Desperate patients and false hope: a troubling trend for stem cell-based therapies

A gambler’s odds are usually stacked against them but the possibility, however slim, of hitting the jackpot keeps bringing them back to the table. Now imagine, unbeknownst to them, the system is rigged so there’s a zero percent chance of any winnings. They’d essentially be giving their money away based on a false hope. Sadly, many desperate people looking for stem cell cures do exactly that.

Earlier this week, Cristin Severance, a Team10 TV news reporter in San Diego, investigated local stem cell clinics promising treatments for a number of chronic incurable diseases. Severance cites Stemgenex of La Jolla, which offers people with Parkinson’s disease the chance of improving their symptoms through a therapy using stem cells from their own fat. This opportunity comes at a cost – $15,000. According to stem cell expert Jeanne Loring of The Scripps Research Institute, there’s no prospect the treatment will work.

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Cristin Severance, a Team10 San Diego TV news reporter, investigated local stem cells clinics offering questionable therapies at a steep price.

First, some background: Parkinson’s disease is an incurable neurodegenerative disorder that affects nearly a million people in the United States. The symptoms include tremors, slow movement, muscle rigidity and less facial expression. Parkinson’s occurs when nerve cells, or neurons, in the region of the brain that controls movement, die for reasons that remain unclear. Which leads us to the snag with Stemgenex’s treatment strategy. Dr. Loring, who is a CIRM-funded researcher, explains in the TV news segment:

“The cells they are giving these patients cannot help them. My stem cells [in my laboratory] make neurons of a certain type. The stem cells they are getting out of people’s fat can’t do that. They could never do it. They aren’t capable of it.”

But what about the positive video patient testimonials often posted on these clinics’ websites? Watch enough of them and you’ll notice a pattern: the patients are typically recorded shortly after the treatment with no long-term follow up and no published data in peer-reviewed medical journals. Loring points out the likely explanation for these seemingly successful treatments:

“There is something called a placebo effect…If you believe whatever you’re getting is going to help you then there’s a short period of time in which your body is convinced that it has helped you. But that goes away.”

A plausible approach to treating Parkinson’s is to start with so-called pluripotent stem cells, which have the potential to specialize into any cell type. With these cells in hand, scientists can generate the neurons that are lost in Parkinson’s – a feat Loring and others have accomplished. The next step is to inject these neurons into the brains of Parkinson’s patients to restore—hopefully—proper movement control. But first the researchers must gather enough evidence in animal studies to convince the Food and Drug Administration (FDA) that this therapy is safe and effective enough to test in humans.

So what about people who need stem cell cures today, right now? The sobering truth is, there are very few stem-call based products approved by the FDA. Most of those involve blood stem cell transplantation for treating leukemia and some genetic blood disorders as well as the use of stem cells for skin and hair grafts and cartilage repair.

Still, more and more stem cell-based clinical trials are coming online and recruiting people with a wide range of diseases. Everyday at CIRM, we receive emails and phone calls from people looking for advice about these experimental stem cell treatments. Our main recommendation: carefully read an excellent online resource provided by the International Society for Stem Cell Research (ISSCR) called, A Closer Look at Stem Cell Treatments. In particular, the Things to Consider about Clinical Trials section includes a list of questions anyone thinking about participating in a stem cell trial should ask. It would be a good idea to get the answers in writing and discuss them with a physician you trust. That way, you can truly know your odds when forming a decision.

Visit our website for more information about stem cell-related Parkinson’s research as well as the current list of CIRM-funded clinical trials.

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15 thoughts on “Desperate patients and false hope: a troubling trend for stem cell-based therapies

  1. Todd- thank you for reporting on this story. I was very impressed by the amount of research that Ms. Severance put into the story- it was the best, most accurate report I’ve seen on the subject. Perhaps you noticed that I was interviewed at my home- the investigative reporters wanted it to be clear that my institution and I were not criticizing any specific clinics. It was very professionally done, and I hope that it has impact.

  2. James- I appreciate your commentary, but I really must correct some of your misconceptions about iPS cells.

    Your statement: “How are the induced pluripotent stem (iPS) cells produced?” Currently, iPS cells are produced by inserting copies of four stem cell-associated genes; Oct 3/4, Sox 2, Klf4, and c-Myc …into specialized cells using viral vectors”.

    Fact check: The genes used to reprogram cells to iPS cells do NOT have to be inserted into the genome and even using viruses is no longer necessary. We use a non-integrating virus that delivers the reprogramming factors to the cells but never touches the genome. Our extensive whole genome sequencing analyses of iPS cells prove that.

    Your statement: “What are the advantages of iPS cells over embryonic stem cells?The advantage of iPS cells is that they are not derived from human embryos, which is the ethical concern in this field. By removing the bioethical issues, the scientists are more likely to obtain more federal funding and support. Another significant benefit of iPS cell technology would permit for creation of cell lines that are genetically tailored to a patient. This could eliminate the concern of immune rejection, where the body’s immune system identifies implanted cells or tissues as unknown and attacks them.”

    Fact check: We use iPS cells for two reasons- the lack of rejection and the fact that we can exert stringent quality control on every aspect of their production. The federal funding issue is a myth.

    Your statement: “What are the risks associated with iPS cell use in humans?
    The retroviruses used in the generation of iPSc are associated with cancer because they insert DNA anywhere in a cell’s genome, which could potentially trigger the expression of cancer-causing genes. Another risk associated with iPS cell technology applied to humans is the fact that c-Myc, which is one of the genes used in reprogramming, is a known oncogene whose overexpression could also cause cancer.”

    Fact check: We don’t use retroviruses, so none of the reprogramming genes is left in the genome. We sequence the cells to prove this.

    Your statement: “How are iPS cells similar to ES cells? iPS cells are similar to ES cells in morphology, teratoma formation, proliferation, as well as their ability to differentiate along a given lineage. They also express cell surface markers and genes that characterize ES cells.”

    Fact check: This is correct. The teratoma assay was used to show that cells are pluripotent (able to make every cell type in the body) – we have better ways to do this with genomic assays now.

    Your statement: “Does iPS cell technology eliminate the need for embryonic stem cell research? Recent advances do not eliminate the need for ES cell research since it is not yet quite clear whether iPS cells differ extensively from the embryonic stem cells. To bring stem cell research to clinical realization, it is necessary to investigate all the aspects in this field.”

    Fact check: It is actually quite clear that embryonic stem cells and iPS cells do NOT differ from each other. See the publications by Yamanaka’s lab, Meissner’s lab, and my lab.

    The value of iPS cell technology doesn’t require opinions – the facts are all in.

    • Although iPSCs are a very exciting discovery and have lots of potential to manage many chronic diseases, there is still a big problem which in my opinion has yet to be sufficiently solved. Even if you generate perfect iPSCs, when you actually put them in the body, can you really replicate the functions of the damaged/killed cells you are trying to replace? Especially in any neurological disease like Parkinson’s, how can you possibly regenerate all the precise synaptic connections you need to perfectly regain function? iPSC technology, although exciting, definitely has a ways to go before these types of (incredibly expensive) treatments should be recommended to patients.

  3. I have been treated by StemGenex … not for Parkinson’s, for Type 1 Diabetes and a myriad of other “diagnoses”. If you are going to tell me that my labs are a “placebo” effect, I am going to shout … BS!! I get the “tourist” issue and “desperation” of patients. However, if the $$ raised for some of these diseases actually went to the research and implementation of these treatments …. patients wouldn’t have to gamble with their health. Would they … ??

  4. Stemgenex is a hoax! They only want the $$ from those patients who are desperately needing cure and will immediately dispose money if given a single ray of hope! And they don’t have board-certified physicians, this is illegal practice of medicine. FDA should know.

  5. To Casey Vickstrom:
    Your question is good, and I have an answer.
    “…how can you possibly regenerate all the precise synaptic connections you need to perfectly regain function..?”
    The answer is that for Parkinson’s disease, precise synaptic connections are not necessary. This remarkable discovery was made in the 1980s, when several groups transplanted the fetal precursors of the substantial nigra- actual dissected fetal tissue- into the brains of several dozen PD patients. Using fetal tissue is far from ideal, because the quality is highly variable, and there are a lot of unwanted cell types in the tissue. But, in some cases, it worked! The researchers transplanted these tiny chunks of fetal tissue into the striatum. the part of the brain that receives synaptic input from the substantial nigra. The dopamine neurons in the transplanted tissue connected with the cells that the substantia nigral dopamine neurons used to connect to, and they functionally corrected the motor deficits. So we don’t need to recapitulate the precise connections- the transplanted cells connected and they worked. This means that a stem cell-derived dopamine neuron replacement therapy for PD is likely to work, and will almost certainly be better than fetal tissue.
    My favorite account of this work is a book by Curt Freed, called “Healing the Brain”, but there are a lot of articles on the subject if you google fetal cell transplants for Parkinson’s disease.
    The expense for patient-specific iPSC therapy for PD will be similar to the patient-specific immunotherapy for cancers (CAR-T).

  6. Stemgenix is a ripoff. I attended for $14,500 along with 3 others. We all have seen no results. $58,000 for 1 day , that was 1 1/2 yrs. ago. Someones living high .

  7. Pingback: A Shady Trial? | In the Pipeline

  8. Hi,

    I am an MS patient that worked with Stemgenex. I paid $15k for my procedure and I haven’t looked back. I am completely symptom free and I am a testament that this is not a hoax or a rip off. The CEO, Rita is an amazing human being and is in remission from having an auto-immune disease herself from having recieved stem cells. If it wasn’t for her and her team I would be still be paying $4300 for a drug that had more side-effects than good to keep my symptoms at bay. Multiply that number by 12 and THAT number by how many years you have left on this earth. It’s a whole lot more $15k. I’d see the drug industries are the ones getting away with murder and putting that “false hope” there. Granted, each person’s condition is different and some people require more than one treatment. I did mine when I was newly diagnosed NOT when it was too late and the damage had already severely been done. I stand by stemgenex and will continue to be a soldier in their fight to eventually get stem cells covered under one’sinsurance.

  9. Kristen,
    Congrats on your progress. This article is over a year old, I commented on it prior. I find it really odd that with the upcoming FDA hearing coming up that this, and a couple of other derogatory articles attacking StemGenex are surfacing again. In the times I have been treated by the doctors/team at StemGenex I have NEVER been promised a cure of any kind. Science has already proven that we have the ability to heal our own bodies. While Ms. Loring may be doing fine work in researching advanced applications of our own stem cells, it will no doubt involve some sort of manipulation, therefore making some big pharma a lot of money. My mother suffered from Parkinson’s disease, I can say without a shadow of a doubt that if she were still alive today we would be searching out StemGenex, if for nothing more than an improved quality of life while those who research for cures seem to have a lot of time to bash others. That is questionable behavior to me as a patient. I know I am going to die waiting for that cure that is never going to come because those that are attempting to do good are being bad mouthed. Using my own cells has been life changing for me and I will continue to advocate for such therapies. As in any pharmaceutical, some people show great benefit, while others see none, and still others who are never quite honest and straight forward before undergoing any sort of treatment. I am really getting angry at those who keep referring to my benefits as “placebo effect” or “anecdotal.”

  10. Eliza:
    I realize that much of what you say is about your feelings, and I can’t argue with what you feel.
    But I want you to understand that there is no pharma company supporting my work or any of the other iPSC projects that are undergoing FDA approval. We aren’t making money- every penny goes to the lab so that we can develop a therapy that works for patients and is grounded in scientific evidence. The process of developing an evidence-based therapy is not nearly as easy as opening a for-profit clinic to deliver treatments that have no basis in science. Please check out the webpage for Summit for Stem Cell- it explains the science and the motivation. http://summitforstemcell.org/

  11. I can’t believe Stemgenex has even gone on this long. They don’t have any board-certified physicians. They are virtually practicing medicine illegally!

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