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.

At mid-year, how are my top 20 stem cell predictions for 2015 doing?

Stem Cell PredictionsEach year towards the end of December I make predictions for the coming year as I did for 2015. In the past I usually make a top 10 prediction list, but for this year I made 20 predictions. Admittedly some of them may have been more hopes than predictions.

At mid-year today on June 30th, how am I doing? See below. Note that of course for some the jury is still out.

BTW, stay tuned for more on an upcoming update on the Japan IPSC macular degeneration trial where there seems to have been a (hopefully minor) hitch.

  • FDA ‘breakthrough’ on stem cells. FDA grants an investigational stem cell biological drug therapy the breakthrough status designation. Status: so far no luck, but still hoping.
  • Adult & pluripotent stem cell advances both impress. More encouraging publications and news on the clinical and translational fronts for both pluripotent and adult stem cell drug development including MSCs. Status: Definitely correct.
  • Doc training in stem cells. More new academic-related training programs for doctors to be true stem cell and regenerative medicine specialists. Status: so far no luck, but still hoping.
  • Big pharma’s big interest in stem cells grows further. Big pharma’s interest in stem cells & regenerative medicine continues to grow including at least one major development that might be takeover of a stem cell biotech or something else. That are some small stem cell biotechs that seem ripe as takeover targets. Status: Mixed bag. Both some positive and some negative signs on this.
  • RTT spread. At least one more state (and probably more) pass Right To Try (RTT) laws setting up a collision course between state and federal laws on investigational drugs including stem cell products. Status: Definitely correct. Tons of states moving on RTT.
  • Pro sports gets a bit more serious about dubious stem cell “treatments”. A pro sport players association or league acknowledges growing and difficult stem cell issues for players. Status: Mixed bag. 
  • More high-profile stem cell paper problems. At least one and probably more major stem cell paper problems pop up and could include retractions. Status: Yes, unfortunately (just see Retraction Watch on stem cells)
  • The UK Parliament OKs 3-parent baby tech. The parliament approves 3-parent/mitochondrial transfer technology, but more steps are required before it is practiced in humans. Status: Correct
  • Stem cell clinic chains Cell Surgical Network and Stem.md continue to grow for at least the first half of 2015 and probably beyond. They operationally challenge recent FDA draft guidances on adipose and minimal manipulation. Status: Correct
  • STAP-related news on the American front. We learn something on the US side of the story of the retracted STAP cell Nature papers. Status: Not yet, but stay tuned.
  • Muddier stem cell waters. More mixing of “legit” stem cell companies and researchers with the non-compliant side of the tracks. Status: Unfortunately correct
  • More stem cell paper debates and developments on PubPeer. A volatile situation continues with notable twists and turns. Status: Yep.
  • IPSC RPE safety. The IPSC-based RPE trial for wet AMD in Japan continues in 2015 without a reported safety hitch. Status: Probably Wrong (again stay tuned, but don’t freak out).
  • A stem cell biotech finds itself in a hairy situation. What a tangle. Status: stay tuned.
  • At least one patient is harmed or files suit for a dubious stem cell clinic treatment. This is a sad prediction, but unfortunately I think it is likely. Status: publicly not yet.
  • VSEL hell. There will be even more bad news for these Sasquatch of stem cells after the Weissman lab paper that seemed to refute these “very small embryonic-like” stem cells in 2013. What does this mean for NeoStem ($NBS) now known as Caladrius? Status: Nothing public yet, but I still expect it to be a bad year for VSELs. For Caladrius, I’m thinking the impact is minimal since their focus seems elsewhere under new leadership.
  • Celltex is going for an IND. This is an interesting development. Status: not publicly.
  • GOP on stem cells. Republications make some noise on stem cells or personhood. Status: not yet, but they are on CRISPR as my old soccer coach would say when I was a kid “like a duck on a june bug”.
  • FDA back in the game of taking action on dubious stem cell clinics. After a long quiet period in 2014, the FDA takes some action on dubious stem cell clinics. Status: depressingly, not yet.
  • Stem cell-based organs. The red-hot trend of bioengineering organs and tissues in part using stem cells as a material continues to develop. Status: Yes, organs and organoids are one of the hottest trends of 2015.

J&J Bets Up to $325 million on Capricor: Big Pharma Stem Cell Move as Predicted for 2014

linda marban CapricorBig Pharma Giant Johnson & Johnson (J & J; $JNJ) announced today a $12.5 million investment in stem cells & regenerative medicine via the small biotech Capricor ($CAPR) and the potential for the bet to go into the hundreds of millions for the heart disease program.

It was only 8 days ago that I made my stem cell predictions for 2014 and #3 on the list was “Big announcement  from “Big Pharma” on stem cells or regenerative medicine.”

Chalk that up for the crystal ball of this blog at one for one so far for 2014.

According to the FierceBiotech today:

Later this week a little biotech named Capricor Therapeutics is set to begin a Phase II study of its new stem cell therapy with about $20 million in support from the California Institute for Regenerative Medicine (CIRM).

J&J’s role could shoot up to over $300 million depending on how things go.

I’d call that big money. Investors seem enthused as well as the CAPR stock is up nearly 50% today at the close.

The Capricor adult stem cell product is CAP-1002, which is in clinical trial and consists of allogeneic cardiosphere-derived cells. The trial may enroll up to 274 patients, which is impressive.

FierceBiotech quotes Capricor CEO Linda Marban (pictured above) as follows:

“One of the reasons why I was motivated to work on this deal is because of the statement it makes in the field,” says the CEO. “It says, OK, somebody very large and powerful is taking a look at this technology and saying there’s something there, and that’s the most exciting thing for me.”

I’ll be very curious to see what else big pharma might have in store on the stem cell/regenerative medicine front.

Disclosure: To my knowledge, I have no financial interests in the companies discussed in this piece.