So there's a huge population to use in the understanding of all sorts of issues related to liver function.

          Hepatitis C was first isolated in the late 70s, I think. The first test for

    • by tomhudson (43916)

      Now if we could just get some artificial onions to go with that...

      Ketchup. LOTS of ketchup. Anything to hide the taste.

    • by HTH NE1 (675604)

      Do they have any idea what this will do to the liver and onion market on Reticula?

  • by gmuslera (3436) on Wednesday February 04, 2009 @09:36PM (#26732309) Homepage Journal
    And they take your blood... wooden stake anyone?
  • Imagine... (Score:2, Funny)

    by CapsaicinBoy (208973)

    Just imagine... a beowulf cluster of cancer cells! Woo!

  • Until they test... (Score:1, Insightful)

    by symbolset (646467)
    Until the FDA starts making food safe, I have no interest in their medical findings. I'm not sick YET.
  • IMMORTAL! (Score:4, Interesting)

    by iluvcapra (782887) on Wednesday February 04, 2009 @09:38PM (#26732329)
    I for one, and this might just be my superstitious self, would be concerned about the prospect of my bodily fluids interacting with biological material that has been, so to speak, "immortalized."
  • by Trillan (597339) on Wednesday February 04, 2009 @09:42PM (#26732343) Homepage Journal

    I'll drink to that!

    • Re: (Score:3, Funny)

      by ibbie (647332)
      Kind of ironic that they're doing the trial in China - now the test subjects can have their very own drunken immortal. :D
    • Re: (Score:1, Insightful)

      by gormanw (1321203)
      Let's not forget that iron lungs and dialysis machines started this way. The liver is an amazing organ and has great regenerative properties. However, it can be easily damaged and transplants aren't very successful. It is sad that China, known for organ harvesting, has led the research on this.
  • Sweet! (Score:2, Insightful)

    by Anonymous Coward
    I do believe I'll have another Manhattan!
  • by Bruce Perens (3872) * <bruce@perens.com> on Wednesday February 04, 2009 @09:50PM (#26732417) Homepage Journal
    Hm, immortal. How is that different from cancerous? And all of the immune cells are really carefully filtered out so there's no potential for graft-vs-host disease if one gets loose in the patient, right?
    • by dondelelcaro (81997) <don@donarmstrong.com> on Wednesday February 04, 2009 @10:33PM (#26732733) Homepage Journal

      Hm, immortal. How is that different from cancerous?

      Cell immortality is orthogonal to the abnormal replication present in cancerous cells. There are lots of cells in your body which are effectively immortal but do not undergo abnormal replication, and are therefore not cancerous. [Obvious examples are your spermatogonia and progenitor cells in your bone marrow.]

      As far as immune cells go, so long as you've avoided including proliferative immune cells, you should be free from graft vs host issues. Growing the hepatocytes from cell lines that have been sorted pretty much guarantees this.

      • Re: (Score:3, Interesting)

        by Rich0 (548339)

        Yes, but the immortal liver cells in this device could very well be cancerous. Isn't the most common method for immortalizing cell lines in the lab to fuse the desired cell with cancer cells to form an immortal hybrid (selecting for the hybrids by both immortality and a genetic marker)?

        I think that great care would need to be taken to make sure that the cells never leak into your blood stream. That shouldn't be too hard with the right engineering, but there certainly is some cause for concern.

        • by dondelelcaro (81997) <don@donarmstrong.com> on Wednesday February 04, 2009 @11:24PM (#26733157) Homepage Journal

          Yes, but the immortal liver cells in this device could very well be cancerous.

          Sure, but they don't have to be. (Car analogy: Ferrari's are often red, but they don't have to be.)

          Isn't the most common method for immortalizing cell lines in the lab to fuse the desired cell with cancer cells to form an immortal hybrid (selecting for the hybrids by both immortality and a genetic marker)?

          Not really. What you're talking about is a hybridoma, which is generally used in the formation of monoclonal antibodies. As far as what method is actually used to produce the line, it really depends on what you want a cell line for. (Cell lines are immortal by definition, by the way; they don't get immortalized.)

          Most common cell lines are actually just isolated from various kinds of tumors, though.

      • by reverseengineer (580922) on Wednesday February 04, 2009 @11:42PM (#26733307)
        It should be noted that the liver cells used in this device are most certainly cancer cells- the HepG2/C3A line was originally grown from a hepatocellular carcinoma cell taken out of a 15-year old boy. You can buy some here [atcc.org] in fact.

        Use of these cancer cells in an artificial liver does create the risk of transfer to the patient, but the cells in question will be suspended in a collagen matrix, and is kept separate from the blood by a dialysis-type semipermeable membrane. Contracting cancer from this device requires that the dialysis membrane fail, that cancer cells get out of the collagen and into the filtrate, that the cancer cells are not caught by the dual membrane cell filter, and that once in the body, a cancer cell from a line noted for low tumorigenic potential implants somewhere and begins to form a tumor. Not impossible, but it is unlikely.
        • by Anonymous Coward on Thursday February 05, 2009 @12:45AM (#26733773)

          Also very important to note is that anyone who is getting this treatment is going to be seriously ill to begin with, and without it will be dying. I'm sure that they'll consider a chance of getting cancer is a small price to pay.

        • by sjames (1099)

          And of course, if it really means the difference between life and death, that tiny risk is certainly worth it.

        • In addition, the liver is composed of cells that are almost certainly incompatible with the patient ; any stray cells that manage to get through all those formidable layers of physical protection are going to be mercilessly exterminated by even the weakest immune system.

          This is the reason for keeping the liver separate from the patient behind a dialysing membrane in the first place - otherwise their immune system will kill it in very short order.

        • by Fnkmaster (89084)

          Cancer cells that aren't the patients cells are highly, highly unlikely to result in a cancerous growth unless a patient is highly immunocompromised. An even marginal functional immune system can recognize cells that are not of the host organism and attack them. The reason cancer is dangerous is that the cells are your own and thus the immune system doesn't recognize them as "other" and attack them.

          Thus the fact that cancer, in general, is not contagious. There are certain very rare exceptions that have

  • Artifical Liver (Score:3, Interesting)

    by Anonymous Coward on Wednesday February 04, 2009 @09:52PM (#26732431)

    As a two time kidney transplant recipient myself, I know how hard it is to live with organ failure. I met a guy who had gone through 3 liver transplants, and hepatitis had killed all of them. He is all right now,on his fourth transplant, but something like this can make all the difference in the world to people waiting for a liver. Especially since he had two small daughters.

    • Interesting also that this is kind of a hybrid. The outside is artificial but the actual operating cells are normal liver cells.

      Makes me wonder about building an artificial heart powered by normal muscle. It would solve the power supply problem.
      • The heart IS a muscle... the trick would be building an artificial heart powered by the body's own nervous energy, or somehow replacing the vulnerable cartilage and passageways of the heart with artificial materials. Besides, a lot of heart issues are with the muscle itself, beginning with arrhythmia and the like. Building an artificial muscle that's powered by the existing bodily systems, now there's a trick and a half.

    • Re: (Score:2, Interesting)

      by Anonymous Coward

      So who is this guy that he's been pushed to the front of the queue waiting for a liver transplant not just once, but three more times?

      According to the United Network for Organ Sharing (UNOS) there are currently more than 17,000 people waiting for a liver transplant in the US. And only 5,300 transplant operations per year (2002 data) are being performed.

      If hepatitis has, indeed, destroyed each of the multiple donated organs placed into this bozo, it's time for him to step aside and to give someone else a ch

    • >As a two time kidney transplant recipient myself, I know how hard it is to
      >live with organ failure. I met a guy who had gone through 3 liver transplants

      A serious question:

      With donation organs being the rarity that I've heard they are, and so many people I've heard are on waiting lists to get them, how does one successfully make the cut for 2 or even 3 organs?

      • I heard that some people have rare tissue types that are hard to match. By implication that means others are easier to find a match for?

        Then again, statistically there'd be more people with those types waiting for transplants, so it'd cancel out.

        Perhaps the GP could enlighten us? Or someone in the business explain how they choose who gets the bits?

  • by interkin3tic (1469267) on Wednesday February 04, 2009 @09:56PM (#26732471)

    A small trial in China showed a statistically and clinically significant difference in 30 day survival with ELAD.

    So more people with this ELAD liver replacement were alive at 30 days than a control group, who presumably had their livers removed and replaced with nothing...

    • It's about time people started doing this research. It's been woefully lacking in the last few decades.
      • a control group, who presumably had their livers removed and replaced with nothing...

        It's about time people started doing this research. It's been woefully lacking in the last few decades.

        Yeah, ever since Nazi Germany fell, mad science just wasn't what it used to be... *sigh*

    • by Jay L (74152) *

      a control group, who presumably had their livers removed and replaced with nothing...

      Don't be ridiculous. They use sugar pills.

      (Or Folger's crystals!)

  • "Immortalized"? (Score:4, Insightful)

    by Mr. Roadkill (731328) on Wednesday February 04, 2009 @10:04PM (#26732519)

    Nice way of saying "we're replacing your bad liver cancer with a good liver cancer in this handy take-home plug-in box".

    • Re:"Immortalized"? (Score:5, Interesting)

      by spacefiddle (620205) <spacefiddle AT gmail DOT com> on Wednesday February 04, 2009 @10:13PM (#26732589) Homepage Journal

      we're replacing your bad liver cancer with a good liver cancer

      Ultimately, as we understand more, i believe the mechanisms of cancer will be more harnessed than eliminated.

      • by Pentagram (40862)

        My understanding of cancer (IANAO and I may not entirely know what I'm talking about here) is that there is no "mechanism" as such -- it's simply uncontrolled cell growth. Generally it occurs when a cell's genes that limit its growth or cause apoptosis get corrupted.

    • You know, if you have 30 days to live because of liver failure, I think getting cancer is worth extending that by a few months...

      • You know, if you have 30 days to live because of liver failure, I think getting cancer is worth extending that by a few months...

        Here's the thing. You wouldn't actually have cancer if on this device, not unless the barriers between the blood flow and the cultured liver cancer cells allowed these immortalised cells to enter your body and lodge somewhere else. Then, depending on how well your own immune system took care of the invaders, you could be in *real* trouble. If we're talking about something that most people can't reject there could be real problems - especially if it becomes transmissible, as has been observed with certain ca

  • Immortal cells - the deadliest cleansing force in all of Asia. We put their name to the test.
  • ...save the liver! [hulu.com]

  • by rlseaman (1420667) on Wednesday February 04, 2009 @10:20PM (#26732633)

    There's no information about the interface of this device to the patient. Blood flow to the liver is rather unique (http://biology.about.com/library/organs/bldigestliver.htm [about.com]), with 3/4 of its bloodflow coming from the portal vein and 1/4 from the hepatic artery. The blood mixes before being processed by the liver.

    Is the device similarly fed by both arterial and venous sources? How is the pressure compensated? Where is the output reintroduced? Does the device run in parallel to the natural liver or in series? If the latter, which receives the blood first? Does it attempt to handle any of the other numerous functions of the liver such as the creation of bile or lymph?

  • The product line itself will vary in capability and price. From the basic "Joe Sixpack" model, you can move up to the "Jazz Musician". If you've got enough money you can go all the way up to the full "Kieth Richards" model.

    • by Muad'Dave (255648)

      ...all the way up to the full "Kieth Richards" model.

      Does it prevent you from being killed by mortal weapons, or just any snorted, injected, inhaled, or eaten compound?

  • by MikeUW (999162) on Wednesday February 04, 2009 @10:25PM (#26732665)

    I think I'd just ask if they could immortalize all of my body's cells.

  • Some background (Score:5, Interesting)

    by necro81 (917438) on Wednesday February 04, 2009 @10:29PM (#26732685) Journal
    Some background on why an artificial liver is a really big deal, and why it has been really hard until now to produce one:

    (Any doctors or biologists more knowledgeable can fill in the gaps and correct me)

    The liver breaks down toxins in the blood by metabolizing them. That is, they get broken down into simpler compounds by chemical reactions that take place in and around living cells. Contrast this with dialysis - an artificial kidney - which is able to work by filtering out chemicals based on molecular weight. Dialysis uses bundles of membranes that allow relatively light molecules (such as water) to pass through, but block heavier ones. The stuff the liver breaks down are too unwieldy or complex to be filtered out based just on weight - there are lots of other, good things in the blood that are of similar weight or complexity. A simple filter can't distinguish them; hepatocytes (liver cell clusters) can.

    The task of creating the filtering membrane of a dialysis machine is a relatively well understood materials and processing problem. An artificial liver, which usually has a mini dialysis unit on the front or back end, also requires you to have living clusters of cells, and keep them alive, nourished, and healthy long enough for them to do some effective and therapeutic blood filtering. That's a much trickier biological problem, and we are only now getting decent at it.

    The uses for a bio-artificial liver is huge. It can help people with chronic liver failure live longer and healthier lives, true, but it has more uses than that. The liver, as it turns out, is one of the few organs that can regenerate itself. If it is damaged by disease or some toxic insult, it is possible for it to repair itself if given the chance (in normally healthy people - the liver can also be damaged beyond repair). The problem is that in lots of cases the patient will die before the liver gets a chance to heal, leaving two options: hope for a liver transplant on really short notice, or die. A device like this can be a bridge to transplant or, in some cases, take the burden off the liver long enough for it to heal itself.
    • by az-saguaro (1231754) on Thursday February 05, 2009 @01:14AM (#26733913)

      See also the comments above by rlseaman - this will address those as well.

      The liver has multiple functions for both biochemical synthesis and detoxification. Unlike most organs and tissues, it has two circulatory inflows. The arterial circulation is the nutritive blood supply, just as the arterial circulation for any tissue. A portal circulation is one in which the venous effluent from a tissue does not return directly to the systemic circulation, but instead detours through another organ first. There are two portal circulations in most chordates - the hypothalamic-pituitary circulation, and the splanchnic portal system. The purpose of the splanchnic portal is to take raw digestate absorbed from the gut, and pass it through a chemical filter (the liver) which will detoxify or eliminate nasty exogenous compounds before they get back into the general circulation (via the hepatic veins). The hepatic artery supplies the liver; the portal vein is the business of the liver. Detoxified products that must be eliminated from the body are excreted into the bile, which is eliminated through the gut. Without a liver at all, death will occur within just a few days, about 3-7.

      Renal failure is also lethal, but in the early 1950's, technologies were developed to keep renal failure patients alive - the dialysis machine. Dialysis is used as a bridge to organ transplantation, but for many people it is their permanent replacement kidney. It is an extraordinarily effective device. It could be "perfected" "back then" because the dialysis machine and the kidney are both relatively simple machines when it comes the elimination / detoxification aspects of its function. It depends simply on diffusion across semi-permeable membranes so that chemical concentrations can be equilibrated. No cells nor other active function is needed.

      Compare this to heart function. We can transplant hearts quite successfully, but unlike the kidney, we cannot keep people alive without their native heart. Attempts in the past 10-20 years to develop mechanical bridge devices have all been technical, medical, and ethical failures, awaiting some future technologies to make the concept truly feasible.

      The liver is in between. With regard to basic medical and ethical issues, an artificial liver should be comparable to the kidney. But technically and scientifically, making an artificial liver has been impossible until recently. Unlike the kidney, emulating liver function cannot be done by simple passive dialysis - the liver has MANY active chemical processes that must be actively metabolized. Attempts to run a patient's blood through a pig liver was the best available technology, and it doesn't work well at all, certainly not long term. What these researchers have done in this article is to mate living human cells to a dialysis device.

      From the company's description of the product, it sounds like a fairly standard dialysis cartridge to start with. The key element, something that was NOT technically possible until the biotech revolution that we are now going through, is to put living cells in the device. I presume that the dialysis membranes are much more "porous" than renal dialysis membranes, allowing bigger molecules to get across, but hepatocytes remain sequestered on their side - there is no chance of "mixing and migration". All modern biotech "living cell" products go through ELABORATE testing and purification to get clean single cell lines. "Immortalized" means they have had their genome switched on so that they can mitose and replicate ad infinitum, without reaching the natural limits of mitosis that many differentiated cell lines have. Bile ducts, portal veins, and all that are not needed, because wastes come in through your normal arterio-venous dialysis shunt, and go out in the dialysis effluent. Because the device is not directly siphoning splanchnic blood, the clearance of potential dietary "toxins" is slower, but any patient with advanced liver disease has to make certain dietary adjustments anyway.

      • by Shihar (153932)

        Out of curiosity, what is the great challenge in producing an artificial heart? It would seem to me that sloshing some blood around to a regular rhythm in something blandly neutral to your body would be among the easiest of challenges.

        • Three big problems. One: It has to be absolutely reliable and able to run for long periods with refuelling/recharging (and also keep running while it's being refuelled/recharged). It stops, and you only have a few minutes to restore blood circulation. Two: it has to handle the blood gently enough so that it doesn't start clotting; this is not a trivial problem and includes much hard research to formulate the surfacing of all the blood vessels and chambers. Three: It all has to be damn small. This com

    • My mother has lived with Cirrhosis of liver for past decade(caused by a bad doctor prescribing painkillers for 6 months instead of proper diagnosis).
      This artificial liver could help her IF her body could accept it.
      Problem is FDA has a knack of approving stuff before it is really ready for real world. FDA is owned by pharma companies.

    • by Samah (729132)

      If it is damaged by disease or some toxic insult, it is possible for it to repair itself...

      Hey liver, yo' momma's so fat, she's immortal!

  • Clearly the usual joke is how business in the pubs will increase due to this. However, I think there may be some truth to the joke.

    Often times those with drinking habits/problems look for excuses as to why it is ok for them to drink. Some use silly rules such as I only drink after 5pm, others say they only binge on the weekends, and others say they are going to die anyway.

    Depending on how this is reported, we may begin to see people lower their inhibition, or at a minimum be willing to take more chances wit

  • albeit a not so pretty one...

    Currently hemophiliacs must give themselves a shot in order to obtain the factor 8 they need to complete the factor chain and make a clot.

    In an extreme accident where a person couldn't be able to give themselves the medicine immediately, the chances for survival drop greatly.

    Knowing that they could walk around like a normal person would be a god-send to these people.
  • Oi, the fake bacon kicks ass. The fake liver can't hold a candle to it, I don't care how many fiber tubes it contains.
  • Immortalized (Score:1, Redundant)

    by Hordeking (1237940)
    If they can immortalize liver, why can't they immortalize the rest of me?
  • You guys think I can get them to immortalize the rest of my cells?

    just asking......
  • by Anonymous Coward

    The FDA is only a regulatory body...this test is being run by Vital Therapies Inc along with a wide range of hospitals and research organizations

    Not the FDA...know the basics...

  • by FlyingSquidStudios (1031284) on Thursday February 05, 2009 @12:09AM (#26733509) Homepage
    "we didn't want to worry about medical ethics"
  • Christopher Hitchens will be so relieved.

  • Ok, seriously, the FDA is using material research from China? Whatever happened to the US doing it's own research?

    Say, I wonder if the FDA has contracted human cancer trials in Darfur.

    Seriously, human rights anyone?

  • funding (Score:3, Funny)

    by Lord Ender (156273) on Thursday February 05, 2009 @01:44AM (#26734063) Homepage

    Surprisingly, it was revealed that funding for liver replacement research was provided entirely by the liquor industry.

  • by vandelais (164490) on Thursday February 05, 2009 @02:02AM (#26734113)

    who asked the transplant surgeon if the donor was still alive, to which the surgeon replied

    "You're a sportswriter, aren't you?"

    won't feel like such a roob anymore.

  • ...the year of the cyborgs!
  • Liver modding and overclocking! YEAH!
  • The Scots have had this forever - Haggis [wikipedia.org] is a bag of liver (and lungs, and hearts, and oats and onions).
  • " A small trial in China showed a statistically and clinically significant difference in 30 day survival with LEAD."
  • Doctors also will ask if any benefit is big enough to cover what could be a $30,000 price tag.

    Is this per use or per machine? Can a single machine be refitted and used multiple times ( like a dialysis machine)?

    BBH
  • I'm thinking, pate that never goes bad.

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