Slashdot Mirror


Scrutinizing a Stem Cell Trial

Wired News has an interesting discussion of a clinical stem cell trial with the CEO of Geron, a California based stem cell company. The author takes time to discuss some of the process and hurdles that are faced by a company who wishes to engage in early clinical trials. From the article: "After an hour of speaking to Okarma, fears of a half-baked trial dissipated. He readily answered my many questions. If he didn't have the animal data to answer a query, he didn't try to dance around that fact. Okarma outlined a structured but malleable trial. I initially had reservations about safety, but Okarma emphasized that if the animal data is not good, the study will not move forward until problems are addressed."

54 comments

  1. Rats can walk! by Eightyford · · Score: 3, Informative
    1. Re:Rats can walk! by McGiraf · · Score: 3, Funny

      I am sure all the rats are realy happy we humans do all this reasearch to cure them of all these diseases and injuries.

    2. Re:Rats can walk! by Eightyford · · Score: 2, Funny

      I am sure all the rats are realy happy we humans do all this reasearch to cure them of all these diseases and injuries.

      They would probably be happier if we didn't intentionally paralyze them first!

    3. Re:Rats can walk! by Anonymous Coward · · Score: 0

      They would probably be happier if we didn't intentionally paralyze them first!

      Whiners.

    4. Re:Rats can walk! by GenieGenieGenie · · Score: 2, Funny

      I've always sought a career in making rats happier. Or was it humans? I not sure anymore. Anyways, you can leave some cheese outside this evening if it makes you feel better.

    5. Re:Rats can walk! by Anonymous Coward · · Score: 0

      They would probably be happier if we didn't intentionally paralyze them first!

      From The Onion:

      World's Scientists Admit They Just Don't Like Mice

      December 8, 2004 | Issue 4049

      ZURICH, SWITZERLAND--Nearly 700 scientists representing 27 countries convened at the University of Zurich Monday to formally announce that their experimentation on mice has been motivated not by a desire to advance human knowledge, but out of sheer distaste for the furry little rodents.

    6. Re:Rats can walk! by Gorshkov · · Score: 1

      I am sure all the rats are realy happy we humans do all this reasearch to cure them of all these diseases and injuries.

      In a related story, the next edition of Nature will contain the results of a new longditudinal study released by NIST.

      The most important parts of the study is it's conclusion that scientists are the leading cause of cancer in lab rats. There is also some speculation as to wether or not this would also apply to humans.

  2. Testing on bums by Eightyford · · Score: 3, Interesting

    I wonder where medical science would be if society allowed more testing on homeless people? (not that I condone that, of course)

    1. Re:Testing on bums by Anonymous Coward · · Score: 0

      That's what PETA is hoping for!

    2. Re:Testing on bums by pizzaman100 · · Score: 1

      Glad you clarified what kind of bum. Was worried there for a second.

    3. Re:Testing on bums by anndr0id · · Score: 1

      Or convicts... Why give someone the electric chair if they are a perfectly good specimen for testing?

    4. Re:Testing on bums by Anonymous Coward · · Score: 0

      Political considerations aside, we don't execute nearly enough people to get good enough data if we had enrolled them in trials instead.

  3. Summary by Otter · · Score: 2, Insightful

    Summary: This study had exactly the same oversight that every Phase I trial in the US has.

  4. What does it say about our society... by tverbeek · · Score: 3, Insightful

    What does it say about our society that I initially parsed "stem cell trial" in the headline as "a court case alleging illegal use of stem cells in research"?

    --
    http://alternatives.rzero.com/
    1. Re:What does it say about our society... by Eightyford · · Score: 1

      What does it say about our society that I initially parsed "stem cell trial" in the headline as "a court case alleging illegal use of stem cells in research"?

      That some people have a different set of morals and ethics than that of you and I?

    2. Re:What does it say about our society... by jtogel · · Score: 1

      People always blame society.

      The question is, what does it say about you?

    3. Re:What does it say about our society... by Anonymous Coward · · Score: 0

      that he's forced to deal with freakish religious zealots who care more about zygotes than living people on a day-to-day basis?

  5. You know what they say about Okarma... by objekt · · Score: 1

    What Ocomes around, Ogoes around.

    Will posting this hurt my excellent Okarma?

    --
    -- Boycott Shell
    1. Re:You know what they say about Okarma... by Eightyford · · Score: 1

      Will posting this hurt my excellent Okarma?

      Probably not. I get modded -1 Oflamebait and Otroll all the time and I still have excellent Okarma for some reason.

  6. When to believe by 1984 · · Score: 2, Insightful

    "I initially had reservations about safety, but Okarma emphasized that if the animal data is not good, the study will not move forward until problems are addressed."

    Don't believe that. Not because it's stem cells, not because Tom Okarma's a bad person (I have no idea about his character), but because that's not an independent, verifiable standard. Be happy that bad things should be avoided because some procedure is being followed and verified, not because you have a good feeling about a person. You want a process that deals with the honest folk and the dishonest folk just the same way, and works for both. Trust breaks the day you have a dishonest person on the other side of the table.

    Still, I guess this is offtopic. It's an interesting article.

    1. Re:When to believe by Anonymous Coward · · Score: 0
      You want a process that deals with the honest folk and the dishonest folk just the same way, and works for both.

      The writer is a narcissistic nitwit. Obviously the FDA relies on extensively documented and auditable toxicology and animal pathology results for approving an IND, for exactly the reason you say. Patients aren't expected to enroll in trials because the CEO seems like a nice guy.

      Your point isn't off-topic; it gets at why the whole article is inane, and frankly insulting to everyone else in pharma.

    2. Re:When to believe by se-wired · · Score: 1

      Still, I guess this is offtopic. It's an interesting article.

      Thanks 1984.

      BTW, my comment on trusting the safety of the trial has nothing to do with Okarma as a person (who I do not know well enough to judge), rather it was based on the fact that he expressed no reservations about addressing concerns that are raised about the safety before moving into human trials.

      --
      Steven / Wired News
    3. Re:When to believe by se-wired · · Score: 1

      The writer is a narcissistic nitwit.

      Yet you post as an Anonymous Coward.

      I was impressed with the deliberate contamination of the OPC1 cells with ESCs to see what would happen if a rogue ESC got loose, and some other comments that I failed to include in the Q&A. (The full transcript of the interview was right around 9600 words, so I had to condense a good bit.)

      --
      Steven / Wired News
  7. Stem cell trials? by btarval · · Score: 1

    Why in the world do we need trials? Aren't they all guilty?

    --
    The best way to predict the future is to create it. - Peter Drucker.
    1. Re:Stem cell trials? by psbrogna · · Score: 1

      While I don't think that "cells" should have any rights, I don't think we can consider them guilty unless they're part of a human. It does raise the question though, does a cell have to be born to possess "Original Sin?" Or does it have Original Sin if at any time it could have been part of a human at some point in the future... I should probably email the experts (office@net.va).

  8. You'll love it...it's a way of life by digitaldc · · Score: 0, Offtopic

    This is the CENTRAL SCRUTINIZER...it is my responsibility to enforce all the laws that haven't been passed yet. It is also my responsibility to alert each and every one of you to the potential consequences of various ordinary everyday activities you might be performing which could eventually lead to *The Death Penalty* (or affect your parents' credit rating). Our criminal institutions are full of little creeps like you who do wrong things...and many of them were driven to these crimes by a horrible force called STEM CELL RESEARCH!
    Our studies have shown that this horrible force is so dangerous to society at large that laws are being drawn up at this very moment to stop it forever! Cruel and inhuman punishments are being carefully described in tiny paragraphs so they won't conflict with the Constitution (which, itself, is being modified in order to accommodate THE FUTURE).
    I bring you now a special presentation to show what can happen to you if you choose a career in STEM CELL RESEARCH...

    --
    He who knows best knows how little he knows. - Thomas Jefferson
  9. What's so bad about stem cells? by Anonymous Coward · · Score: 0

    I just don't get it. Why does everyone complain about using stem cells? Are they anti-vegetarians? Why do scientists act like they're in rare supply? Except for trees, most plants I've seen have stems.

    --Average Slashdot reader

  10. Good. by posterlogo · · Score: 2, Interesting

    It's excellent that there are well balanced articles like this out there. Many tend to follow the anti-science trend that is taking over the US in recent years. Recently, the controversy over patient-specific stem cells has been used to rally the bible-beating troops against the use of embryonic stem cells altogether. Any sort of glance under the surface whatsover would immediately reveal that the scientific process worked exactly as it should, as it will in this clinical trial as well. Frankly, the results in animal models are quite promising, and if this treatment even mereley 'does no harm', I will be quite impressed.

    1. Re:Good. by MrFlibbs · · Score: 2, Insightful

      You must be easily impressed. Frankly, I was hoping for positive results like an improvement in sensation or motion in the patients. Not killing them is not much of an accomplishment. If there's no benefit to the patients from the treatment, why would you be impressed?

    2. Re:Good. by posterlogo · · Score: 2, Informative

      Actually, I'm a postdoctoral biologist. I'm not easily impressed. I think the concept of being able to introduce stem cells into human, and them not turn cancerous, really would be a marvelous achievement. Remember, stem cells are undifferentiated, a lot like tumor cells become. If the stem cells simply incorporate themselves into the tissue without any harm to the patient, I think that would be a huge accomplishment. It would verify the validity of the approach, and serve as a stepping stone for further research.

  11. Interesting job description by brian0918 · · Score: 4, Funny

    Wanted: Assistant for lab. Will be required to break spines of rats for further research. Flexible hours. Bring own hammer.

    1. Re:Interesting job description by Anonymous Coward · · Score: 0

      Finally! a chance to use this degree!

    2. Re:Interesting job description by Thing+1 · · Score: 1

      Wanted: Assistant for lab. Will be required to break own spine for further research. Flexible hours (you, not so much). Hammer (and adequate force) provided.

      --
      I feel fantastic, and I'm still alive.
  12. EMBRYONIC Stem Cell by Sethb · · Score: 1

    The description would be better served by noting that this is EMBRYONIC stem cell research, not just stem cell research, as there are "other" stem cell technologies already in use.

    --
    When in danger or in doubt, run in circles, scream and shout. --Robert A. Heinlein
    1. Re:EMBRYONIC Stem Cell by se-wired · · Score: 1

      Seth, they are embryonic, and that is discussed in the interview. The title can only be a certain length, so Embryonic was not included.

      Would you mind relaying to me which stem cell trials are curing paralysis?

      --
      Steven / Wired News
    2. Re:EMBRYONIC Stem Cell by jasondlee · · Score: 1

      Would you mind relaying to me which stem cell trials are curing paralysis?

      Like one? It's not perfect, as the article points out, but it's working for some people, which seems to satisfy your criteria.

      --
      jason
      Have a good day?! Impossible! I'm at work!
    3. Re:EMBRYONIC Stem Cell by se-wired · · Score: 1

      Unfortunately, that's a big misconception. Dr. Carlos Lima transplants the nasal mucosa, not stem cells.

      --
      Steven / Wired News
    4. Re:EMBRYONIC Stem Cell by jasondlee · · Score: 1

      "An experimental surgery using stem cells from adult organs is showing promise in helping patients paralyzed with spinal cord injuries."

      I'm no doctor, but I think they said stem cells from adult organs, and, even if the reporter hasn't a clue, there are also several stories regarding the successes of umbilical cord extractions, which are also not embryonic.

      --
      jason
      Have a good day?! Impossible! I'm at work!
    5. Re:EMBRYONIC Stem Cell by se-wired · · Score: 1

      The cells Dr. Lima transplants do come from an adult source, but characterizing them as stem cells is incorrect. I have written about this before.

      I have also written about the umbilical cord blood stem cell transplants.

      Interestingly, the surgery involved in both transplants involves decompression surgery. Decompression of a compressed cord, by itself, can lead to substantial gains.

      Of more interest, the doctors in South Korea are developing a percutaneous method of delivering the UCBSCs that will not involve surgery. When performed (preferably in a controlled study), this will definitely prove or disprove if it works.

      --
      Steven / Wired News
  13. Geron is not only stem cells by Anonymous Coward · · Score: 0

    By the way the telomerase stuff that Geron is working on will be even more spectacular. And it's closer to phase II (universal anti-cancer agent GRN163L).

  14. Same Mechanism of Action as Geron by se-wired · · Score: 1

    This treatment works the same way as Geron's. All-in-all, pretty cool.

    --
    Steven / Wired News
  15. Testicular cells coaxed into embryonic stem cells by Anonymous Coward · · Score: 0
    The Washington Post reported (Saturday, March 25, 2006) that German scientists (working under even more severe government restrictions than in the United States) have found a way to coax testicular cells from mice into the equivalent of embryonic stem cells. If this works in human males as well, this would bypass the pitfalls that occur when the body rejects donated transplant tissue and organs coming from others (adult or fetal). The article mentions that the search is underway for a similar feature in females. The article appears at the URL http://www.washingtonpost.com/wp-dyn/content/artic le/2006/03/24/AR2006032401721.html. (No registration required). Excerpts as follows:

    Scientists in Germany said yesterday that they had retrieved easily obtained cells from the testes of male mice and transformed them into what appear to be embryonic stem cells, the versatile and medically promising biological building blocks that can morph into all kinds of living tissues. ...
    And the cells passed every gold-standard test used today to prove their equivalence to embryonic stem cells. ...
    German scientists have great incentive to find alternatives to human embryonic stem cells, because government restrictions on human embryo cell research in Germany are even more severe than they are in the United States, where federally funded scientists are banned from working on embryonic stem cell colonies created after August 2001.


  16. Testicular cells coaxed into embryonic stem cells by Anonymous Coward · · Score: 0
    The Washington Post reported (Saturday, March 25, 2006) that German scientists (working under even more severe government restrictions than in the United States) have found a way to coax testicular cells from mice into the equivalent of embryonic stem cells. If this works in human males as well, this would bypass the pitfalls that occur when the body rejects donated transplant tissue and organs coming from others (adult or fetal). The article mentions that the search is underway for a similar feature in females. The article appears at the URL http://www.washingtonpost.com/wp-dyn/content/artic le/2006/03/24/AR2006032401721.html (no registration required). Excerpts as follows:

    Scientists in Germany said yesterday that they had retrieved easily obtained cells from the testes of male mice and transformed them into what appear to be embryonic stem cells, the versatile and medically promising biological building blocks that can morph into all kinds of living tissues...And the cells passed every gold-standard test used today to prove their equivalence to embryonic stem cells...German scientists have great incentive to find alternatives to human embryonic stem cells, because government restrictions on human embryo cell research in Germany are even more severe than they are in the United States, where federally funded scientists are banned from working on embryonic stem cell colonies created after August 2001.


  17. EMBRYONIC stem cells coaxed from TESTICULAR cells by Anonymous Coward · · Score: 0
    The Washington Post reported (Saturday, March 25, 2006) that German scientists (working under even more severe government restrictions than in the United States) have found a way to coax testicular cells from mice into the equivalent of embryonic stem cells. If this works in human males as well, this would bypass the pitfalls that occur when the body rejects donated transplant tissue and organs coming from others (adult or fetal). The article mentions that the search is underway for a similar feature in females. The article appears at the URL http://www.washingtonpost.com/wp-dyn/content/artic le/2006/03/24/AR2006032401721.html (no registration required). Excerpts as follows:

    Scientists in Germany said yesterday that they had retrieved easily obtained cells from the testes of male mice and transformed them into what appear to be embryonic stem cells, the versatile and medically promising biological building blocks that can morph into all kinds of living tissues...And the cells passed every gold-standard test used today to prove their equivalence to embryonic stem cells...German scientists have great incentive to find alternatives to human embryonic stem cells, because government restrictions on human embryo cell research in Germany are even more severe than they are in the United States, where federally funded scientists are banned from working on embryonic stem cell colonies created after August 2001.


  18. I for one welcome our Immortalized Cell Line by WillAffleckUW · · Score: 1

    Overlords, and worship at their ever-increasing telomeric overproductive DNA strand replicative feet.

    Or, I would, except I've noticed they have bizarre multi-nucleic aberrant patterns in later generations that makes it difficult to get mono-nucleic offspring in vivo as one would expect in the real world ...

    Nobody ever talks about some of the side effects of what we do to get these lines going, since we're not permitted to create new cell lines, as any decent scientific experiment would demand.

    --
    -- Tigger warning: This post may contain tiggers! --
  19. Not all propaganda is "anti-science" by cagle_.25 · · Score: 1
    FTA,

    Okama:We've got the world's only GMP master cell bank of human embryonic stem cells with lines that are fully qualified for human use which, by the way, are two of Bush's approved lines. So the stuff you hear published that all of those lines are irrevocably contaminated with mouse materials and could never be used in people -- hogwash. If you know how to grow them, they're fine.

    Perhaps some of the propaganda is anti-ethics in the name of science, poisoning the well towards those who have ethical objections and rallying the guys in lab-coats to oppose the "Bible-beaters"?

    Not that anyone does that on slashdot...

    --
    Human being (n.): A genetically human, genetically distinct, functioning organism.
  20. Bullshit by Maset · · Score: 1

    Okarma: It turns out that the differentiated cells that we make and put into animals are not recognized by the human immune system, and we published this last year. It's a striking finding.

    Without immunosuppressive drugs I don't believe this. And even without it *should* increase the chance of gaining M.S.

    There is a great pressure for scientists in this field to produce results (for money) and to move to clinical trials (because that is what motivates them, and what their backers want. But primarily it is what motivates them... to heal people). However, a lot of studies are very flawed, and it needs a lot of basic science to make sure that there are no repurcussions. Conversely the recipients tend to be the most desperate suffers, and this sways many ethics committees and researchers. I REALLY hope this works out for the best, but I am also deeply afraid it will cause more pain and suffering to the participants.

    Also, there is a LOT of money going into not only spinal cord repair... there is repair of: stroke; M.S.; peripheral nerve injuries; Parkinsons's disease; Alzheimer's disease; motor neurone disease, and others that I cannot remember at this time. All ove these need cell replacement therapy, and all will be aided with ALL research into this area. However, BASIC research is the one area in neural repair, injury, degeneration and replenishment that will aid ALL of these areas.

    I sometimes feel sick to my stomach at some of the studies that get published and then are lauded in the newsprint. However, I also get elation and hope from some others that offer true hope. I hope that this study is the latter.

    Cheers,
    maset

    1. Re:Bullshit by waynef2000 · · Score: 1

      Bravo, you must be a scientist. We continually look at stem cells, but the truth is one could look at cord blood and see a better response perhaps than with stem cells. As you know, when cells even begin to end stage differentiate, their ability to be incorporated into local tissue is reduced or eliminated. Further, many researc hers (myself included) believe that one needs the "gimmish" effect, i.e. having a natural "cocktail" of cells surrounding them. Finally, I believe that if there are no "chemoattractants" there is no reason to have stem cells aggregate in the affected area. with long term pathology, there is a tendency to down regulating the chemoattractants at the site of injury. In the end, I believe we will see more done in neurapathic disease with cord blood than with stem cells. You should look at the work of Paul Sanberg at University of South Florida for more data in this area. Best, WayneF2000

    2. Re:Bullshit by se-wired · · Score: 1

      Maset, here's the full portion of that section of the transcript:

      It turns out that the undifferentiated embryonic stem cell and the differentiating cells that we make and put into animals are not recognized by the human immune system and we published this last year. It's a striking finding.

      If I were to mix my blood with yours and yours with mine, my immune cells in that blood test would react against you because we're different HLA tissue types. As would you react to me and that's basically what happens if you were to take a kidney transplant from me or vice versa which is why organ transplants are traditionally associated with for life high dose immune suppression. These are allografts, in that the cells that we're gonna put into your spinal cord are made from what would have been an embryo with a different tissue type from yours so you're right to ask, well will I need immune suppression. So, to our surprise, when we mix undifferentiated embryonic stem cells with people's blood with a different tissue type, they don't react to them. Moreover, in that example of your blood mixed with my blood, if we drop undifferentiated embryonic stems cells into that test tube, those cells would stop your body from recognizing me and vice versa, me from recognizing you. Moreover, the differentiating cells including the OPCs that we're talking about here, are negative in those same aspects.

      Now, what's that all about? Well, you've got to go back to the source of the biology and spend a little bit of time talking about the immunology of embryo implantation because that process is no different than an allograft transplantation into a woman's uterus because the embryo, with respect to the mother, is an allograft. It has mother and father tissue antigens so the question arises why doesn't the pregnant woman immunologically reject that implanted embryo and they never do that and the reason is the blastomeres in the blastocyst, those are the cells from which embryonic stem cells are derived have learned how to create an immune tolerant or an immune protective region in the uterus that prevents mothers' T cells from recognizing and killing that implanting allograft and, lo and behold, the embryonic stem cell has retained that capability so there's something in the membrane of both the undifferentiated stem cell and the differentiating cells we make from them that prevents the T cell which recognizes its alloness from reacting to it so the T cells don't activate so that suggests that for all of these therapies, whether it's OPCs into the spinal cord, cardiomyocites into the heart, islets into the liver, whatever, we will not need high dose for life immune suppression. Now with the particular case of the oligodendrocyte spinal cord injury opportunity, there's a further safety factor because once the injury heals, you are once back into the protected site of the central nervous system which is an immune privileged site further reducing the likelihood of immune detection of these OPCs. Nevertheless because we want to test one variable at a time, in the clinical protocol we will cover the patients with low dose cyclosporin for about three months and then withdraw it by which time the lesion should be healed and there should be no egress of any immune cell into that spinal cord lesion.

      Now, that's sort of the near term biology? There is a second generation approach that we'll be announcing later this year which should completely eliminate the need for any immune suppression for any of these cells and that has to do with a way to immunologically tolerize you or me to any of the cells made from a particular stem cell line and here's how this works -- and this can only be done with embryonic stem cells because these are the only stem cells that are pluripotent, that you can make all cell types of the body from each of our lines so one of the cell types that we know how to make are immune cells and specifically these are dendritic cells and there's a certain kind of subset of a dendrit

      --
      Steven / Wired News
    3. Re:Bullshit by Maset · · Score: 1

      Thank you very much for that, it does seem then that this is quite a leap forward.

    4. Re:Bullshit by se-wired · · Score: 1

      Anytime. I'm happy to help.

      --
      Steven / Wired News