A nation of stem cell miracles? CNN puff piece on clinic patient & Trump blows it

CelltexWould you believe in a stem cell miracle?

Sometimes the mainstream media stumbles in its coverage of the stem cell world and a recent CNN puff piece on a patient of stem cell clinic Celltex is a prime example of just how extreme this can get.

The CNN piece focuses on a Celltex patient who self-reports perceived big improvement after receiving the non-FDA approved offerings of the Texas stem cell clinic. Celltex is most famous for their number one customer and supporter Rick Perry, former Governor of Texas and now DOE Secretary in the Trump administration. For more background on Celltex including the warning letter it received from the FDA, you can see archived posts here.

CNN stem cells

Jacqueline Howard of CNN wrote about how the patient was invited to and attended Trump’s big speech before Congress recently. Howard mostly blew it on this article as she provided no background on the controversy involving Celltex, its past run in with the FDA, and how its offerings that it sells to patients are not FDA-approved as safe and effective. Minor details, right?

What about the fact that these kinds of treatments cost the average patient thousands of dollars, sometimes tens of thousands of dollars? Not important enough to mention?

And risks? No mention. The reality is that using adipose stem cells grown in a lab has sizable risks. Continue reading

Grading my top 20 stem cell predictions for 2016: how’d I do?

Below are the 2016 stem cell predictions I made last year and their status now color-coded near year’s end. Green is right, orange is mixed bag, and red is flat out wrong.

Overall, I did better than most past years with only having entirely blown it on four.

Stay tuned later this week for my 2017 predictions, which looks to be a dramatic year in the field of stem cells and regenerative medicine.

The Score Card on 2016 Predictionsstem-cell-predictions

  1. Another stem cell biotech acquisition by pharma (recall Ocata (now finally sold to Astellas) & CDI in 2015). Grade: Some acquisitions, but not huge news.
  2. Charging patients for clinical trial participation, particularly in Japan due to the new policy and here in the US related to predatory clinics remains a hot topic. Grade:  Correct.
  3. Stem cell clinics and doping in sports flares up more. Grade:  not really the two together.
  4. Organoids continue to excite. Grade:  Correct.
  5. Bioheart and some other small stem cell companies struggle. Grade:  Correct.
  6. Stem cell stocks overall have a bad year. Grade:  Unfortunately, generally correct.
  7. Stem cell clinics ever more aggressively use celeb clients for PR and marketing. Why? It is powerful, effective, and essentially free advertising. Grade:  Correct.
  8. More news on human-animal chimeras. Grade:  Correct.
  9. FDA continues its slow-go approach to action on stem cell clinics/unapproved stem cell products. Grade:  Sadly correct.
  10. Pressure from industry and some academics on FDA to not regulate adipose products as drugs and/or to not enforce some other draft guidances including at the public hearing on the draft guidances. Grade:  Correct.
  11. FDA receives increasing public criticism for “slowness” on approving new stem cell therapies including from beyond the stem cell clinic industry. Grade:  Correct.
  12. One or more lawsuits against a stem cell clinic. Grade:  Correct in a big way. E.g. versus U.S. Stem Cell, Lung Institute, and Stemgenex.
  13. A new stem cell scandal pops up related to publication issues. Grade:  Correct. You just have to go visit Retraction Watch (e.g. the Spain mess), For Better Science, or PubPeer, and then also see the continuing Macchiarini debacle in particular.
  14. Some hiccups on mitochondrial transfer/3-person IVF in the UK or China. Grade:  Correct. Diseased mitochondrial carry-over and mito-nuclear cross-talk issues have popped up and deserve serious attention. Remarkably, nevertheless UK folks are going forward with it in humans anyway.
  15. The trend last year of increasingly blurred lines between legit research entities such as universities and dubious stem cell enterprises continues. This is worrisome. Grade:  Correct. For instance, see Rasko paper.
  16. Stem cell-derived human germ cells stay in the headlines. This has exciting potential for providing new windows into human development and tackling infertility, but also raises thorny issues such as human genetic modification. Grade:  Correct.
  17. ViaCyte has some big news. Grade: Not yet… 
  18. High-profile developments on veterinary use of stem cells. Grade:  Correct. 
  19. Animal cloning, particularly in China, continues to proliferate. Grade:  Correct.
  20. More rumblings on possible human reproductive cloning attempts. Grade:  Some here and there, but not much. See this piece on cloning focusing on 20th Anniversary of Dolly.

The car shopping analogy for evaluating stem cell clinics

Patients contact me all the time these days asking about American stem cell clinics. The most common question boils down to “should I get a treatment at clinic X and what things should I think about in trying to make this decision?” I recommend checking out my stem cell treatment guide for patients.used-car-sales

In addition, you might consider an analogy to car shopping. I’ve found it is very helpful.

Buying a car is a much less serious decision than getting a stem cell therapy, but it is sometimes not taken as seriously from a practical point of view in terms of what goes into the decision making.

If you are going to buy a car ranging in price from say $10,000 (maybe a used Honda) up to $30,000 or even $50,000 or more for a car, you do your homework, right?

Continue reading

Some stem cell clinics respond to Cell Stem Cell paper with ‘not me, them’

There has been relatively limited response from clinics themselves to the Cell Stem Cell paper that Leigh Turner and I published recently on the scope of the stem cell clinic industry in the U.S. Not Me stem cells

We found 570 stem cell clinics and there could easily be 50-100 more that escaped our search methods or that have popped up since we finished our search at the end of February. While not all the clinics necessarily require FDA approval depending on the type of stem cells and the uses, it seems almost certain that many should have gotten approval from the FDA for what they are doing before they started selling the unproven “treatments”.

One thing I was curious about before our paper even came out was what kind of response, if any, it would get from the stem cell clinics. It’s been pretty quiet from that quarter.

A few clinics talked to reporters who covered the paper and basically used some version of the same mantra, “not me, them”. This reminds me of the Family Circus “not me” cartoons (part of one is shown above).

Continue reading

New paper shows huge American stem cell clinic industry: 570 locations

My colleague Leigh Turner and I today published a new paper in Cell Stem Cell documenting for the first time the American stem cell clinic arena in a comprehensive way, which we found as of February has a remarkable 570 clinic locations via 351 businesses.

These numbers are way beyond the predictions of most researchers and policy makers for stem cell clinics in the U.S., and point to a burgeoning, huge industry from coast to coast (see map below of clinic locations that we found in our research that is Figure 1 of the paper).

Figure 1 Turner Knoepfler Stem Cell Clinics

We focused on those businesses that as best as we could determine do not have FDA approval for marketing stem cell treatments. This means that even if relatively few patients are seen at each of the 570 locations, tens of thousands of Americans each year may be getting stem cell offerings that do not have formal FDA approval.

The businesses in general market fat, bone marrow, and amniotic-related stem cells for a surprisingly wide range of conditions too, pretty much from head to toe and A to Z in a medical dictionary of conditions. It’s not clear scientifically if there are data to concretely support the use of these types of stem cells for such a wide spectrum of conditions.

Our goal was to document this direct-to-consumer marketed industry as fully as possible even as we excluded those businesses that had INDs or operated outside the U.S. A challenge in that regard is that the FDA keeps information about INDs private.

Importantly on the other hand some businesses while having no formal FDA approval may still be compliant because they fall within specific categories of usage. For instance, in some cases with a subset of these clinics such as those that use largely unmodified bone marrow cells for autologous use in homologous orthopedic conditions, no FDA “drug” approval is likely needed.

However, in many other kinds of treatment scenarios that we documented there is a strong likelihood that FDA pre-approval would be needed because of issues such as non-homologous use and/or more than minimal manipulation. Such a large industry with unclear regulatory oversight and pre-approval is a big concern overall.

Still, I do not condone the use of words like “non-compliant” or “shady” to describe all at once this entire clinic marketplace or to characterize the full list of businesses in our database because of a number of reasons including the issue mentioned above with bone marrow being used in a homologous way in some cases as well as the overall complexity of this arena and the lack of clarity from the FDA.

I’ll have more to say about the paper, but I hope you find it a valuable resource.