Stem cells on the 4th of July: plenty of fireworks lately

It’s an exciting time to be a stem cell scientist and I feel fortunate to be doing research on stem cells today what with all the developments recently and real promise for clinical impact in coming decades. There’s also unfortunately a ton of hype out there including in academia, biotech, and the stem cell clinic arena. That’s something we all need to be aware of and avoid as much as possible.

stem cell fireworks

Hype and hope are only different by one letter (y versus o), but although they are both out there it is often not easy for patients to distinguish these. The hype is flashy like fireworks of the kind we might see today. But often it is more bang than substance and is harmful to the stem cell field and patients.

There’s so much to celebrate in terms of legitimate research across all the spectrum from the lab to the clinic with stem cells. Making an effort to cut back on hype actually helps the field collectively by keeping expectations realistic (even if optimistic)  and avoids disasters like patients being harmed by hyped stem cells. When powerful people engage in hype of stem cells that is even riskier for patients and the field. I’ve been trying to challenge that.

There’s also been fireworks in the stem cell field over policy debates in the past few weeks and months. The fireworks in the debate over stem cell oversight are not fun, but this kind of disagreement may be a necessary part and sign of healthy debate of different policy ideas. Even if we do not sing a stem cell version of Kumbaya together, that’s OK. Group think and silencing of diverse voices are not helpful to put it mildly.

It’s a big, crazy stem cell world out there. Enjoy all the real fireworks this weekend as well as that in the stem cell world related to science and policy that is likely to continue throughout the rest of 2016.

13 thoughts on “Stem cells on the 4th of July: plenty of fireworks lately


  1. I have seen links to your paper many times over the weekend. Kudos on that.. My question after reading the many articles in the various papers is did you or have you come across statistics on how many people have had a negative outcomes in the United States with stem cell therapy? I have seen the “Cautionary Tale” which really stinks for that patient and in no way am I trying to down play it. But it seems like most of the bad press coming from stem cell therapy is from you. I am not trying to accuse you of anything, but I have been researching a lot lately on getting a treatment done for my mother and the negative things that I could find were mainly quotes from you. But on the flip side I found hundreds if not thousands of patients testimonials with great responses.. Do you chalk all that up to a placebo effect?? Are these all made up testimonials? Do yo have a statistic with negative outcomes? When I say negative I mean death or serious infection.. something like that.. When I go to Regenexx and it says that they have performed almost 30,000 procedures it seems to me that if they had an overwhelming amount of people dying or having negative outcomes that he wouldn’t be in business anymore?? It also says on their website that in 2008, over 5000 people died during a routine knee replacement. Why don’t you ever preach about how dangerous knee replacements are. Surely you have a statistic that shows that thousands of people are dying every year with stem cells??

    Or same scenario for Stem Cell Centers of America?? We would want to go to Beverly Hills clinic because he is like the Bosley in hair restoration if that makes sense.

    Ive read quite a bit on your blog and from what Ive seen you never give kudos to practitioners doing good work in a clinical setting.. Seems to me that doctors like ones at Regenexx or Stem Cell Centers of America are doing good work and have patients best interests at heart. But when I read your blog you pool all these clinics together and demonize them as “Donald Trumps” who are only in it for the money. Just my two cents..


    • Hi Dan,where did you find the patients testimonials with great responses.I have copd and I am looking at going into a self payed trial in n.y. he trial # is NCT02216630.It is done with your fat stem cell.How would I find people that did this trial and what they had to say about it.My e-mail address is deegeardino@optonline.net


    • @Dan, These are fair questions.
      The clinics and their patient advocates do a really good job of playing up the potential positives and as you said there hasn’t been much out there on risks so I’ve felt like for the sake of balance it is important to point out the risks here.

      For both potential benefits and risks, there isn’t much published data so this makes things difficult on both sides of the coin.

      In terms of data, I did point out Dr. Centeno’s recent safety paper and discussed it here on the blog: http://www.ipscell.com/2016/04/review-of-centeno-msc-safety-paper-without-controls-conclusions-muted/.

      It’s a definite plus that he collects and publishes data, which is far more than I’ve seen the other groups do.

      The lack of any controls in his study kind of comes with the territory of a for-profit context because patients won’t want to pay for a placebo and the clinic won’t turn paying customers into non-paying controls. However, as a scientist I don’t believe in charging patients to get still experimental unproven treatments. I also have to point out that the lack of controls in that paper (and others like it) makes it very difficult or even impossible to fully understand the meaning of the data.

      I would say that his group’s data are so far consistent with the notion that injection by experienced experts of unmodified bone marrow cells for joint conditions is not an extremely high risk procedure.

      But if someone takes the same kind of cells and uses them to treat a brain or lung condition for example or other conditions that have nothing to do with bone marrow or the bone/cartilage lineage, then that could be much riskier.

      Also, what about efficacy? Are these procedures proven to be statistically more effective than the standard of care? I haven’t seen that.

      I have heard that 5000 deaths/year claim before for knee replacement surgery by others before but have not seen any real data on that. Can you cite a paper or papers?

      Until I see properly controlled data demonstrating safety and efficacy (you’ve got to have both) for these for-profit experimental stem cell offerings, I don’t see how kudos are in order yet. Maybe that day will come.
      Thanks for weighing in with your questions.
      Paul


      • @admin,

        I appreciate your response. The website where I got the statistic from is Regenexx.com. I have seen stats that support 3-4k people dying per year but not the 5000 reported on their website. I will find those statistics for you and papers. But with 3-4k people dying every year from a knee replacement surgery, is that ok with you? Like you said, there aren’t really any statistics that say there is a major benefit or major risks with stem cell injections.. All that I see is benefits from patients that have tried the procedures with good results. Don’t get me wrong, I have seen testimonials that weren’t as great as well. But honestly I have seen more good than bad.

        When I do see negative effects coming from stem cells it is typically with embryonic stem cells. The only clinics that I can find that offer them are not in the United States. Some in Mexico and some in Asia. The clinics here seem to offer bone marrow, fat-derived, and fetal (amniotic or umbilical-cord derived). From everything that I have read on pub med, because Im not sticking just anything in my 74 yr old mother, didn’t seem to be able to cause tumors?? These cells were multipotent vs. pluripotent. If that is the case, what risks should I be worried about when it comes to stem cell therapy in the United States for my mothers knees? I saw above that you stated “bone marrow for joint injections does not seem to be a high risk procedure”.. If the stem cells are only being used for her joints, might it be a good option? Im just going off what I could read on PubMed. Again thanks for taking the time to respond.

        @Jeff,

        Have there been hundreds of expensive clinical trials yielding no results?? My question would be, why are they still researching it then? Why is the author of this blog researching stem cells if there have been “hundreds of expensive clinical trials that don’t report any successes”? What would be the point? My guess is that there really hasn’t been hundreds that yield no results.. Seems to me that there are several brilliant people involved in stem cell research as well in a clinical setting. I find it hard to believe that PhDs would beat a dead horse. Seems like that is a better question for the admin.. But in that same vein my question for the admin would be, Are you currently studying or do you know someone who is studying stem cell therapy for arthritic conditions? If not, why not? If so, who??


        • @Dan,
          I’d like to see an actual published data for knee replacement surgery deaths. On first look, I didn’t find anything remotely like 3,000-5,000 deaths per year.
          Paul


          • @admin,

            I was surprised to find that the information that Regenexx cites is from the National Inpatient Sample database of JUST Medicare patients!! Those numbers could be higher! There were quite a few other serious side effects that Dr. Centeno lists as well. He said that 22,500 patients a year have SERIOUS life threatening complications. Im not sure that Im willing to take those risks.

            On the CDC website it says that ‘currently’ in the US, 700,000 total knee replacements get performed every year. Just using the Regenexx websites claims that they have done 34,000 procedures to compare safety. They would have almost 1100 people who had a serious complication as a result of their treatment to be comparable. Seems like stem cell route is safer. @admin, what do you think?

            When I went the National Inpatient Sample database it was something that I would have to purchase and download. I thought that because you are a researcher, you may already have access to the data. But here is the link to where I read it on Dr. Centeno’s blog.

            http://www.regenexx.com/how-risky-is-total-knee-replacement-surgery/


            • @Dan,
              Dr. Centeno says, “As an example, in the year 2008 alone, 4,964 deaths due to knee replacement were found in this database.” The key part there is “due to”. I’m curious if these deaths are in fact directly attributable to the procedure itself or is this just the # of such patients died from all causes? That makes a huge difference. I’m not sure if I have access to that database or not.
              Another point I’d raise in response to you, Alb, & some others is about efficacy. Despite knee replacement being for sure a very involved medical procedure with risks, my understanding is that the vast majority of the time it is very effective. In contrast, to my knowledge for stem cells used for treatment of knees in similar patients there isn’t solid, controlled data proving anything like that rate of efficacy. Maybe I’m wrong.


              • BMC Musculoskelet Disord. 2016 May 26;17(1):230. doi: 10.1186/s12891-016-1085-9.
                Mesenchymal stem cell therapy in the treatment of osteoarthritis: reparative pathways, safety and efficacy – a review.


              • Stem Cells Transl Med. 2016 Jul;5(7):847-56. doi: 10.5966/sctm.2015-0245. Epub 2016 May 23.
                Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial.


  2. Dan, a good question and one that I have posed from the clinical perspective. I hear about “thousands of patients testimonials with great responses” but cannot find any independent peer-reviewed clinical data from approved trials to support these claims.

    On one hand we have these massive claims of safety and efficacy, in which we suspect at least some good data must exist, and on the other hand hundreds of expensive clinical trials that don’t report any successes. What’s the deal here?


  3. Don’t have a lot of money at all where can my wife go get help for her MS research trials free something I need help we are seeking free stem cell research where can I possibly get that done at is anyone doing it

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