Each 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.
- Another stem cell biotech acquisition by pharma (recall Ocata (now finally sold to Astellas) & CDI in 2015). Checkup: Not yet.
- 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.
- Stem cell clinics and doping in sports flares up more. Checkup: Clinics yes, doping not yet.
- Organoids continue to excite. Checkup: Correct. What a great technology.
- 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.
- 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.
- Stem cell clinics ever more aggressively use celeb clients for PR and marketing Why? It is powerful, effective, and essentially free advertising. Checkup: Correct.
- More news on human-animal chimeras. Checkup: Correct. Another hot topic.
- FDA continues its slow-go approach to action on stem cell clinics/unapproved stem cell products. Checkup: Correct.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- ViaCyte has some big news. Checkup: Not yet. What a great company.
- High-profile developments on veterinary use of stem cells. Checkup: Correct. For instance see this piece in Scientific American. Cool stuff!
- Animal cloning, particularly in China, continues to proliferate. Checkup: Correct.
- 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?