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Thread: More interesting excerpts from “Stem Cell Now”

  1. #1
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    Question More interesting excerpts from “Stem Cell Now”

    http://www.npr.org/templates/story/s...toryId=5204335


    The truth of the matter is, we've got a goodly distance to go before regenerative medicine -- a catchall term for stem cell therapy -- will help large numbers of patients. It is very possible that many diseases will have to wait for cures from other quarters of medicine. Before any medical treatment (including cell and tissue transplants) is made available through hospitals or clinics, it must first be tested in humans through tightly regulated phases of clinical trials. The first phase determines safety and side effects in a few dozen subjects; the second phase tests efficacy in hundreds of patients; the third and subsequent phases try to prove statistical significance and confirm its effects in many hundreds or thousands of patients. The U.S. Food and Drug Administration (FDA) evaluates the data, and if the results pass muster, the product is approved for sale and moves to the market. Developing a new therapy goes slowly and is terribly expensive -- discovering, testing, and manufacturing one new drug can take between 10 and 15 years and cost nearly a billion dollars.

    A hypothetical timeline of a new treatment for skin transplants might look like this:

    • Basic Research: In 2006, a source of powerful adult stem cells is discovered beneath human skin. The rare cells are fingerprinted by genetic markers, and the markers are used to isolate the cells from the body and culture them in the lab. Over the next two years, technology is developed to grow the cells in quantity and used to change them into a variety of skin cell types.

    • Preclinical Research: Different lines of skin stem cells and their progenitors are transplanted into the injured skin of a transgenic mouse with no immune system (to prevent rejection of the human cells). Over time the transplants are observed. One line works: the cells survive, go to the site of the injury, integrate into the skin, and heal the wound. Other kinds of animals are similarly tested. The tests take three years to complete.

    • Clinical Research: The encouraging results in animals prompt tests in humans. In patients with severe burns, the patient's own skin stem cells are cultured, multiplied and then transplanted at the wound site. The cells improve blood flow, promote healing, and reduce scarring. Using adult stem cells is not the only way to approach the problem. An hESC line using nuclear transfer might also produce the skin stem cell in question. The technologies are further developed by companies, tested in more humans, and manufactured for use for burn victims. In 2014, the FDA approves the first cell therapy for use in clinics.
    More on link above.
    Last edited by Leif; 03-11-2006 at 10:46 AM.

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    Banned Faye's Avatar
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    On ESCR.....

    Stem Cell Now points to some draw backs to Adult stem cell Research as Leif's excerpt deals with too.

    Here some more on ASCR vs ESCR:

    Customized treatments that can't rely on economies of scale are likely to be very expensive. For an adult stem cell regimen, the tissue in which the stem cells reside must be biopsied -- perhaps more than once -- surgeries that can put elderly patients at risk. For any cell therapy the methods for isolating, growing, and expanding the cultures must be perfected -- complications not yet perfected for adult stem cells. The procedures must produce millions upon millions of homogenous, long-lived cells that exhibit stemness. Like any transplant, the cells must be free of contamination with unwanted viral, bacterial, or chemical agents.

    To avoid "homegrown" protocols and to ensure quality, companies and hospitals will need to standardize laboratory, manufacturing, and clinical practices. Health professionals will need training to provide proper informed consent and oversight of the procedures. Some researchers assert that for each patient, between 10 and 20 technicians will need to work full-time in specialized laboratories. The costs for such individualized treatments, they say, would be astronomical.

    A different strategy may reduce the cost. Rather than developing a custom stem cell line for each person, nationwide banks of several thousand hESC lines could be developed. The banks would use a test called HLA (histocompatibility antigens) typing to match donor and recipient genes, minimizing tissue rejection. The closer the HLA match (either from family members or from outside donors), the less the chance that rejection will be a problem. A similar list of donors already exists. Over 6.5 million individuals have already been HLA-typed for bone marrow registries.
    Repairing Nerves
    The "before" videotape shows a rat with a recently damaged spinal cord. Staggering inside a circular Plexiglas container, the animal drags its hindquarters along the runway, its tail trailing limply behind. The next segment shows the same rat after an injection of oligodendrocytes made from a line of embryonic stem cells. It sniffs the air and stands on its rear legs. Dropping down, it takes a lap around the cage with only a slight suggestion of a limp -- once disabled, now cured. The revived rat is compelling visual evidence that Professor Hans Kierstead uses to wow audiences of scientists, patients, and news reporters.

    The University of Irvine neuroscientist is backed by the Christopher Reeve Foundation and the stem cell company Geron. His recently published research on rats has caused a stir among patient activists and physicians who are impatient for human testing to begin. He takes embryonic stem cells and differentiates them into pure colonies of oligodendrocytes, the neural cells that form the conductive material myelin. The cells are then injected seven days after the injury, and the rats began to walk properly within two months of the treatment. Timing is crucial: when Keirstead waits until 10 months after the injury, motor movements do not return. The rat's trauma doesn't sever the nerves -- leaving the basic wiring essentially intact -- and it's not clear how effective the procedure will be for injuries involving severed nerves or scar tissue. Geron hopes to clinically test the safety of their therapy in as early as 2006, during the routine surgery that follows an accident. Repairing damaged human nerves can be a major medical victory -- the success would ripple far beyond spinal injury to demyelinating diseases, such as multiple sclerosis.

    Chapter 3 detailed the chain of developmental events that lead to the most complex network of cells in the body, the nervous system. When it comes to understanding how nerve cells come to be, Anders Bjorklund, professor and chief of the Wallenberg Neuroscience Center at Lund University, Sweden, says that "compared to our understanding of the blood stem cell system, we are at least a couple of decades behind." Bjorklund, with support from the Michael J. Fox Foundation, pursues clinical research in Parkinson's disease, where loss of cells that produce dopamine causes neurons to fire out of control; this results in loss of motor movements.

    At this writing, no human clinical trials are using stem cells for Parkinson's, but there is a history of treating Parkinson's patients using neural cells from aborted fetal tissue. Bjorklund's ground breaking work in the late 1980s transplanted six-to eight-week-old neural fetal cells into the brains of humans and proved that cell therapy could actually work. In the majority of patients the injections improved motor function. Follow-up studies have been less encouraging. A clinical trial in 1999 at Columbia University and the University of Colorado had mixed results, helping younger patients but offering no benefit to patients over 60. In 2001, the same physicians did a follow-up study, but this time tremors in 6 out of 20 patients receiving fetal cells became worse. The results worried many who feared that cell therapy could be more damaging than therapeutic, especially when treating brain disease. As a result, preclinical work with stem cells is moving slowly through animal testing. Chapter 6 describes how embryonic stem cell therapy can improve Parkinson's-like symptoms in rodents and monkeys.

    http://www.npr.org/templates/story/s...toryId=5204335

    "There’s far too much unthinking respect given to authority,” Molly Ivins explained; “What you need is sustained outrage.”
    Kerr, Keirstead, McDonald, Stice and Jun Yan courageously work on ESCR to Cure SCI.

    Divisiveness comes from not following Christopher Reeve's ESCR lead.
    Young does ASCR.
    [I]I do not tear down CRPA, I ONLY make peopl

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    My excerpt was aboth the time-frames for a cure... 2014?
    Last edited by Leif; 03-12-2006 at 03:33 PM.

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    Banned Faye's Avatar
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    Quote Originally Posted by Leif
    My excerpt was aboth the time-frames for a cure... 2014?
    ESC based therapies may be faster because:

    1. They are less expensive,......rather than developing a custom stem cell line for each person, nationwide banks of several thousand hESC lines could be developed.

    2. They may be done overseas where things can be speeded up.

    "There’s far too much unthinking respect given to authority,” Molly Ivins explained; “What you need is sustained outrage.”
    Kerr, Keirstead, McDonald, Stice and Jun Yan courageously work on ESCR to Cure SCI.

    Divisiveness comes from not following Christopher Reeve's ESCR lead.
    Young does ASCR.
    [I]I do not tear down CRPA, I ONLY make peopl

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    Quote Originally Posted by wcrabtex
    I would be pretty happy with 2014. Sure beats never.

    wcr
    Right WCR. - 2014 or one or two decades away as some others says Source. What are they actually telling us here? They tell us they believe there will be a “cure” but can’t say exactly when? The good thing is that they believe in a cure. And then "when" becomes a more hypothetical question. Thereby since they say the cure will be here it is for us to push for having it here ASAP. How come the cure is not here when most of the researchers believe in a cure? I think that is the question we should raise. I also think the answer to this question is telling us where the bottlenecks are. And it is those bottlenecks we have to remove. Leif
    Last edited by Leif; 03-13-2006 at 10:29 AM.

  6. #6
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    Quote Originally Posted by Leif
    How come the cure is not here when most of the researchers believe in a cure? I think that is the question we should raise.
    Exactly!
    That also has been Bigbob's signature for the past year.


    Quote Originally Posted by Leif
    I also think the answer to this question is telling us where the bottlenecks are. And it is those bottlenecks we have to remove. Leif
    Again, right on!

    Even if ESCR is not directly needed for SCI repair ( though I think it actually is needed for SCI repair), we need to learn as much as possible from ESCR to know more about the regenerative potential of adult stem cells too.

    I still think that is the major bottleneck, in addition to the cost and time of FDA approval of cellular treatments.

    "There’s far too much unthinking respect given to authority,” Molly Ivins explained; “What you need is sustained outrage.”
    Kerr, Keirstead, McDonald, Stice and Jun Yan courageously work on ESCR to Cure SCI.

    Divisiveness comes from not following Christopher Reeve's ESCR lead.
    Young does ASCR.
    [I]I do not tear down CRPA, I ONLY make peopl

  7. #7
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    Right. ESCR is important as researchers tell us Source. I also believe the question as you are mentioning can be further broken down to; politics, funding, public awareness, clinical trials, international collaboration and collaboration and clear goals from the SCI organisations. It is a huge task to put all this together, but who have said we are afraid of a little work and huge tasks?

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    Senior Member Schmeky's Avatar
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    Quote Originally Posted by Leif
    My excerpt was aboth the time-frames for a cure... 2014?
    This sounds correct. Of course, the availability of effective therapies for chronics is the missing link.

    2014 is doable if we the had the therapy today.

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    Schmeky. I have a feeling there is a lot of stuff going on in the labs around the world (i.e. this Link); it’s just to collect and streamline (a little bit more research) all the data and move it into humans.

  10. #10
    Senior Member Schmeky's Avatar
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    Quote Originally Posted by Leif
    Schmeky. I have a feeling there is a lot of stuff going on in the labs around the world (i.e. this Link); it’s just to collect and streamline (a little bit more research) all the data and move it into humans.
    We all hope so.

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