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    Stem Cell Therapy: Leading Edge Medicine Or 21st Century Alchemy?
    By Hank Campbell | April 17th 2013 12:19 PM | 7 comments | Print | E-mail | Track Comments
    About Hank

    I'm the founder of Science 2.0® and co-author of "Science Left Behind".

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    In 2013, stem cell therapy is touted as the future of medicine by proponents in Europe and Asia while scientists in America urge caution. Contrast that to a decade ago, when the concern was that American President George W. Bush was holding back progress because he limited federal funding for one form of stem cell research. In 2012, Governor Rick Perry of Texas not only believed in stem cell research, he declared that he wanted to make his state the home of American stem cell science.

    The stem cell issue is controversial again because Italy formally approved stem cell therapy in 32 terminally ill patients, the first time a government in the developed world has embraced it. Proponents want more and argue it should be available to all terminally ill patients while scientists, who cheered when celebrities like the late Christopher Reeve and former first lady Nancy Reagan talked about the potential for stem cells to save lives, are saying we need to be more conservative in our approach. 

    Stem cells have been victims of their own positive public relations machine.  Similar to gene therapy, where an abnormal gene is replaced by a normal one, stem cell therapy seeks to replace malignant cells with healthy ones. But to-date there have been no published studies showing stem cell therapy actually works, at least not the kind being sold to the public. Bone marrow transplants have been successful since the 1960s and that's stem cell therapy, argue proponents. It’s too risky, argue scientists. Like happened with gene therapy in the 1990s, a death attributed to an unproven treatment - even in a terminally ill patient - could set back legitimate research. The public remains confused by the difference between embryonic and human embryonic stem cells, adult stem cells and mesenchymal stem cells and induced pluripotent stem cells and the various protocols in pre-clinical studies. Such confusion is a call for action, not a signal to retreat.

    Following the decree by the Italian Health Ministry allowing terminally-ill patients (including children) already using the treatment to continue, scientists in Europe released a statement that these treatments are exploiting desperate parents and are nothing more than expensive placebos. It is not that they have been shown to be dangerous, it is that the effects are unknown because the stem cell 'cocktails' used are unknown and untested. The patients are part of an unregistered clinical trial outside European licensing criteria.  Elena Cattaneo from the University of Milan told Nature magazine, “It is alchemy.”

    Alchemy sought to find the scientific secret of a ‘Fountain of Youth’ and also to turn base metals, like lead, into gold. Its practitioners used scientific methods and were versed in chemistry and even medicine, giving alchemy an air of legitimacy. In that sense it was a proto-science and it certainly advanced those fields. Sir Isaac Newton, famous for his Three Laws of Motion, was intrigued by the promise of alchemy and may even have taken the job running England’s national mint to further his work in it. But they didn't experiment on desperate families and the secrets of transmutation remained closed even to Newton; current stem cell therapy success may be just as elusive. Like homeopathy, it could be more like a high-priced placebo than a clinical treatment.

    Still, as long as people are willing to buy a Fountain of Youth, someone else will sell it. In the Philippines, cosmetics salons are offering collagen stem cell therapy they claim will make skin look younger. Customers may find they purchased lead rather than gold because their ‘stem cell therapy’ is simply transferred fat with fluid removed. There is no evidence at all these fat stem cells can ever ‘self-renew’ just by being moved from the abdomen to the face.  


    You don't have to go to the Philippines, Sears will sell you a jar of stem cell therapy goop for $95. Go USA!

    Yet there is also real science being done and scientists worry it will be lumped in with cosmetic claims. Since 2008, when researchers made severely disabled mice walk again using human glial progenitor cells injected into rodent brains, the race has been on to get proof-of-concept for treatment in diseases like Parkinson's disease.

     Whether to embrace and license stem cell therapy, so that stem cells can be manufactured according to scientific standards and patients can have protection, or to invoke the precautionary principle and ban it altogether is the policy struggle that will soon confront us. It could be that the real breakthroughs in stem cell therapy will happen in corporate labs rather than academic ones, but in order for that to happen stem cell therapy needs to emerge from the shadows.

    *******

    Hank Campbell is the founder of Science 2.0 and co-author of Science Left Behind. Also follow on Facebook and Twitter, if that is your thing.

    Comments

    Weak article by someone with little knowledge of what is happening in the industry on the human side and on the veterinary side. Here's just a snippet. Incredible results are already taking place to name one example human wound care ie Osiris Grafix. On the vet side, its pretty obvious that stem cells work, and this clearly is showing a path forward for humans. It's my belief the FDA, a revolving door with the bigs, is going to fight the use of stem cells until the big players can figure out how to make as much money from it as possible. US Supreme Court cases such as the one currently under consideration regarding how a natural cell is patentable will lay the groundwork for the legal basis of the entire industry. Simple effective non patentable solutions will largely be ignored by the bigs as unprofitable. Allogenic stem cells will be the province of the bigs. However, the small will win too, such as Cytori's medical device for simple extraction of fat and reinjection of autologous adipose stem cells. The same with Tigenix and its autologous Carticel knee cartilage grown from your own stem cells which is already being reimbursed in Europe. Its really just a matter of time before vast swaths of the entire medical world are completely changed.

    Hank
    Weak article by someone with little knowledge of what is happening in the industry on the human side and on the veterinary side.
    You'll forgive us if we don't all wonder what you are selling. Stem cell therapy for dogs, I assume. In actuality, this article is the most positive you will find in science media. Most people would rather just call out the whole field due to the charlatans and don't see there is valuable research potential - which I noted.
    Its really just a matter of time before vast swaths of the entire medical world are completely changed.
    Maybe, but again there has to be evidence it works.  What do you call alternative medicine that is shown to work in double-blind clinic trials? Regular Medicine.
    I only hope that Hank doesn't cause loss loss of life or limb. I am serious. Evidence abounds if you know where to look. Hank certainly isn't good at finding evidence. He can't even figure out where I'm coming from, believing me to be a proponent of stem cells for dogs rather than what is true. Like everyone, I am a potential patient who might receive stem cell treatment in the future. I'm also an investor. I scour the news and web daily for stem cell articles, webcasts, and anything on the subject I can find. I ran across his horrific article and had to at least help set the record straight. What follows is a small sampling of evidence.

    Pluristem's PLX stem cells have received Orphan Drug Status from the FDA for two diseases, aplastic anemia and Buerger's Disease, a severe peripheral artery disease. Pluristem placental stem cells has saved lives of people with GVHD on a compassionate use basis. So instead of dying you get to live.

    Tigenix has approved Carticel in Europe. They take your own stem cells from your knee grow them in a lab to the size needed to replace a cartilage defect and then transplant them. Its approved and its being reimbursed. So instead of missing cartilage, you can replace the cartilage. Tigenix is expected to release results this month on allogenic stem cell treatment of Rheumatoid Arthritis that has resisted at least two biologics.

    Osiris has Prochymal, which is being evaluated in Phase 3 clinical trials for several indications, including acute graft versus host disease (GvHD) and also Crohn's disease, and is designated by the FDA as both an Orphan Drug and Fast Track product.

    Osiris also has Grafix, an FDA approved wound care product, that has a 70% closure at nine weeks of wounds that haven't closed. So instead of amputation you get to keep your limbs. Something must be going right, their revenues are increasing 35% quarter over quarter.

    Anyone can look up National Geographic's presentation of the skin gun, an amazing device that uses the victims own skin stems cells to heal burns on other parts of their body. In the case highlighted, it completely healed a man with second degree burns in four days. Treatment on Friday, healed by Monday. It will boggle your mind.

    Cytori recently received a $100 million dollar contract from the US government to develop burn treatment using stem cells. They already have the evidence.

    Evidence, evidence, evidence! The human ability to create a delusion never seems to amaze me. You would think Hank was affiliated with a major pharmaceutical company with a vested interest in maintaining the status quo with his nauseating remarks. In regards to vet medicine, there's enough anecdotal evidence of lame horses that previously would be put down recovering with stem cell treatment and of vets trying stem cells on their own dogs to see if it works before offering it to the public to know that it works. A true scientific mind accepts that evidence comes in many forms not just a double blinded study. Have you ever learned something that hasn't been proven in a double blinded study? Of course! For instance, we don't need a double blinded study to know Hank just doesn't know what he's talking about when it comes to this subject matter.

    Hank
    You're confusing stem cell research with stem cell therapy and then declaring I don't know what I am talking about.  In the article I note that the public has been confused - and greedy companies are exploiting that - and this is a good example. Like you, I hope stem cells are able to help many people but I hope you use your investment dollars wisely.
    "I ran across his horrific article and had to at least help set the record straight."

    Well, you didn't set the record straight. The truth is, only one stem cell therapy procedure has been approved by the FDA, and that's a treatment for acute myeloid leukemia. Everything else you mentioned is either in development or hasn't yet received FDA approval. And indeed, a lot of scientists do consider stem cell therapy -- in its current state -- to be alchemy. The technique holds much promise, but we're a long way from declaring victory in regenerative medicine. It's very much unclear from your post that you actually understand that.

    "A true scientific mind accepts that evidence comes in many forms not just a double blinded study."

    It's funny that you claim that Hank doesn't know what he's talking about, yet you drop that doozie. That line of reasoning is usually used by alternative medicine quacks.

    When it comes to medical treatments, the only acceptable evidence is a randomized clinical trial, preferably double blinded.

    Wow!!! Its so much easier to try to argue in generalities rather than point to specifics. It allows you to avoid even having a rational argument or for goodness sake doing even the slightest research into the subject. Its an interesting technique, but falls flat on its face when exposed. Its too easy to discredit your words. Its impossible for you to acknowledge you aren't an authority on this subject. You can't tell us how many hours you've spent on the subject, because its so few. It may be fortunate that you chose to engage me, as doing so reveals your inadequacies in knowledge and some deeper personality flaws. This will be useful for the reader and for you. The more you engage me, the more your flaws will be exposed. This can be a moment in your life where you can look inside yourself and begin to change for the better. It can be a positive for you. I myself appreciate the exercise in dealing with someone who is delusional and/or irrational. Finding calm in such situations is always a challenge, and this is a good exercise for me. Thanks for that challenge. This will be the last of it for me.