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.

Stem cell checkup: how are my 2016 predictions doing half way?

Stem Cell PredictionsEach December I make stem cell predictions for the coming year and I did that for 2016 where I made 20 predictions. At around mid year I do a checkup on how my predictions are doing halfway and that is the purpose of this post.

Below are my predictions that I made in 2015 for stem cells in 2016 and my general sense in green of where they stand. Overall, I’m doing reasonably well, but I kind of wish I wasn’t because so many of these are not positive developments. However, in general I remain very optimistic for the field and expect major positive advances in coming years on a number of fronts using both adult and pluripotent stem cells.

The predictions and status so far.

  1. Another stem cell biotech acquisition by pharma (recall Ocata (now finally sold to Astellas) & CDI in 2015). Checkup: Not yet.
  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. Checkup: Correct.
  3. Stem cell clinics and doping in sports flares up more. Checkup: Clinics yes, doping not yet.
  4. Organoids continue to excite. Checkup: Correct. What a great technology.
  5. Bioheart and some other small stem cell companies struggle. Checkup: Correct so far. The PPSs of small stem cell biotechs have generally not been pushed up this year by investors, but rather the reverse. Note that Bioheart is now called US Stem Cell, Inc. We can all hope that there is a turnaround for small stem cell biotechs in the market in the 2nd half of the year.
  6. Stem cell stocks overall have a bad year. Checkup: Correct so far also sadly. Note, by way of disclosure I do not currently have any direct stem cell stock investments.
  7. Stem cell clinics ever more aggressively use celeb clients for PR and marketing Why? It is powerful, effective, and essentially free advertising. Checkup: Correct.
  8. More news on human-animal chimeras. Checkup: Correct. Another hot topic.
  9. FDA continues its slow-go approach to action on stem cell clinics/unapproved stem cell products. Checkup: 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 upcoming public hearing on the draft guidances. Checkup: Correct. REGROW and other efforts have been unprecedented. Note that the FDA public meeting will now be held in September rather than in April.
  11. FDA receives increasing public criticism for “slowness” on approving new stem cell therapies including from beyond the stem cell clinic industry. Checkup: Correct in a big way. 
  12. One or more lawsuits against a stem cell clinic. Checkup: Correct and several more seem to be brewing. Note that it appears that the part of the suit involving US Stem Cells, Inc. has been settled, while a separate part of the case against other defendants continues.
  13. A new stem cell scandal pops up related to publication issues. Checkup: Correct. You just have to go visit Retraction Watch (e.g. the Spain mess) or PubPeer, and then also see the continuing Macchiarini saga.
  14. Some hiccups on mitochondrial transfer/3-person IVF in the UK or China. Checkup: Correct. Diseased mitochondrial carry-over and mito-nuclear cross-talk issues have popped up and deserve serious attention.
  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. Checkup: Correct.
  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. Checkup: Correct.
  17. ViaCyte has some big newsCheckup: Not yet. What a great company.
  18. High-profile developments on veterinary use of stem cells. Checkup: Correct. For instance see this piece in Scientific American. Cool stuff!
  19. Animal cloning, particularly in China, continues to proliferate. Checkup: Correct.
  20. More rumblings on possible human reproductive cloning attempts. Checkup: Not much concretely yet. See this piece on cloning focusing on 20th Anniversary of Dolly.

Stay tuned as near the end of 2016 I will do a final assessment of how I did on my stem cell predictions and then make stem cell predictions for 2017. What are your stem cell predictions?

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.

News bites & rumors on genetic modification of human embryos

crispr nihA lot has happened in the week since the first human embryo genetic modification paper was published by a team led by Junjiu Huang.

There have been a number of new events just in the last few days.

Jocelyn Kaiser over at SCIENCEINSIDER has a new piece reporting a couple important developments including that the journal that published the human embryo editing paper, Protein & Cell, has issued an editorial explaining the review process for the paper. They argue that the review was fast, but appropriate:

“Due to the scientific value and ethical dispute of this study, we not only conducted scientific peer-review, but also consulted related publishing and ethical experts,” wrote Rao, a structural biologist at Nankai University in Tianjin, in an e-mail to Science. “The authors also revised the manuscript based on our suggestions,” he added. He explains that the journal typically reviews submitted papers within 2 weeks, but for significant work they expedite the process. (A Springer representative tells Nature News that review went quickly in part because Huang and his colleagues also submitted the peer-review comments provided to them by Nature and Science and had revised the paper with them in mind.)”

Kaiser also reports that the Society for Developmental Biology has called for a moratorium on any editing of human embryos including in vitro. From the statement:

“SDB supports a voluntary moratorium by members of the scientific community on all manipulation of preimplantation human embryos by genome editing. Such studies raise deep ethical concerns on their own, and in addition could lead to unanticipated consequences if manipulated embryos were implanted into a womb and allowed to develop to term.”

NIH has now issued a statement as well on human embryo genetic modification reiterating that no NIH funding can be used for this kind of work. In addition they remind us that the FDA would have regulatory authority over any attempt to clinically use human genetic modification technology. I’m not so convinced that the FDA could or would do much proactively or even reactively about rogue attempts to make GM people frankly, unless some political pressure came to bear. Note that the NIH also included a nifty CRISPR graphic in the post on their statement that I have pasted above.

The concern over human modification and the potential for designer babies in the future from this kind of technology is gradually entering the public consciousness. Eric Schadt of the Icahn Institute was interviewed on a segment on CBS This Morning on these concerns. I have to say it was a very strange interview with the hosts peppering him with mostly positive-biased questions about what this technology might do if used in actual people and very little discussion of risks.

What’s going on behind the scenes with human embryo genetic modification? Things are still pretty murky out there with many rumors out there. There seems to be a consensus amongst rumors, for whatever it is worth, that at least one more paper will be published this year from another team in China and probably more than one, probably not in top impact journals. Another bit of chatter is that a future paper will have American authors on it even if the actual embryo editing did not occur in the US, although others think that a paper from a team in the US could be in the works.

I don’t know if it is connected to the sense of tension over possible future attempts at clinical germline human genetic modification, but concerns over the potential for attempts at human reproductive cloning are also bouncing around presently. Both cases highlight emerging possibly quick difficult dual use dilemmas in the life sciences.

Human Cloning in Art: Daisuke Takakura 高倉 大輔 Powerfully Captures Essence

I’ve been thinking a lot lately about how the future of human reproduction might be very different from today’s reality due to recent technological advances.

Things like human cloning (the reproductive, “Star Wars” kind) and human genetic modification seem very real now.

It feels almost imminent in a sense compared to the milleenia of the “old fashioned” natural way of making babies.

Daisuke Takakura 高倉 大輔

I find this technology both fascinating as a scientist and also mind-blowing as a science writer. In fact, I’ve become so interested in it that I’m writing a book on it now. It will be my second book following up on Stem Cells: An Insider’s Guide.

As I’ve been learning more about this topic it has started to resonate for me just how much it has already been the focus of art and literature.

A recent art exhibit really struck a chord with me by gifted artist Daisuke Takakura 高倉 大輔. Follow on Twitter @Schrodinger678 and Facebook.

In the images from Daisuke’s collection, including the two shown here, there is a powerful sense of what it might feel like to have a new reality of human clones.

Beautiful work!

Human cloning

You can see more of Daisuke’s work here.

Daisuke will also participate in fotofever at PARIS PHOTO in November.