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.

Jeong Chan Ra Reported Arrest: Can Korean Stem Cell Biotech RNL Bio (알앤엘바이오) Survive?

Dr. Jeong Chan Ra (라정찬 ),

Over at Health in the Global Village, Leigh Turner yesterday published an excellent piece updating us all on the latest news on Korean stem cell company RNL BIo (알앤엘바이오) and its leader, Dr. Jeong Chan Ra (라정찬 ).

Addition: The story was reported in several Korean news outlets including Hani here.  A video here by MBC News of Korea, one of the top 4 News outlets in Korea, also reports on the case. Of course Ra is not guilty of any of this unless proven so in court, but this sure isn’t good news.

Turner provides all the details on the reported arrest of Dr. Ra as well as the key background on RNL Bio and Ra that has led up to this situation.

Could this be the beginning of the end for RNL Bio?

I think the coming weeks or months will be crucial either way.

Turner’s piece details the numerous troubles facing Ra and RNL Bio related to a patient lawsuit and accusations of fraud, delisting from the Korean stock market, dueling lawsuits with former US partner Celltex, the deaths of some patients, and now the reported arrest of Ra for alleged insider trading. Ra is also accused of sexual harassment.

Ra’s arrest has been in the Korean news the last week, but to my knowledge Turner’s is the first English language piece providing coverage on this very important development.

I hope that if other web news outlets subsequently go forward with the story that they credit Turner for breaking it, but I wouldn’t bet on that happening.

From a broader perspective what does all this mean?

Could this ultimately sink RNL Bio?

While I wouldn’t count the company out quite yet, it is difficult to see exactly how Ra and the company might manage to bounce back.

One also has to wonder about the reverberations for Celltex here in the US.

To my knowledge the subsidiary of RNL Bio, Human Biostar Inc., still has control over most or all of the Celltex patient stem cell samples stored in liquid nitrogen in separate facility in Texas. Are those now in jeopardy? Or might these events lead to their being more expeditiously turned over to Celltex if RNL is sinking? The situation overall seems highly unstable.

From a larger view, I believe that the RNL Bio situation will lead to greater scrutiny of transport of human stem cells across international borders as well as of the conduct of companies doing stem cell business in multiple countries and marketing to foreign customers by regulatory and legal authorities.