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Government Support for Stem Cell Research Evolves, Business and Industry Trends Analysis

Shortly after taking office, U.S. President Barack Obama reversed an eight-year ban on the use of federal funding for embryonic stem cell research.  Specifically, Obama issued Executive Order 13505, entitled “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells.”  This executive order, dated March 9, 2009, charged the National Institutes of Health (NIH) with issuing new guidelines for stem cell research which became effective in July 2009.  The order further authorized the NIH to “support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.”  The important words here are “human embryonic,” since the harvesting of stem cells from discarded human embryos is what started the stem cell funding controversy in the first place.  Further, this wording clearly eliminates the possibility of funding research projects involving stem cells that result from cloning.  Under previous U.S. regulations, federal research funds were granted only for work with 21 specific lines of stem cells that existed in 2001.  Harvesting and developing new embryonic lines did not qualify.

By mid-April 2009, the NIH had issued a new policy statement.  The issue of funding remains politically charged.  The NIH is taking a middle road.  Its guidelines state that embryos donated for such research must be given voluntarily and without financial inducement.  (Such embryos typically are donated by couples who have completed fertility treatments and have no need for remaining, redundant embryos.  This is a common practice in seeking laboratory-aided pregnancies.)

Once a stem cell starts to replicate, a large colony, or line, of self-replenishing cells can theoretically continue to reproduce forever.  Unfortunately, only about a dozen of the stem cell lines existing in 2001 were considered to be useful, and some scientists believe that these lines were getting tired.

The use of non-federal funding, however, was not restricted during the eight-year ban, although many groups did want to see further state or federal level restrictions on stem cell research or usage.  A major confrontation continued between American groups that advocated the potential health benefits of stem cell therapies and groups that decried the use of stem cells on ethical or religious terms.  Meanwhile, stem cell development forged ahead in other technologically advanced nations.

In November 2004, voters in California approved a unique measure that provides $3 billion in state funding for stem cell research.  Connecticut, Massachusetts and New Jersey also passed legislation that permits embryonic stem cell research.  California already has a massive biotech industry, spread about San Diego and San Francisco in particular.  As approved, California’s Proposition 71 created an oversight committee that determines how and where grants will be made, and an organization, the California Institute for Regenerative Medicine (CIRM, ), to issue bonds for funding and to manage the entire program.  The money is being invested in research over 10 years.

As of early 2018, CIRM had made 973 grants totaling more than $2.53 billion.  These grants are funding dedicated laboratory space for the culture of human embryonic stem cells (HESCs), particularly those that fall outside federal guidelines, in addition to underwriting staff positions, research models, training programs and more.

Corporate investment in stem cells has also been strong.  AstraZeneca Pharmaceuticals invested $77 million in a startup firm in San Diego called BrainCells, Inc. to study how antidepressants might be used to spur brain cell growth.  In late 2012, Osiris Therapeutics, Inc. received approval in Canada and New Zealand for the world’s first stem cell drug Prochymal, which derives cells from the bone marrow of young adults to treat acute graft versus host disease (GvHD).  Prochymal was in Phase III trials for treatment of Crohn’s disease and acute graft versus host disease (GvHD), and Phase II trials for acute myocardial infarction in early 2016.



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