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The Shady Side of Embryonic Stem Cell Therapy

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    The Shady Side of Embryonic Stem Cell Therapy

    This is a very good article by Stephen Barrett, M.D. about "embryonic stem cell therapies" that various clinics and doctors are offering around the world.

    http://www.quackwatch.org/06Research.../stemcell.html

    The Shady Side of Embryonic Stem Cell Therapy


    Stephen Barrett, M.D.


    Stem cell therapy is certainly a promising area for research. Stem cells have the ability to give rise to many specialized cells in an organism. Certain types of stem cells are already used to restore blood-forming and immune system function after high-dose chemotherapy for some types of cancer, and several other restorative uses have been demonstrated. The broadest potential application is the generation of cells and tissues that could be used to repair or replace damaged organs. If scientists can learn how to control stem cell conversion into new, functionally mature cells, doctors might be able to cure many diseases for which therapy is currently inadequate [1,2]. However, the claims made by commercial promoters go way beyond what is likely and should be regarded with extreme skepticism. The main commercial sources appear to be Embryonic Tissues Center in the Ukraine, and Medra, Inc., in the Dominican Republic....
    Embryonic Tissue Center (EmCell). Barrett pointed out that EmCell did not answer many of the questions and concluded that "We have not found any data that suggests that the methodology used by EmCelll is scientifically reasonable, or that it is helping ALS patients..." It points out that EmCell suggested that "the number of cells does not matter since the cells will divide once they are in the body" and that "these stem cells DO NOT draw the attention of the immune system...", saying that both of these are red glags that suggest that Emcell does not understand how stem cells work and does not comport with known information about immune reaction to stem cell transplants.

    Embryonic stem cell transplants. Please note that they are probably referring fetal stem cell transplants and not embyronic stem cell transplants derived from blastocysts. The article reviews Dr. William C. Rader, M.D. of Medra, the "chief American commercializer of embryonic stem cell research" in Malibu, California. For "$25,000 (wired in advance), Rader will arrange for treatment at his Dominican Republic clinic." It points out Rader also claims that "his fetal stem cell treatment is not antigenic and has no side effects." Rader also claims that the treatment is beneficial in a very large list of diseases ranging from ALS and Autism to Spinal Cord injury and Stroke.

    Cord Blood Banking. The article describes the Cord Blood Registry headquartered in San Bruno, California which charges $1,600 for processing and $100 per year for storage. It also mentions Cyrobanks International in Alamonte Springs, Florida. Barrett points out that the advertising by these organizations contradict the American Academy of Pediatrics position that there is no strong evidence supporting routine cord blood banking for future use by the infant.

    The Quackwatch Home Page has many other articles about nutrition supplements and other treatments for cancer and the like:

    In summary, Stephen Barrett points out several red flags that people should pay attention to when evaluating alternative therapies. Among these are claims that the therapy cures everything, the suggestion that it is completely safe, and the absence of peer-reviewed evidence supporting the claims (even though the service has been provided for many years). The article contains links to many excellent resources concerning stem cell therapy.

    Wise.

    P.S. Originally, I had posted this article in full but, in keeping with the new copyright policy of the site, I have excerpted it below and people can read the full article at the site above.

    [This message was edited by Wise Young on 01-12-04 at 11:40 AM.]

    #2
    Dr. Young:

    It was nice to communicate with you in the Chat Room and thank you for addressing the issue of "The Shady Side of Embryonic Stem Cell Therapy."

    PN
    The test of success is not what you do when you are on top. Success is how high you bounce when you hit the bottom
    --General George Patton

    Complex problems need to be solved collectively.
    ––Paul Nussbaum
    usc87.blogspot.com

    Comment


      #3
      Paul, you are of course very welcome. This is a very sober article and one that sets forth a number of criteria for judging the claims of these organizations.

      People should be suspicious when an unknown group that has no track record in doing stem cell research suddenly makes claims of cures beyond what anybody has been able to achieve.

      Wise.

      [This message was edited by Wise Young on 12-19-03 at 02:19 PM.]

      Comment


        #4
        Fetal blood cells carry some antigens, notably the ABO groups and the one which is the most trouble, Rh. If they didn't we wouldn't need Rhogam (Rh immunoglobulin)

        C5/6 incomplete, injured Aug. 2000
        Blog:
        Does This Wheelchair Make My Ass Look Fat?

        Comment


          #5
          betheny,

          When umbilical cord blood is used for therapy, one tries to match as much of the antigens (including ABO and Rh, as well as HLA antigens). It is not difficult to get ABO and Rh matching. That is what is done everyday in blood transfusion. Getting HLA (human leukocyte antigen) matching is much more difficult.

          HLA are histocompatability antigens and fall into three classes: HLA-A (>25 forms), HLA-B (>50 forms), and HLA-DR (>15 forms). If people want to read more about it, the National Marrow Donor Program has a good web site on the subject.

          Wise.

          Comment


            #6
            Dr. Wise,

            This is very sad. Yet expected in a way.
            I almost feel terminally ill individuals look
            for those reputed as quacks.

            The string of hope is very strong..and when
            the reputable sources have no avenues..it is
            relatively normal to explore other routes.

            All the news items about stem cells have many
            interested in treatments now..before their time runs out. I guess it would be ideal to
            leave it out of the press until something real is available.

            On the 9 of March 1911 the New York Times
            ran the following article:

            The Rockefeller Institute in this city believes it's search for a cure for infantile
            paralysis is about to be rewarded. Within six
            months, according to Dr. Simon Flexner, definite anouncement of a specific remedy may be expected.

            "We have already discovered how to prevent the disease," says Dr. Flexner in a statement
            published here today. "and the achievement of
            a cure, I may conservatively say, is not now far distant."

            Embellished press releases is what gives the quacks their power, yet are necessary to get
            funding...double whammy as usual.

            <"();::::::::::;~
            Life isn't about getting thru the storm but learning to dance in the rain.

            Comment


              #7
              Lindox,

              What you are referring to are breathless press announcements that are not primarily meant for people with spinal cord injury and disabilities. They are really aimed at venture capitalists and potential investors.

              It is the direct advertisements to people with disabilities, quacks who are trying to convince people to pay money for their unproven treatments that is a problem.

              Wise.

              Comment


                #8
                Rader was a client of mine on and off for a number of years. Been into their West Los Angeles offices when the weight loss thing was in full swing, and later in the Malibu offices.

                In tinsle town, acadamy award winning performances abound both on and off the set. So perhaps my impression of genuine concern to help folks with innovative ideas was based upon a series of well rehearsed performances.

                admittedly intentions do not justify means....and individual motivations of the afflicted can lead to poor decisions. I suppose the upside is that nobody has died from these experimental procedures, which probably won't damage future prospects of human trials with cell therapy - this time. If somebody does die as a result of these "rogue" acts, it could seriously impede future trials - and we don't need that.

                However this does illustrate a prevelent problem in our current system: the gap between global and animal research vs clinical application of new therapies in the US. We are simply not leading the race on clinical cell therapy and people here know it. So why re-invent the wheel when it has been done? Let's just build upon it and allow patients to benefit. After all, if we can justify a multi-billion dollar war to "protect our way of life", we should be able to loosen the noose a little on health care research.

                As we know, in the absence of an approved procedure, people in certian situations will justify taking a personal risk that others may determine to be foolhardy. It's a personal decision - often driven by pain and frustration. Without a santioned option, these "motivated" people will seek unsantioned options, exposing them to potentially dangerous situations.

                I believe we need an environment(process) that will let individuals with certian life altering afflictions (cancer, SCI, etc) undertake experimental procedures - under the right conditions. ie substantially less stringent than the "normal" FDA approval process, yet with enough common sense safeguards to prevent overtly dangerous procedures.

                For instance, if overseas human or domestic animal trials have been successful, a methodology to expedite human clinical testing for individuals that are willing to accept the associated risks of a new therapy.

                In short, we need more open pre-trial critera for clinical research, specifically for people with major afflictions.

                The upside is too great to ignore - better documentation and understanding of overseas based techniques, reduced R&D costs, faster turnaround from lab to clinic, access to lots of willing patients, and most importantly - a sanctioned outlet for individuals with major afflictions that is sane.

                Until that happens, we are at risk of people "jumping the gun" and trying things in a totally uncontrolled manner, with consequences that could damage the future of a viable therapy.

                As a motivation for govt. to implement such a system, perhaps if we build a database of individuals with major afflictions, and use their collective barganing power to gain attention to implement qualified pre-trial testing, we might be able to effect a far reaching process that will ultimately benefit both science and citizens.

                I just happen to already have an IT infrastructure (database etc) ready to go... just needs names and some input for the bill (mostly liability restrictions) to be introduced... anybody interested?

                sorry if I may have hijacked the topic, but it's seemed relevent at the time.

                rvr
                rob

                Comment


                  #9
                  rvr,
                  Your post has to be one of the best I've
                  read.

                  I would think your database would become
                  overfull if presented to the various groups
                  involved.

                  It is very hard to discern if the two doctors
                  involved are "rogues" or "quacks".

                  The ALS watch people seem to be the ones most
                  involved..yet on EmCells website..no mention
                  of ALS that I could find.

                  Best of luck with your database project..
                  The very best of luck.

                  <"();::::::::::;~
                  Life isn't about getting thru the storm but learning to dance in the rain.

                  Comment


                    #10
                    Dr. Young-
                    For starters you are a true pioneer! Without you SCI research would NEVER be where it is today. You have been of incalcuable help and support. Thank you for each and every letter you've written me and all else back. At this rate you must have serious doubts about therapies to restore substantial function in the next several years. Being a man of science, the science hasn't translated out of the lab and into concrete results. Please feel free to disprove me at any time. You cannot rationally believe that paraplegics' who've been injured for years will walk again. With stem cell therapy approved for study in New Jersey, how long do you think it would take to get concrete results if the science actually worked?

                    sherman brayton
                    sherman brayton

                    Comment


                      #11
                      sherman,

                      There is a place for several strategies in the cure game. One approach is to abandon everything that may take a long time and keep throwing the long passes that may get us quicker to the other end of the field but have a high risk of failure. Another approach is to stick to the running game and get to first down every time. I believe that we should use both the passing and running game. In many ways, stem cells research is the running game while OEG transplantation is a Hail Mary pass.

                      In my opinion, OEG transplants are producing a modest return of function and they will produce more return when combined with other therapies. There are three other therapies that are likely to be in clinical trial within a year or two: chondroitinase, GDNF, and rollipram (phosphodiesterase 4 inhibitor). Several laboratories have reported that chondroitinase is useful in spinal cord injury but there are serious questions about side-effects of giving a bacterial enzyme to the human spinal cord and it is not yet clear that the treatment is effective in chronic spinal cord injury. Those studies are going on right now. GDNF is believed to be both neuroprotective and regenerative. The drug is already in clinical trial and there are serious efforts underway to see whether or not GDNF will be synergistic with cell transplants. By the way, OEG cells secrete GDNF and part of the beneficial effects of OEG cells may be related to the GDNF that they produce. Finally, Mary Bunge and her colleagues at the Miami Project recently reported that dibutaryl cAMP and rollipram treatment combined with Schwann cell transplants regenerate the spinal cord and produce functional recovery in the rat contusion model. This is very exciting and they are working hard there to try to move this towards clinical trial. These are only three of the possibilities that are coming up in 2004.

                      There is a lot of work to do and unfortunately not enough money to move it as quickly as it can go. Much of the time is spent raising money for experiments and clinical trials. One of the things that has bothered me for a long time is that many scientists are being forced to spend all their time raising money and writing grants. It is such a waste of their time and energy. They would much rather be working in their laboratories. But, the problem is that there is currently nobody else who is doing it, except for a few places such as the Miami Project, CRPF, and a few small foundations.

                      Shortly after he was injured, Christopher Reeve understood that the first step is hope. Without hope, there can be no progress. There will be no funding, no people, no effort, nothing will happen. Now, hope is in the hearts and minds of the scientists. More and more clinicians are backing off their pessimistic statements. Many drug companies are beginning to look at the possibility of investing in spinal cord injury research. There were no chronic spinal cord injury clinical trials going on in 1995 when Christopher was injured. Now, there are about half a dozen clinical trial around the world. We must continue to put the pressure on. It will happen and more rapidly than we think.

                      Finally, I want to emphasize that the spinal cord injury community must become more altruistic and take a longer view. Nobody doubts that a cure is possible. We must find the cure not only for the people here today but for our children.

                      Wise.

                      Comment


                        #12
                        Interesting analogy although I'm not sure I would agree that OEGs are a "Hail Mary". If they are producing modest return of function and will likely improve with more components, I'd call this more of a "Running Game". At this point I would probably consider a stem cell therapy more of a "Hail Mary".

                        Either way, the more approaches and "attacks" we have on SCI, the better the odds of success. I'm sure we can all agree on that.
                        "Oh yeah life goes on
                        Long after the thrill of livin is gone"

                        John Cougar Mellencamp

                        Comment


                          #13
                          mike99,

                          When I suggested that OEG's represent a passing game, I was thinking about what Dr. Huang did when he first implanted OEG cells into patients. Two years ago, it was a "Hail, Mary" pass with little evidence that would suggest that it would succeed. Fortunately, the pass connected but it was short of the goal line. We now have to make sure that the ball does cross the goal line. We are at a very delicate point in the OEG field. Many clinicians are still skeptical about the efficacy of OEG's but at least they are beginning to pay attention.

                          I believe that NIH and other organizations are taking a running game strategy towards stem cell therapies. Most believe that there is long yardage that still must be covered before the attempt is made to take the ball across the goal line. Now, if somebody took embryonic stem cells and plunked them into a human being now, that would be a "Hail Mary".

                          The American football analogy is actually very useful because it illustrates some of the limits of the cure game. Like football, we don't have an infinite number of attempts at the goal. There are resources for only 2-3 attempts. While there are many people who believe that it is just a matter of "trying" out a therapy, we must consider the risks of taking a therapy to clinical trial when we have little idea of how and why the therapies work. When the therapy fails or has limited effects, we must go back to the drawing board and figure out how to make it better. We can only do that a few times before time and money runs out.

                          The OEG studies done by Dr. Huang have convinced me there is a rapid but modest improvement of function. His work has raised many important questions. First, what is the mechanism of the improvement. It is not currently well-explained by any known phenomenon, except for sprouting of surviving or regenerated axons in the spinal cord. Second, should people be immunosuppressed to prevent rejection? We know that OEG heterografts are rejected in rats within 3-4 weeks. It may take longer in humans but I suspect that it probably happens in humans as well. Third, will OEG's be more effective if it is combined with other therapies? We have been working hard in the laboratory to find answers to these questions.

                          Wise.

                          Comment


                            #14
                            Originally posted by Wise Young:


                            Finally, I want to emphasize that the spinal cord injury community must become more altruistic and take a longer view. Nobody doubts that a cure is possible. We must find the cure not only for the people here today but for our children.

                            Wise.
                            I couldn't agree more.

                            www.misportsunlimited.com

                            Comment


                              #15
                              bump

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