It has been an eventful year so far for the stem cell field. Where do we go from here ? What are the key questions that face the field? Below are my top 10 questions for the field, NOT listed in any particular order, and some predictions.
1) How will Geron’s Phase I Clinical Trial go? Will GRNOPC1 be safe? When will we know? Barring any major catastrophic events, it may be a year before we find out how the trial is going. Time intervals between patients and the relatively long latency of teratoma make this a slower process than all of the impatient watchers would like, but that’s just the way it goes. The pre-clinical data on 2000 rodents support the notion that this is a safe therapy so while we cannot be sure how things will go in a human context, we can be cautiously hopeful. I think the odds are better than 50-50 it will be safe, but we’ll see.
2) What will happen with other potential Phase I ESC-based Trials? When will ACT’s trial get the green light? I think we will see at least one more trial begin in early-mid 2011, most likely ACT’s.
3) Where do we stand with IPS cells? I think the IPS cell field continues to surprise in a good way. We are closer (relatively speaking) to the clinic than I ever would have imagined at this point, but still years off.
4) Is the new RNA-based IPS method going to be consistently as good as it seems on first glance? My guess would be that the new RNA-based approach will not be as efficient in most researchers’ hands as was reported in the recent paper simply because those guys who published it are the experts at it and have been working on it for a long time. However, I think the RNA approach may very well ultimately win the day as the best.
5) What are the hurdles still ahead for IPS cells? I’d like to see more studies of IPS cell safety and tumorigenicity. Are they more prone, even when made with RNAs, to form malignant tumors than ESC? Do they form teratoma more readily than ESC? We just do not know this stuff, but it’s crucial. I think even non-genetic methods of making IPS cells may yield cells that are more tumorigenic than ESC.
6) What will be the next big advance in adult stem cell research/therapeutics? It’s hard to predict, but there will be some exciting developments in the next year for sure. But on the down side, it may be that it will become clearer in the coming year that unlike ESC, adult stem cells just do not possess the ability to grow actual organs and tissues.
7) What will happen with the pending court cases before Judge Lamberth and the DC Appeals Court? My prediction is that the ultimate ruling on this case will be given by the Appeals Court. Lamberth, if he rules, will rule against ES cell research, but he may stay his own ruling, and if he doesn’t the DC Appeals Court will do so and take over. How will the Appeals Court rule? I don’t know, but I’ll be an optimist and say in favor of ES cell research.
8) Will Congress pass a bill dealing with the D-W amendment and codify the legality of federal funding for ES cell research? No.
9) What will be the outcome, from a stem cell research perspective, of the 2010 midterm elections? As I blogged before, I think it will be really bad. Republicans will control the House, but I’m hopeful not the Senate. We’ll have more Republican Guvs who will stir up trouble in 2011. NIH and the FDA may find themselves under a harsh magnifying glass (like one in held out in the Sun) of Extremist Freshman Congresspeople.
10) Biggest surprise in the coming year for stem cells? I think someone will publish a method of reprogramming that is fundamentally different than what we’ve seen so far.