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Scrutinizing a Stem Cell Trial 54

Posted by ScuttleMonkey from the under-the-microscope dept.
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."
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Scrutinizing a Stem Cell Trial More

Scrutinizing a Stem Cell Trial

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  • Rats can walk! (Score:4, Informative)

    by Eightyford ( 893696 ) on Wednesday March 29, 2006 @03:45PM (#15020066) Homepage
    In related news, stem cell transplants can repair injured spinal cords in rats! [monstersandcritics.com]

  • Testing on bums (Score:4, Interesting)

    by Eightyford ( 893696 ) on Wednesday March 29, 2006 @03:53PM (#15020119) Homepage
    I wonder where medical science would be if society allowed more testing on homeless people? [imdb.com] (not that I condone that, of course)

  • Summary (Score:3, Insightful)

    by Otter ( 3800 ) on Wednesday March 29, 2006 @04:01PM (#15020179) Journal
    Summary: This study had exactly the same oversight that every Phase I trial in the US has.

  • What does it say about our society... (Score:4, Insightful)

    by tverbeek ( 457094 ) on Wednesday March 29, 2006 @04:03PM (#15020205) Homepage
    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"?
  • What Ocomes around, Ogoes around.

    Will posting this hurt my excellent Okarma?

  • When to believe (Score:3, Insightful)

    by 1984 ( 56406 ) on Wednesday March 29, 2006 @04:10PM (#15020262)
    "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.
    • 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.
  • Why in the world do we need trials? Aren't they all guilty?
    • 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).
  • 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 ca

  • Good. (Score:3, Interesting)

    by posterlogo ( 943853 ) on Wednesday March 29, 2006 @04:48PM (#15020586)
    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.

    • Re:Good. (Score:3, Insightful)

      by MrFlibbs ( 945469 )
      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?

      • Re:Good. (Score:3, Informative)

        by posterlogo ( 943853 )
        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 furth
    • 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 o

  • 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.

    • 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?

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

        Like one [webmd.com]? It's not perfect, as the article points out, but it's working for some people, which seems to satisfy your criteria.
        • Unfortunately, that's a big misconception. Dr. Carlos Lima transplants the nasal mucosa, not stem cells.
          • "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.

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

              I have also written [wired.com] 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

  • 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.
  • 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
    • 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 "chemoatt

    • 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 happe

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