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Stanford Medicine

Cardiovascular Medicine, Stem Cells

The cruelty of fraudulent stem cell therapy

iStock_quackdoc.jpgUPDATE 01-30-10: In writing about what seems to be a clear case of medical abuse I did not note that there are legitimate scientists who continue to investigate the use of bone marrow cells as a vehicle for heart repair. My apologies to them. However, these therapies are still in the research stage and patients should only get them as part of a controlled clinical trial. The problem in differentiating research that is legitimate from that which isn’t only highlights the need for a certification system for stem cell treatments.

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When someone e-mails the Stanford Institute for Stem Cell Biology and Regenerative Medicine, the note comes to me. So I get to see a lot of heartbreaking pleas for help from patients or family members. Sadly, although a few stem cell therapies (such as bone marrow transplantation) are available now and many are getting closer, most stem cell treatments – the miracle cures for multiple sclerosis, paralysis, Alzheimer’s disease, heart failure and many other conditions – remain in the future.

This morning I got a plea not for treatment, but for justice. The writer’s mother had been seen in Florida at a self-described stem cell clinic for a heart condition. The mother had been through multiple open heart surgeries and valve replacements. She had been in the hospital as recently as November, and was still so frail she could hardly walk herself to the restroom. Nonetheless, the clinic convinced her that they could treat her for $65,000, and in January she was taken to an “ill-equipped and poorly staffed” hospital in the Dominican Republic. The writer reports that his mother was dead within two hours of the treatment.

It’s hard to tell from the note, but most likely the stem cell “therapy” was an infusion of cells that may have come from bone marrow or other tissue. There used to be hope among some scientists that stem cells from bone marrow could colonize and repair heart tissue, but a few years ago Irving Weissman, MD (the director of Stanford Institute for Stem Cell Biology and Regenerative Medicine) and Robert Robbins, MD (the director of the Stanford Cardiovascular Institute) proved that this was not true. There are some promising studies going on at Stanford and elsewhere looking at the use of cardiac-specific stem cells to repair the heart, but these are not yet clinical treatments, and no responsible scientist now thinks that you can throw just any old stem cell into the heart and it will make anything better.

That hasn’t stopped companies around the world from claiming that they treat all sorts of disease with stem cells, for the right price. These companies are represented by doctors or nurses here, but the treatments are usually done overseas to avoid scrutiny by US authorities. Weissman is currently president of the International Society for Stem Cell Research (ISSCR), and one of his priorities is to establish a system that will review stem cell treatments so that patients and doctors can find out which are scientifically valid. Until that becomes a reality, however, desperate and vulnerable people are dealt another round of heartache, and the truly wonderful promise of stem cell therapy may be tarnished by quacks.

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6 Responses to “ The cruelty of fraudulent stem cell therapy ”

  1. Amit Patel Says:

    It is very unfortunate that people have to find out the hard way about questionable and unproven therapies. However, bone marrow based therapies for the heart are in Phase 2 trials showing promise. They are still considered experimental but stating that they do not work is not founded in any science – basic or clinical. The sanctioned trials need to continue along with the newer generation of cells. There are a number of national or international trials that are sanctioned and being performed at a standard that is scientifically valid. However, the number of renegade clinics that prey on people’s dispair continues to grow.

  2. Christopher Vaughan Says:

    I said that there used to be hope among some scientists that bone marrow cells could be used to repair heart tissue, but you are right that there are many scientists who still have that hope. And it may be that there is something in bone marrow besides the stem cells that promotes cardiomyocyte growth, or there may be a bone marrow stem cell that hasn’t been studied yet that that helps heal the heart indirectly. The Stanford studies were the most carefully done studies using the most promising population of purified bone marrow stem cells. Some researchers are using different populations of cells or modifying bone marrow cells. So you are right that eventually something related to bone marrow might be useful in heart therapy. But phase 2 trials are the first small trials dealing with efficacy. Time will tell. In the meantime, only people enrolled in official clinical trials should be treated using these technologies.

  3. Lisa Kamen Says:

    The International Society for Stem Cell Research (ISSCR) is very concerned that stem cell therapies are being sold around the world before they have been proven safe and effective. Stem cell therapies are nearly all new and experimental. In these early stages, they may not work, and there may be downsides. The ISSCR created the Patient Handbook on Stem Cell Therapies (Dec. 2008) to help individuals understand what to look out for before considering a stem cell therapy, answer some of your questions on stem cells and stem cell therapies and give you the resources you and your doctor need to make the best decisions possible for treatment. http://isscr.org/clinical_trans/pdfs/ISSCRPatientHandbook.pdf

  4. David Sandler Says:

    Thank you Dr Patel. I have followed your work at the Univ of Pittsburgh for years. I know you are the investigator for some trials in the US and have recently published promising results. I commend you for your work to help those of us with cardiomyopathy.

  5. Don Margolis Says:

    The Vaughn article is so full of misleading statements, one can only guess as to the reason behind it.

    (1) The implication is that ALL stem cell centers are packed with charlatan renegades. That is why the Repair Stem Cell Institute was formed: to approve centers where no-option patients could find an honest option rather than suffer and die at home under a no-cures-allowed system.

    (2) Dr. Patel’s polite response notwithstanding, the so-called Weissman Robbins “proof” is a long disproven myth, only maintained by controlled medical journals which extol the future of useless embryonic stem cells and, starting in 2004, deny peer-reviewed articles which prove over and over again how well adult stem cells work on heart disease. But our doctors are not allowed to read about this in the land of the free.

    (3) Mr.Vaughn’s strange science chooses to ignore thousands of improved lives due to stem cells and then jumps all over one isolated incident as proof they don’t work.

    (4) Perhaps he can explain to your audience just how hundreds AND HUNDREDS of no-option heart patients have improved in USA clinical trials–trials which are years behind what is going on overseas. Does he think we are ALL foolish enough to believe his nonsense when tens of millions of (non taxpayer) dollars are being poured into these trials?

    (4) Finally, because Dr. Patel never blows his own trumpet, I shall. He proved in 2004 trials in South American the superiority of autologous stem cells over standard cardiology, just as virtually every USA trial is doing in 2010. Yet hundreds of thousands will die without the opportunity to improve their lives with stem cells since the Weissmans and the Robbins of the world control their destiny. As long as Big Medicine continues to bring three hundred million dollars A DAY to the bottom line, the USA medical business will remain 19th of 19 developed countries as proven by the Commonwealth Fund in 2006 and 2008. We are already behind Cuba in many areas of medical care. Perhaps the 2010 report will tie us with Rwanda.

  6. Christopher Vaughan Says:

    Thank you all for your comments. As a result, I have posted an update to this entry.

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