Follow the Money...

As this blog has previously reported (here, here, and here), the California Institute for Regenerative Medicine (CIRM) has over the years been steadily moving away from its founding mission of giving funding priority to human embryonic stem cell research (hESCR).  Instead, since 2009 it updated its strategic plan to give priority to funding projects most likely to result in clinical trials; accordingly CIRM  has been providing ever larger amounts of funding to adult stem cell and other ethically non-contentious research alternatives to hESCR.

CIRM’s most recent round of research grants, the Early Translational IV Research Awards, again confirms this trend.  According to CIRM, “the Early Translational Research Initiative aims to fund and advance potentially transformative stem cell therapies towards IND [Investigational New Drug]-enabling preclinical and clinical development.” 

In the fourth round of grants under this Initiative, announced in late August, only two of the thirteen grants awarded were for projects using hESCs, while 10 grants were for research using adult, induced pluripoternt stem cells (iPSCs) and other non-embryonic stem cell approaches.[1]  Of the total $40.6 million in grants awarded, projects using ethically non-contentious alternatives to hESR received $34.1 million; research using human embryonic stem cells received $6.4 million. 

A look at previous grants under the Early Translational Research Awards category clearly confirms CIRM’s developing preference for non-embryonic stem cell research as the best path leading to actual clinical trials.

The first round of such grants came in 2009.  Fifteen grants were awarded; nine for hESCR (three of which also included iPSCs) with the remaining six going to research using adult and/or induced pluripotent stem cells.

With the second round of Early Translational grants in 2010 a clear preference for funding non-hESCR emerges.  The number of funded projects using adult or induced pluripotent stem cells doubled from the previous year to 12, while only five projects were funded using hESCs.

In 2012, a third round of Early Translational grants was awarded.  Fifteen, or just over 70% of the 21 total grants awarded went to adult and induced pluripotent stem cell research; the remaining 6 grants went to hESCR projects. 

In the 2013 round of grants, the percentage of those going to non-hESCR increased to 77%.  The number of grants given to hESCR in 2013 fell to just 15% of the total, the lowest percentage since the first round of Translational grants in 2009, when hESCR received 60% of total grants awarded.

The old Watergate-era adage advises that one should “follow the money” to really get to the truth of the matter.   

In the case of CIRM’s research grants over the past several years, the truth is that when you follow the money, you find yet more evidence that the future of regenerative medicine is with iPSCs, adult stem cells and other ethically non-contentious alternatives to human embryonic stem cell research.

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[1] The remaining grant was for research on cancer stem cell lines.

Watch What I Do...

With its most recent round of grants – the first for 2013 – the California Institute for Regenerative Medicine (CIRM) continues its transformation from being one of the world’s leading funders of human embryonic stem cell research (hESCR) to one that increasingly supports non-embryonic research alternatives.

In March, CIRM awarded $32 million under three categories of awards.  No funding went to hESCR.  Instead, all of the funding was awarded to programs to promote research using induced pluripotent stem cells (iPSCs).

A grant of $16 million was given to a program to produce 9,000 iPSC lines for use in research on various diseases.  This is in vivid contrast to a previous round of grants, in 2008, also to generate stem cell lines for research.  Then, 16 projects were selected for funding: eight projects were for generating hESCs (5 of these projects also involved iPSCs) while the other eight were for projects involving iPSCs alone.   Now, with this current round of grants, it appears CIRM no longer sees any value in the creation of new hESC lines.

Something similar occurs with another of the March grants, a $10 million award to create a bank to store, grow and make available iPSC lines to researchers. That CIRM has not done the same to establish a bank to house hESC lines would seem, again, to indicate that CIRM finds little value in doing so.  Indeed, as noted in a previous blog, one of the nation’s leading embryonic stem cell banks, the University of Massachusetts Stem Cell Bank, closed its doors in 2012, just four years after its creation was approved.  According to news reports, it had become “obsolete.” 

The remaining grant money was dispersed among 7 projects to produce disease specific iPSC lines.  This is an area where iPSCs have clearly proved their utility in helping to develop therapies, while regular adult stem cells are far ahead in terms of direct clinical use in patients.  Producing iPSCs from cells donated from a patient (a patient with diabetes, Parkinson’s or heart disease, for example) allows scientists to observe the origin and growth of that particular disease and to test drugs to treat it.

There is the old saying “Watch What I Do, Not What I Say.”

Proponents of hESCR can still talk a good game on the supposed ongoing “need” for hESCR.

But when it comes to actually doing the research that has the goal of producing cures and therapies, more and more researchers and institutions, such as CIRM, are turning to induced pluripotent and adult stem cell research and other non-embryonic alternatives.

 After all, talk is cheap, but research costs money and its supporters want results.

Continuing to Ignore Their Own Advice -- Despite Continued Advances

A study in the current issue of  Stem Cells Translational Medicine reports the use of  neural stem cells derived from induced pluripotent stem cells (iPScs) to treat amyotrophic lateral sclerosis (ALS, also known as “Lou Gehrig’s Disease”) in rats.  The study shows that the iPSc-derived neural cells were able to engraft, survive and develop into mature neural cells in the spinal cords of the ALS rats.

Dr. Roland Pochet of the Universite Libre de Bruxelles in Belgium, who headed up the research teams, said the results “demonstrate proof-of-principle of survival and differentiation of human iPSc-derived neural progenitors in in vivo ALS environment, offering perspectives for the use of iPSc-based therapy in ALS."

Dr. Anthony Atala, editor of the journal in which the study appeared, called the results “encouraging,” adding that beyond ALS they “suggest the potential of cell therapy for the field of neurobiology and disease treatment."

The announcement of the study’s results also noted that neural cells had previously been derived from neural stem cells (NSCs) and embryonic stem cells (ESCs) as well.

But this development again demonstrates that along with adult stem cells, iPScs are proving to be viable, ethically non-contentious alternatives to the use of human embryonic stem cells; in this instance the adult and iPSc-derived neural cells did everything the hESCs did, but without having to destroy an embryo in the process.   Indeed this and other studies show the continued pursuit of hESCR is ethically unjustified even by standards first set by its proponents.

In 1999, Presidents Clinton’s National Bioethics commission (NBAC) first recommended federal funding for hESCR.  The supposed potential of the research deserved federal support, NBAC argued -- but on condition.  Given the inherent ethical problems, NBAC judged it was “justifiable only if no less morally problematic alternatives are available for advancing the research (at pg. 53).”  In others words, if viable, ethically non-contentious means existed for advancing such research and pursuing cures, then hESCR should not be pursued at all.

Induced pluripotent stem cells are already replacing the use of hESCs in several areas of research in the filed of regenerative medicine, such as in disease modeling and drug testing.   As noted in a previous blog, the California Institute of Regenerative Medicine, established to give priority funding to hESCR, has over the years been shifting more and more resources into adult stem cell and iPSC research.

Given these developments and others like it, one wonders: why do proponents of hESCR continue to ignore the very standards they set down in the 1999 NBAC report for pursuing it?