Top 20 Stem Cell Predictions for 2017

stem cell crystal ball

Stem cell crystal ball

Each year I make a list of predictions for the stem cell and regenerative medicine field for the coming new year. Later in this post I list my top 20 stem cell predictions for 2017. In looking at my past predictions I realized this will now be my 7th year doing stem cell/regenerative medicine yearly predictions.

You can see below links to these predictions for past years, which sometimes seems rather far removed from today and in other cases strike me as strangely apropos of our times.

What will 2017 bring? Below are my top 20 predictions in no particular order except starting with a few hopeful visions for the coming year.

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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.

REGROW Act, Mark Kirk Lobbying & Contributions Yield Stem Cell Surprises

Center for Responsive PoliticsThe money behind a piece of legislation can provide unique insights into the back story and this is definitely true for the REGROW Act that would reduce FDA oversight of the investigational use of stem cells in patients.

Senator Mark Kirk of Illinois, who is facing probable defeat next week in his reelection bid according to polls, has been the leading backer of the REGROW Act. Kirk has been more in the news of late due to extremely controversial Trump-like comments he made about his opponent, veteran Tammy Duckworth. Some have characterized these comments as “racist” and inflammatory.

Kirk has received campaign contributions from a number of businesses involved in stem cell product development that could stand to benefit financially if there was weaker oversight by the FDA. Data on these contributions come from research on the Center for Responsive Politics website (note that only the top 100 are listed there out of thousands of contributors, while others can be searched for manually, and the list changes over time). This money came directly or more often indirectly to him, as sometimes contributions came from second parties or employees.

Certainly, companies may contribute to Kirk just because they like him overall and with no specific interest in REGROW, but it seems to be his signature piece of legislation these days.

Senator Mark KirkU.S. “Big Pharma” companies Baxter and Abbott Laboratories contributed to Kirk. A small contribution came from Astellas Pharma, a Japanese big pharma company involved in stem cell clinical research (e.g. it bought the small American stem cell biotech Ocata last year). The “drop in the bucket” donation from Astellas to Kirk is notable if nothing else symbolically because in Japan the stem cell clinical arena has recently been subject to substantially reduced regulatory oversight and proponents of REGROW often point to the Japanese stem cell regulatory system as a model for what they want to achieve in the U.S.

A $10K contribution to Kirk’s campaign came from MiMedx Group, a stem cell company with some history with the FDA. I did a post on MiMedx in 2013 here on this blog because of an FDA letter sent to the company regarding its unusual placental “stem cell magnet”. More recently, the financial website The Street also reported in May of this year that MiMedx filed suit against another stem cell company, Osiris, for “allegedly falsifying and misleading consumers with clinical data.” That’s a pretty harsh allegation, but I’m not aware if there’s any hard evidence to back it up.

MiMedx made this remarkable claim at that time about why its product doesn’t need further testing:

“Mother nature did safety and efficacy testing on the tissue,” MiMedx CEO Pete Petit told ABCNews.com, likening treatment with a placenta-based product to a kidney transplant rather than the use of a drug. Since the placenta product is made from human tissue, he said testing is unnecessary because placental cells already work in the human body.”

More broadly, according to the Center for Responsive Politics, 26 groups in all are registered to lobby on REGROW, a collection of entities including some for it and some against it. REGROW is also reportedly being promoted by Ed Bosarge, whose company Bosarge Life Sciences is on that REGROW lobbying list.

Overall, there have been hundreds of thousands of dollars spent on REGROW lobbying including from big pharma. Some of the more vocal proponents for less FDA oversight of stem cells have claimed for years that the big pharma industry has interfered with stem cell treatment development and has undue or even corrupt influence on the FDA to block patients getting access to stem cells. This always seemed like a wild conspiracy theory to me and now with these data on lobbying we can all confidently say that “Big Pharma opposing stem cells” myth is officially 100% busted.

Some might argue that some big pharma being supportive of REGROW is a sign that the bill is meritorious. Notably, however, some other groups including industry associations are opposed to REGROW as well including the Alliance for Regenerative Medicine (ARM).

REGROW has also evolved over time to be less extreme and I wonder if in yet another new incarnation the bill could be more balanced in the future so that it might garner more broad support within the stem cell community. I hope so. The goal of getting stem cell and regenerative medicine therapies to patients more efficiently is a noble one that I support as long as it doesn’t sacrifice the common sense, biomedical science-based need for rigorous data on safety and efficacy in the process.

It’s important to point out for context that certain companies lobbying on REGROW and/or contributing to Kirk also give out dozens of contributions all the time to many different lobbying and election efforts. This means that REGROW might be just one of many targets for them and in some cases the dollar amounts aren’t huge, but still REGROW is clearly on their radar screens.

What is happening now and will happen in the future? It’s interesting to speculate about whether the FDA is under political pressure and subject to lobbying to weaken or back down on its four guidances related to stem cells that are still in draft form, but to my knowledge there is no publicly accessible information on this area of lobbying. If anyone has information on that, please share it with the community.

Stem cell predictions top 20 list for 2016

Stem Cell PredictionsWhat will the new year have in store for stem cells?

2016 promises to have many striking stem cell developments. Below are my top 20 stem cell predictions for what is to come this year in no particular order. Share your stem cell tea leaves in the comments please.

  1. Another stem cell biotech acquisition by pharma (recall Ocata (almost now finally sold) & CDI in 2015).
  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
  3. Stem cell clinics and doping in sports flares up more
  4. Organoids continue to excite
  5. Bioheart and some other small stem cell companies struggle
  6. Stem cell stocks overall have a bad year
  7. Stem cell clinics ever more aggressively use celeb clients for PR and marketing Why? It is powerful, effective, and essentially free advertising
  8. More news on human-animal chimeras
  9. FDA continues its slow-go approach to action on stem cell clinics/unapproved stem cell products
  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 upcoming public hearing on the draft guidances
  11. FDA receives increasing public criticism for “slowness” on approving new stem cell therapies including from beyond the stem cell clinic industry
  12. One or more lawsuits against a stem cell clinic
  13. A new stem cell scandal pops up related to publication issues
  14. Some hiccups on mitochondrial transfer/3-person IVF in the UK or China
  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.
  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
  17. ViaCyte has some big news
  18. High-profile developments on veterinary use of stem cells
  19. Animal cloning, particularly in China, continues to proliferate
  20. More rumblings on possible human reproductive cloning attempts

Disclaimer: This post is not meant as financial advice. Consult an expert before making financial decisions.

Prospects for stem cell stocks in 2016

stem cell stocksMoney plays a major role in the arena of stem cells, cell therapy, and regenerative medicine. The financial side of this cutting-edge field ranges from grants to private investors to publicly traded stocks. One could argue that the flow of total investment going into this area has a direct and tangible impact on how rapidly and effectively the research moves forward.

In the specific area of publicly traded companies working in stem cells, cell therapy, and regenerative medicine, what’s the investment outlook for the coming year? How will stem cell stocks do?

I’m not an investment expert so don’t take this post as financial advice, but overall things look pretty mixed for 2016. On the one hand, there have never been more clinical trials and ones with real potential, which is a great positive hallmark. On the other hand, for many stem cell companies what seems to be “good news” does not always equate to consistent increases in the stock PPS or company valuation. It’s a super high-risk arena for investors.

Pharma purchases in 2015 of stem cell companies such as CDI and Ocata can also be viewed in polar opposite ways. This could signal more purchases/acquisitions of stem cell biotech’s coming in 2016 and that could both help get treatments to patients and benefit investors, but will the price be right and does it translate to a positive outcome for investors? Many investors are very unhappy about the price paid for Ocata. What do you think of that sale?

What are your favorite stem cell stocks as you look ahead to 2016 and why? Do you see acquisitions coming? What about IPOs? Could an exciting stem cell company such as ViaCyte do an IPO in the next 12-24 months?