Thursday, September 13, 2018

A Global Stem Cell Perspective: CIRM's Accomplishments in a Field Tougher than Rocket Science

The comments below were emailed to the California Stem Cell Report yesterday in the wake of recent news coverage of the California Institute for Regenerative Medicine (CIRM), as the state's stem cell agency is known. 

The author, who asked not to be identified, has followed the field of stem cell research worldwide since its inception. Here is the text of the remarks.
"As you know, I am usually reticent about putting in my two cents worth regarding CIRM and all the politics swirling around the subject. But the recent published items, as well as radio interviews on the subject, have made me quite uncomfortable. I was not in California when Proposition 71 came on the ballot, so I cannot speak to the hype and campaign promises made that swayed the public. But I have to take issue with some of the nonsense that has been reported as news.   
"Here are some relevant facts: 
"1. People forget that in 2004, the NIH, the major agency in the US funding biomedical research, prohibited funding most of the research needed for this field to move forward. Forget about clinical trials, even basic research was severely curtailed based on unscientific premises. This meant that while other countries could move ahead, US scientists could not step into the arena. Prop. 71 was proposed to unshackle Californian scientists so that they could compete in the research arena on a par with UK, Canada, Australia, and many other countries eager to take advantage of this new discovery.

"2. Lest people forget, the NIH rules at that time were so onerous that anything -- buildings, maintenance, and equipment -- partially or wholly funded by the federal government could not be used to conduct human embryonic stem cell research. Hence the need for CIRM to fund the building of labs, infrastructure and facilities early on. This is not an idea to mindlessly benefit academic institutions, but to allow their investigators to conduct stem cells research without using anything (buildings, equipment, personnel) paid for by federal funds. 
"3. Biomedical research is not like rocket science - it is much harder and much less predictable. Twenty years after the big push by Congress to cure Parkinsons’ Disease by building Udall Centers and mandating funding for this effort - PD is still not cured. Alzheimers Disease has been a target of the NIH for decades; just this year, they are increasing funding for this effort. Yet - no cure in sight. Add to the growing list the “War on Cancer” declared by Nixon in 1971. How much progress was made by 1981? Yet look at all the success today? The fact is that biomedical research is much harder than engineering, and we should be patient instead of whining about the slow rate of progress. It behooves the critics of CIRM to remember that success in research requires time and money. Things are just beginning to ramp up exponentially by the end of the first 10 years. 
"4. Finally, taking a world-wide view of the state of human stem cell research, CIRM has to be considered a great success. CIRM supported the first few clinical trials using human embryonic stem cell products. At the end of 2017, there were 17 clinical trials using human embryonic stem cells. Of these 11 are conducted in the US, and all 11 are initiated in California or conducted in California - this is completely due to CIRM. Of the 11 trials, 6 are directly funded by CIRM, and NONE by the NIH. So without CIRM, there will be few or no clinical trials using this new technology in this country!"
(For some of the news coverage, see here and here.)
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  1. Anonymous7:39 AM

    I fully support the investment that CIRM has made in making California the center of translational stem cell research. But we need to be factual- on August 9, 2001, George Bush announced that the NIH would fund human embryonic stem cell research. The NIH grants for this research started being funded in 2002. Two labs in California received this funding because they had made human embryonic stem cells with private funding before the cut off of August 9. NIH auditors visited these labs and made their regulations clear. As long as the human ES cells were on the government's list of approved lines (more than 20 different cell lines), there was no conflict in using them in any NIH funded laboratory. To be clear, Bush's decision was to SUPPORT hESC research with NIH funds. It was restrictive only in that any NEW hESC lines made after that date could not be researched with NIH funds. Anyone who doubts this account can read about Bush's announcement here:

  2. Re the anonymous comment concerning Bush's action, the author of the original item on Sept. 13 offered this reply.
    "Let’s shine a light on the Bush policy to be truly transparent and factual. Only research on human embryonic stem cell lines generated before his announcement in August 2001 were eligible to receive federal funding. The NIH had to scramble to identify all lines worldwide that fit that arbitrary criterion. The majority of the Bush lines were eventually found to be not available, not robust, contaminated, and in some cases not even alive. Of the few viable lines, most were were made abroad, adding an additional barrier to US scientists seeking to obtain them. Yet newly created lines made by US investigators that were better and more abundant than those on the “approved list” were not eligible according to the Bush policy. There was no scientific reason for limiting lines by an arbitrary date, and being forced to only use these approved lines could have curtailed the field tremendously. Scientists always want to use the best reagents and tools to advance their research, and in this case, the limited number of “old” lines that the Bush policy permitted truly held back the field and deterred US investigators from making progress in the field. If the government had settled for Thomas Edison’s Direct Current approach for generating electricity, and outlawed Tesla’s Alternating Current approach, we would not have the working electric grids that serve us so effectively today. By 2004, it was clear that many new and better lines were available in the US, but scientists could not get NIH funding to study them. Proposition 71 opened the door to advances in this field, unencumbered by the restrictive Bush policy."

  3. Interesting discussion, Anonymous 1 and Anonymous 2. I was one of the handful of researchers who got NIH grants to teach people how to culture hESCs..I started the courses in 2004. We used the H9 hESC line, one of the originals made in Jamie Thomson's lab in 1998.
    I think for transparency's sake, we should acknowledge that the vast majority of published papers still use H9, 20 years later, and that a CIRM funded project for spinal cord injury is using another of the 1998 lines, H1. I know that Viacyte is using a line made after the 2001 cutoff, but a lot of other groups and companies are going forward in the clinic with good old H1, H7, and H9. It's self-fulfilling...since H9 was the first line to be distributed widely and relatively easy to grow., there are more data on H9 than any other hESC line. Since there are more data available, more scientists use H9...hence the growth in popularity. Also, several of the 7 labs who ran the NIH hESC courses used H9, so the next generation of stem cell scientists started their labs with that line.
    There are more than 300 hESC lines now available for NIH funding, and I would bet that no more than a handful have been used in labs, and that H9 is still the most popular.
    Anonymous 2, you must be one of us- those who went through NIH vetting before Prop 71 passed - and knew that we could use them in our own labs.

  4. Comment from CIRM's Geoff Lomax, who handles strategic initiatives for the agency.
    "It's 2001 all over again. Note that NIH's latest call for clinical trial applications includes a prohibition on "Clinical trials using human embryonic stem cells or cells derived from embryonic stem cells." I am proud to be part of an organization that has provided stability to a field that is working aggressively to address patients’ needs with all therapeutic options on the table."

    Lomax reported some difficulty in posting his comment, so we are relaying it. It you have problems posting a comment, please send it along to, and I will post them on your behalf. Cause of the issue with Lomax is unknown. Thanks to all.