How are things looking for the stem cell field for Spring 2011?
Issue One. Getting to the clinic.
At this point, Geron and ACT have their FDA-approved clinical trials underway using derivatives of human embryonic stem cells. As expected no news has leaked out on how things are going and it may well be Fall or even early 2012 before we hear anything on safety and who knows about efficacy. StemCells Inc has a trial underway in Switzerland for spinal cord injury (see blog post by my friend Amy). The hope is that additional Phase I or Phase I/II trials using highly stem cells will begin in the near future to address diseases and injuries that at this have few to none treatment options.
Issue Two. Funding.
First, the good news. CIRM continues to fund translational research and likely will announce potential funding for for-profits as well in 2011. As I blogged before, it turns out that CIRM is the largest funder of stem cell research in the world, but even CIRM cannot carry the field. Federal research is crucial and supports more individual research grants, which brings us to the bad news.
The bad news is that the federal budget has turned into a political ping pong ball and as a result even though fiscal year 2011 is about half over, we have no federal budget. All we have is a string of continuing resolutions (CRs) that leave the entire federal government operating in budgetary disaster mode, never sure if the government might shut down entirely. The House just passed a CR for 3 more weeks to prevent the shutdown that would otherwise occur on Friday in less than 48 hours. The Senate is predicted to approve it and Obama will sign it, but this will simply buy 3 more weeks of time. Republicans have proposed cutting the NIH budget by about 5%, which would be disastrous for science generally, but also for stem cell research. The current situation isn’t much better as NIH is operating in a very conservative mode given the unknown status of its budget and is awarding very few grants at this time. Meanwhile, stem cell research around the world continues unimpeded and every day that goes by, the U.S. loses a bit of its competitive edge. As I wrote in an op-ed piece in the Sac Bee a couple weeks ago, stem cell research funding is a critical, national security issue. You can read the article here.
Issue Three. iPS cell field hitting turbulence.
As we recently blogged, there has been a steady stream of papers identifying genomic and epigenomic alterations in iPS cells. Many of these changes are associated with cancer and together they highlight a key question: will iPS cells transcend being the most powerful tool for disease modeling ever and be used clinically? At this point, I think it is too soon to be know. Surprisingly, I don’t see this development of the identification of potential problems with iPS cells as a bad thing. Looking back a couple years, many of us predicted these issues would exist, and the sooner they were not only identified but accepted as challenges, the sooner they could be addressed. See my review on Stem Cell Tumorigenicity in Stem Cells here. The problem has been that the field has been overhyped and serious issues like iPS cell tumorigenicity were not adequately addressed up until more recently. A second critical question is whether de-differentiation/trans-differentiation of cells will ultimately prove to be a more clinically relevant approach than cellular reprogramming/iPS cells. It’s an exciting time and we’ll soon get the answers to our questions.
Issue Four. Politics and Law.
Mysteriously, the two court cases involving embryonic stem cells have been out of the news for months. It is unclear why, but most likely the judges involved needed more time to fully familiarize themselves with the huge amount of information involved in the case. Nonetheless, anyone who cares about stem cell research or who has a loved one with an illness that might be treatable using embryonic stem cells, should be under no illusions that these court cases have gone away for good. At some point, there will be verdicts and they could go against us.
Issue Five. Publications
The number of publications on stem cells and particularly iPS cells continues to grow. What I see as a healthy sign is that the number of diverse journals publishing articles on iPS cells grows as well, whereas not that long ago only a few journals published most of the iPS cell articles. The number of stem cell journals also continues to grow. I have mixed feelings on that. While in the past I saw that as a positive, I’m not so sure anymore as many of the new journals are publishing poorer quality articles. Even so, the journals will be subject to evolutionary forces and most often only strong ones will survive.