√ Grading My Twenty 2017 Stem Cell Predictions

Each year I make a list of predictions for the year to come for the stem cell and regenerative medicine field.

Then about a year later I grade myself on how I did as that year winds down. Here’s how I did in 2016.

For 2017, late in 2016 I made 20 stem cell predictions. Let’s now see how I did.

I was wrong on 6 out of the 20 predictions and mostly right on the rest with some others in the middle that I colored orange. For these orange “on the fence”-graded ones sometimes there’s conflicting gosip and other times my prediction was right but the gosip is not in the public domain.

Stay tuned for my list of predictions for 2018 coming soon.

Below are my original 2017 predictions and then my grading of them now in color with some more specifics in some cases on what happened in 2017 or complexities after the grade.

1. Positive news from Asterias on trial for stem cell-based therapy for spinal cord injury. Grade: Correct, trial looking encouraging so far.


2. Upbeat news from ViaCyte on stem cell-based therapy trial for diabetes. Grade: Correct, raising more than $10M and things looking promising.


3. More positive news from the old Ocata now under Astellas umbrella on trial use of stem cell-derived RPE for Macular Degeneration. Grade: Wrong. It’s been a bit too quiet on the former ACT front. I haven’t even heard any rumblings.


4. Good news on the 4dukt stem cell front on trials for one or more major diseases. At least one and probably more positive developments here. Grade: Correct, lots of good news. The potential for stem cell-generated blood is just one example.


5. Fake news hits stem cell arena. Stem cell clinics use fake news a lot. Grade: Correct, unfortunately.


6. More clarity on clinics: data. More academic publications on the practices and outcomes of stem cell clinics are published, bringing greater clarity to what is going on with actual data. Grade: Yes, including from colleagues Leigh Turner and Doug Sipp.


7. More lawsuits against stem cell clinics. There has been a lot of buzz on this behind the scenes already and cases popping up in 2016. This is going to grow in 2017. Grade: Correct plus some not yet in the public domain.


8. Concrete clinic harms. We learn more about additional examples of patient who feel they’ve been harmed by American stem cell clinics including in particular alleged clinic-caused blindness. Grade: Correct.


9. Some other federal agency besides the FDA makes news on stem cells. Grade: Wrong. We’ll see if 2018 brings anything on this front.


10. At least one FDA guidance is finalized. The FDA finalizes at least one of its four recent stem cell-related guidances, but probably not all four. Grade: Correct. Spot on in fact with two finalized guidances. See here.


11. More than one warning letter. The FDA issues more than one warning letter to stem cell clinics in this year. Will it still be a drop in the bucket or some kind of decisive action? The FDA may have more difficulty taking action within the Trump context and much will depend on who is the new Commissioner.  Grade: Technically there was only one such letter this year in the public domain, but I believe more are already in the works and possibly were already issued that we just don’t know about yet publicly.


12. Japan IPSC trial starts. Great news as at least one IPSC trial begins in Japan. Maybe two. Grade: Correct. 


13. Cures yields regen med IND. The FDA takes at least one accelerated stem cell-related IND action traceable to the Cures Act related to a promising new stem cell/regenerative medicine therapy. Hopefully no direct to consumer businesses try to tap in. Grade: Quite a few RMATs were granted, but it’s not clear if they led to INDs. IND gosip is often confidential for quite some time. So this prediction goes in the orange category too.


14. Athersys, Cytori, and Mesoblast have some ups & downs amongst them. Grade: Correct. 


15. Prop 71 2.0. CIRM and/or Prop 71 supporters start more openly talking about a new round of CIRM funding. This may include mention of Trump as problematic for the stem cell field and the continuing need for California to take the lead. . Grade: Correct. More concrete talk occurred on the plan for a new funding proposition.


16. Trump somewhat, but not entirely limits ES cell funding. The Trump administration probably does not outright ban federal funding of embryonic stem cell research, but there may be some effort to limit it in some way such as not supporting generation of new lines perhaps à la Bush.  Grade: Thankfully, wrong. Very quiet out there.


17. Fetal tissue research restriction effort. The Trump administration and/or the GOP attempt to restrict human fetal tissue research.  Grade: Wrong, but there has been a lot of talk that this may be coming.


18. CRISPR of human embryos is blocked or limited in some way in the U.S. (e.g. FDA is not permitted to review applications related to this area as was the case with the rider on spending bill for 2016).  Grade: I believe there is still a federal restriction in place.


19. Trump creates something like Bush’s President’s Council on Bioethics. It’s packed with conservatives including someone tied to the Witherspoon Institute. Deja vu all over again.  Grade: Wrong, thankfully.


20. Florida acts on clinics. The state of Florida takes some action on stem cell clinics, which are out of control there. Things are a mess clinic wise here in California too, but I’m not so sure the state will do anything helpful to deal with it.  Grade: Wrong, but something could be coming.

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