Major Step Forward for Ethical Stem Cell Research

A major New England biotech company recently announced that it would begin the process that it hopes will result in the first clinical trial using induced pluripotent stem cells (iPSCs).

This is hardly surprising, as the discovery, by Shinya Yamanaka, of the process to produce embryonic-like, fully pluripotent stem cells from ordinary somatic (body) cells has completely transformed the field of regenerative medicine (the transformative nature of Yamanaka’s work is underlined by its earning him the 2012 Nobel Prize for Medicine).

Research utilizing iPSCs has now become central to this field of medicine.

But what made the announcement especially noteworthy was that the biotech company was Massachusetts-based Advanced Cell Technology – a company that has been a leading advocate of human embryonic stem cell research (hESCR) ever since such cells were first isolated in 1998.

At one of the earliest congressional panels held to address the issue of hESCR,[1] then-ACT president Michael West not only advocated for such research, but went further and endorsed Somatic Cell Nuclear Transfer (SCNT), or human cloning to produce cloned embryos as a source of stem cells.  “[N]uclear transfer and human embryonic stem cell technology offer novel pathways to develop lifesaving therapies that will impact the lives of millions suffering from such diseases as Parkinson’s disease, diabetes, arthritis, heart disease, kidney failure, spinal cord injury, liver failure, skin burns, [and] blood cell cancers, to name only a few,” West told a Senate subcommittee.

At another hearing, West characterized hESCs as being among the gifts “that mankind occasionally is given…that can greatly advance the human condition.”[2]

ACT is also one of the two U.S. companies to undertake clinical trials using hESCs.  The first to do so, Geron (founded by West), received approval for a clinical trial using hESCs to treat spinal cord injury in January, 2010, with the trial actually beginning in October, 2011.  Geron subsequently canceled the trial, citing financial difficulties, but others saw the reason as problems inherent to hESCs themselves.

In 2011, ACT began two clinical trials using hESCs to treat two different forms of macular degeneration.  Those trials are ongoing, and any attempt to judge their efficacy is premature.

That such a major supporter of hESCR and SCNT is now putting its resources toward achieving a clinical trial using iPSCs is the latest development in a trend, noted previously on this website, towards a rethinking by proponents of hESCR of the therapeutic efficacy of non-hESCR methods.

University of Wisconsin Prof. James Thomson, who is credited with both first isolating hESCs and developing iPSCs (in research separate from Yamanaka’s), said at the time the iPSC breakthrough was announced that “the world had changed” and “over time, these [induced pluripotent stem] cells will be used in more and more labs.  And human embryo stem cell research will be abandoned by more and more labs.”

Shortly after the creation of iPSCs was announced, Ian Wilmut, the Scottish cloning pioneer who cloned “Dolly the Sheep,” announced he was abandoning cloning, as the iPSC “technique to change cells from a patient directly into stem cells without making an embryo has got so much more potential” than cloning to obtain stem cells.

The California Institute of Medicine, one of the world’s largest funders of stem cell research, has more and more over the years been moving away from its initial mission to give priority funding to hESCR toward substantial funding for non-hESCR approaches.

The University of Massachusetts Stem Cell Bank, established in 2007 as one of the nation’s premier facilities for storing hESC lines, closed in 2012, having become “obsolete.”

And now ACT, one of the nation’s leading advocates of hESCR and SCNT, is hoping to be the first to achieve a clinical trial using non-embryonic iPSCs.

It appears Thomson’s prediction is coming true.

 Gene Tarne is a Senior Analyst at Charlotte Lozier Institute.

[1] Testimony before the Senate Committee on Appropriations, Subcommittee on Labor, Health and Human Services and Education, 12/2/98

[2] Testimony before the Senate Committee on Appropriations, Subcommittee on Labor, Health and Human Services and Education,8/1/01