Below are my predictions for the stem cell field for 2013. I’m taking some more risks this year, but you only live once, right?
10. At least two new lawsuits are filed against stem cell businesses, most likely by patients. I think the number is more likely to be 3-4, but let’s see what develops.
9. No human iPS cell clinical trials start in 2013. More likely to begin in 2014, which will be exciting. I think this is actually good news compared to moving too fast.
8. Transdifferentiation makes a major advance.
7. A controversy emerges related to anti-embryonic stem cell research folks. For example, something pops up related to 2013 Vatican stem cell meeting or pro-life stem cell folks being tied to the for-profit adult stem cell industry.
6. Celltex moves part of its business to Mexico or another overseas location. This move may manifest in them routinely shipping patients’ stem cells out of the U.S. to be transplanted by doctors into patients in other countries. A big question is whether any transplants of Celltex stem cells will take place at all in the U.S.
5. A surprising development occurs related to another state stem cell agency other than CIRM.
4. Some clinically relevant and meaningful pre-clinical data are published on transplants of human iPS cells that is encouraging for potential future clinical safety or efficacy.
3. ACT’s clinical trials for multiple forms of macular degeneration continue without any major hiccups. Safety well-established, the focus turns to efficacy looking to 2014. The stock PPS? I won’t hazard a guess.
2. More FDA regulatory actions take place versus unlicensed stem cell companies in 2013 compared to an already increased number in 2012 and also additional indictments filed against stem cell bad actors.
1. The Supreme Court takes a pass on Sherley v. Sebelius, leaving federal funding of human ES cell research firmly in the “legal” category.