√ 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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√ Midterm Grades On My Top 20 X 2018 Stem Cell Predictions

Every year in December I go out onto a limb and make stem cell predictions for the coming year as I did in late 2017 for this year. Then usually around the 1/2-way point through the year I check in on how the predictions are faring so far at that point.

In this post I give my 2018 predictions (pasted below) the 1/2-way point checkup. Things are off to a reasonably strong start for the old stem cell crystal ball.  For the grading, green is already accurate and orange is either “not yet” or “not clear enough yet”.

What are your predictions for 2018? How about 2019 predictions? For next year, I’ll publish my attempt at being a stem cell oracle in about 5 months.

1. Combo cell-gene therapy continues hot, but with both ups and downs. Combination cell-gene therapy makes more big news including probably additional FDA RMATs here and possibly 1 more drug approval. Some of this could be CAR-T stuff, but probably other work too in this area such as 2017’s epidermal regeneration. Hopefully more ups than downs. Checkup: Yes. Very hot in 2018 and unfortunately the prediction was right about there being downs too as FDA has put a hold on a key CRISPR Therapeutics trial.


2. At least 20 total FDA RMATs. The FDA continues issuing a steady stream of RMATs getting to a total of 20 or probably more (including those issued in 2017.) Does a dubious stem cell clinic-related biz get one in 2018? Possibly, but if so, I’d bet no more than one such firm and it has an IND first. Checkup: Yes as I’m told that FDA leadership announced at a meeting the 20 RMAT mark this month just days ago. My RMAT list is regulated updated and stands at 19 in the public domain.


3. More IPSC movement in Japan. More IPS cell regenerative medicine progress in Japan including 1 new clinical trial/study beyond Masayo Takahashi’s work. Checkup: Yes. See this post on a new heart study and the debate over whether the Japanese regenerative medicine oversight system is too lax.


4. IPSC step forward in USA too. A major step forward for IPS cell clinical trial efforts in the U.S., probably at least 1 notable IND. Checkup: Not yet.


5. In utero experimental interventions make news. There is a lot of interest in having impact on developing fetuses during pregnancy including via stem cells. At least 1 high-profile study or news development. Checkup: Yes, see the big news here.


6. ESCR in USA funding stays OK. Assuming Trump is still president throughout 2018 and not Pence, we do not see any concrete restrictions (no new federal law or Presidential action) on embryonic stem cell research (ESCR) in the U.S. Trump just doesn’t personally care about it and Pence has little influence on social issues with him. Checkup: So far, yes!


7. CRISPR human embryo news. More big new CRISPR human embryo news and/or pubs including at least 1 more “knockout” paper in viable human embryos, probably from Fredrik Lanner’s lab (see interview here). More from Kathy Niakan? See my review of her CRISPR OCT4 knockout human embryo work here. Checkup: Not yet. I’m kind of surprised given the momentum last year.


8. Parkinson’s Disease advance. A major step forward on stem cell-based therapies for PD, possibly including 1 IND. Checkup: Not yet, but Lorenz Studer’s ISSCR 2018 talk suggests a major PD step forward is coming soon.


9. Dubious clinics’ MSM ads continue to flow. The demam isu of mainstream media ads for stem cell clinics continues in a big way. Anyone seen TV commercials yet? Checkup: Yes, unfortunately. Someone even said they saw stem cell commercials on TV.


10. Ma, et al. human embryo CRISPR pub arguments: limbo at best. The main conclusions of that Mitalipov lab Ma Nature paper on interhomologue repair in human embryos with CRISPR are not conclusively confirmed. They remain at best in limbo throughout most or all of 2018. Checkup: So far, yes. Strangely so far Nature has not published the Egli, et al. matters arising piece…or I missed it.


11. Clearer CIRM path to 2020 effort. CIRM supporters firm up plans for a new California state proposition effort for 2020, which probably includes a continued plan for an initiative for more funding. Checkup: Getting some hints, but I’ll score this as not quite yet as there’s not that much clarity.


12. At least one state steps up on dubious clinics. At least one state takes legal action on stem cell clinics in its borders. This could be a medical board or some other state governmental body. Checkup: Yes, see this post on North Dakota! More to come I think.


13. Some unusual FDA action on dubious clinics. The FDA issues more than 1 warning letter to dubious stem cell clinics and/or takes some other bold action in 2018 such as an injunction or some other strong step that clearly breaks with what it’s done in the past. Checkup: Yes, big time with 2 big suits via the DOJ.


14. Other Feds step in too. Some other federal body takes an interest in dubious stem cell clinics. Checkup: Not yet, but still possible.


15. More patients sue. One or more new patient lawsuits against direct-to-consumer stem cell clinics. Checkup: Yes, more suits.


16. Clinic strikes back, threatens suit. At least one clinic selling non-FDA approved stem cells threatens to (or does) sue a regulator, a patient, or other critic. We saw one such threat in the news in 2017 and there were more behind the scenes too in 2017 too. Checkup: Nope, not that I know of.


17. Florida stem cell hot mess. The stem cell mess in Florida continues to heat up. Even though California has more clinics, Florida probably makes more news with problems. Checkup: Yes.


18. Clinic leaks. An insider at a direct-to-consumer stem cell clinic leaks information or documents that aren’t flattering for the biz, or somehow such isu comes to light, perhaps via a lawsuit. Checkup: Not yet.


19. A biotech gets a boost, but the bummer is that overall stem cell biotech stocks continue to struggle. As to the former, a well-known stem cell-related biotech is either acquired or has an IPO. Checkup: Mixed bag, stay tuned.


20. Anti-aging efforts spark more news and controversy. This could be young blood, specific anti-aging stem cell-related factors, and/or actual stem cells. Checkup: Yes. See here for example.

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