Every year I look into my stem cell crystal ball and make a top 10 list of stem cell predictions for the coming year.
My predictions for 2015 will be coming up soon and I may bump them up to 20 predictions instead of 10 because there’s so much going on in the field.
If you are curious, you can read my past top predictions for 2011, 2012 and 2013. You can also see how much the stem cell field has changed based on these past predictions. Generally the changes have been for the positive, which is encouraging!
Towards the end of last year, I posted my stem cell predictions for this year of 2014.
How did I do?
Below are my 10 predictions (including short blurbs I wrote about each) for stem cells for 2014 that I made about a year ago and my hopefully semi-objective assessment of whether I was right or wrong as indicated by color in each case. I got roughly eight out ten correct.
10. Academic Programs in Physician Training in Stem Cells Come Closer to Reality. In 2014, we hear about plans for the first ever academic physician training program in the US in stem cell and cellular/regenerative medicine. Such a program would be a 1-year fellowship or subspecialty program at a school of medicine or hospital. More and more doctors tell me they want such training. I’m just waiting for some institution to have the courage to be the first. What an amazing thing that’ll be. Somebody please step up!
Assessment: Right. A number of programs are in the works including this one. They are still small and experimental, but I find it heartening. I know of more in the works.
9. The “it’s a small world” globalization of stem cells accelerates for both the positive and negative. We see ties between Stamina in Italy and US players. We see that Celltex, that stem cell clinic originally from Texas, gets more heavily involved in stem cell interventions in Mexico, possibly buying an existing facility or company there such as Integrative Stem Cell Institute in Cancun. At the same time the company continues to face scrutiny from the FDA in the US. Other companies continue to do business in a number of countries. We hear more about non-compliant or even illegal exports and imports of human stem cell products. To be clear there’s nothing wrong per se with stem cell companies doing international business as long as it is for the good of patients and the field.
Assessment: Right. More and more legit and also dubious stem cell companies are going international. Stay tuned for more on this in the coming months. Globalization of stem cell and regenerative medicine can be a good thing and builds on collaborations, but many dubious operations take advantage of international operations to do harm to make money.
8. FDA prevails in US v. Regenerative Sciences appeals case and we see more stem cell-related lawsuits in 2014. I’m hearing a lot through the grapevine about conflicts that seem likely to bubble up into actual litigation. Some of this is likely to be company vs. company, while some may be patient vs. doctor, perhaps due to lack of proper training mentioned above. Others may be organizations/companies/patients vs. the FDA over regulatory issues.
Assessment: Right. However, this seemingly major victory for the FDA hasn’t really translated into more assertive action by the agency. Let’s see what develops in 2015.
7. One of the hottest trends in 2014 is organ/tissue growth from stem cells as we saw in the 2nd half of 2013 with livers, brains, kidneys and such. Some of the hottest publications in 2014 are on growth of actual organs and tissues that are functional.
Assessment: Right. Many stem cell-based organ advancements were reported this year including small intestine, liver, and others. For example, Organovo’s “Ex-Vive” Liver was hailed as the 7th top biotech development by The Scientist Magazine.
6. Cell Surgical Network and/or Stem.MD make big news. I’m guessing it won’t be something that they are happy about, but let’s see.
Assessment: Right. Cell Surgical Network was featured on the NBC Nightly News on December 5th. The report was fairly skeptical and raised numerous concerns, although it did contain one error on FDA regulation of stem cell treatments. Still, admittedly, on the regulatory front I’m not aware of any actions involving these stem cell clinic chains in 2014.
5. The stem cell biotech, California Stem Cell, will make major positive news in 2014. The company is developing stem cell therapies for cancer, spinal cord injury and other conditions. They have FDA approval already for some trial work.
Assessment: Right. They were bought by NeoStem. This was a huge deal for the Cali company.
4. CIRM hires its new President, who was someone mentioned on this blog as a candidate. A big question mark remains–will a new proposition (a la Prop 71) be launched in 2014 for more CIRM funding in the future beyond 2017?
Assessment: Wrong. Randy Mills was not mentioned as a candidate on this blog before his choice was announced. I guess nobody is perfect in their predictions, huh?
3. Big announcement from “Big Pharma” on stem cells or regenerative medicine. This could be in the form of their own research or acquisition of a smaller biotech in the stem cell arena. Any bets on takeover targets?
Assessment: Right. We saw J&J put up hundreds of millions for Capricor and more such big pharma stem cell developments this year.
2. More criminal charges filed against dubious stem cell organizations in 2014 or “legit” organizations finding themselves in hot water in the media related to stem cells. I’m hearing about quite a few investigations still ongoing. Some organizations that have “good reputations”, which may even include academic institutions or “legit” biotechs, may find themselves in hot water in the media (even if not going all the way to criminal charges) related to dabbling with non-compliants in the pursuit of easy cash (e.g. for fee for service agreements).
Assessment: Right. In Italy, a prosecutor filed indictments against many people (including a number of doctors) connected to the controversial Stamina Foundation. According to Science, the prosecutor described Davide Vannoni, who leads Stamina, as “the head of a criminal organization”. Whoa. We also in the US saw one indictment of a guy working for stem cell company Organogenesis (the company was not implicated) for allegedly stealing skin. There are quite a number of potential criminal cases percolating around under the surface related to stem cell clinics, but one never knows if they’ll poop out or turn into something important.
1. The US FDA takes at least one of two positive actions: approves its first breakthrough designation for a cellular therapy (most likely an adult stem cell-related therapy) OR approves an iPS cell-related IND. I hope both.
Assessment: Wrong. The FDA is going to do this some day, but 2014 (so far at least) wasn’t the year for it. Call me an eternal optimist, but I believe we can have our innovation in stem cell-based medicine and have it be evidence-based medicine too.