Each year I make predictions for the stem cell field for the coming year. In today’s post I write about my top 10 stem cell predictions for 2014.
You can see my predictions for 2013 here (see predictions for 2011 and 2012 predictions, which are kind of fun to read to see what was on the “mind” of the field in past years). and how I did on my 2013 predictions here.
As usual the predictions are a mixture of good and bad news.
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!
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.
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.
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.
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.
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.
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?
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?
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).
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.
As usual some predictions are riskier than others and some are based on insider info, while others are based on hope for the field more than anything else.
Disclosures. The above 10 predictions are just my guesses and opinions–not statements that should be taken as fact or used as the basis for financial or medical decisions.