The Endless hESC Controversy in the United States: History, Context, and Prospects

Gottweis, Herbert

doi:10.1016/j.stem.2010.10.008

Cited by 15 publications

(14 citation statements)

References 4 publications

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“…In the United States, controversy over hESC research dates to the seminal 1973 United States Supreme Court decision on abortion rights, Roe v. Wade. During the Reagan and Bush administration, funding was not available for research involving human embryos, which culminated in the 1995 Dickey-Wicker amendment that banned federal funding of human embryonic research [ 28 ]. The second Bush administration in 2001 went on to ban federal funding (primarily National Institutes of Health (NIH)) that had been allowed under the Clinton administration.…”

Section: Background: Hesc Research In the United States Sweden And mentioning

confidence: 99%

Stepping Into and Out of the Void: Funding Dynamics of Human Embryonic Stem Cell Research in California, Sweden, and South Korea

Weinryb

Bubela

2015

Stem Cell Rev and Rep

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Nonprofit organizations and philanthropists stepped into a funding void caused by controversies over public funding of human embryonic stem cell (hESC) research. Based on interviews of 83 representatives of 53 funders, we examine the motivations and accountability structures of public agencies, corporations, fundraising dependent nonprofit organizations and philanthropic organizations that funded hESC research in three jurisdictions: California, Sweden, and South Korea. While non-traditional forms of funding are essential in the early stages of research advancement, they are unreliable for the long timeframes necessary to advance cell therapies. Such funding sources may enter the field based on high expectations, but may exit just as rapidly based on disappointing rates of progress.

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Section: Background: Hesc Research In the United States Sweden And mentioning

confidence: 99%

Stepping Into and Out of the Void: Funding Dynamics of Human Embryonic Stem Cell Research in California, Sweden, and South Korea

Weinryb

Bubela

2015

Stem Cell Rev and Rep

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“…The plaintiffs stated they would review their options for appeal, but it is uncertain whether it will go any further 56,57 . Regardless of the decision, Congress would need to repeal the Dickey‐Wicker Amendment in order to remove definitively any potential legal obstacles to government‐funded hES research 58 . However, many remain skeptical the Dickey‐Wicker Amendment will be repealed and wonder about renewed vulnerability under future political administrations 59 .…”

Section: Political and Legal Controversy In The United Statesmentioning

confidence: 99%

“…Though recognizing a long road of maturation with many unknowns and inherent problems, some speculate that this embryo‐independent stem cell technology has the potential to replace many, if not all, pluripotent stem cell applications 96–99 . However, while iPS does address many issues pertaining to resource availability, genetic diversity, and concerns regarding embryo destruction, many in the scientific community call attention to the fact that iPS is yet insufficient to meet all the challenges faced by hES 58 , 97,98,100–102 …”

Section: Putting It All Together: Impedance and The Future Of Stem Cellsmentioning

confidence: 99%

Impedance of Novel Therapeutic Technologies: The Case of Stem Cells

Zacharias

Nelson

Mueller

et al. 2012

Clinical Translational Sci

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Human embryonic stem (hES) cell technology has advanced for more than a decade and has come to be regarded as "the gold standard" in the stem cell fi eld.1,2 Th ese cells have met the most stringent standards for pluripotency and demonstrate immense promise for diagnostic and therapeutic capabilities.3 Nevertheless, hES research has given rise to social confl ict and nations remain divided regarding its regulation. 4 We aim to distinguish between the scientifi c and clinical realities of hES technology and highlight the ethical, legal, and social issues concerning its use in the United States (US). In light of obstacles that impede the progression of these technologies, we consider what the future may look like for stem cell research. Scientifi c and Clinical Applications of hES CellsSince isolation in 1981, nonhuman embryonic stem (ES) cells have proven suffi cient to give rise to all tissues of the adult organism across all three embryological germ layers.5-8 Twenty-seven years later in 1998, the fi rst hES cells were isolated from frozen embryos and have since contributed enormously to our understanding of cellular pluripotency. 3 , 9 Although no hES treatments are available for clinical use in nonstudy settings in the US, the fi rst FDA-approved Phase I clinical trials for hES technology are underway assessing the safety of hES cell-derived oligodendrocyte progenitor cells in patients with spinal cord injury and retinal pigmented epithelial cells in patients with age-related macular degeneration and Stargardt's macular dystrophy.10-14 Despite these advances, several practical contstraints impede translation of hES technology into clinical practice.Because of the plasticity and unrestricted growth potential of hES cells, one major concern of using transplanted hES cells in humans is the risk for teratoma formation and tumorigenesis, a challenge faced by all pluripotent stem cell platforms. [15][16][17] As recently reviewed, a number of animal studies have shown an increased risk for tumor formation arising from transplanted hES cells.18 Clearly, such an adverse eff ect must be addressed before hES technology can be off ered as an approved therapeutic product. Another risk inherent to allogeneic stem cell transplants is immune rejection. 19,20 Because hES cells are not "self " tissue, recipients would require immunosuppressive therapy similar to a patient receiving an organ transplant. For example, the Geron Phase I clinical trial stipulates that patients undergoing allogeneic hES cell transplants must receive immunosuppressive therapy for at least 4 months and be monitored for 15 years thereaft er to evaluate for rejection. 21Another concern for hES technology is resource availability. Given the absence of FDA-approved treatments based on hES cells, this topic has yet to be fully addressed. But as the research now shift s from the laboratory to the clinic in hopes of curing hundreds of diseases that aff ect millions of people, we will need to assess practically whether embryos derived from in vitro fertiliza...

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“…The isolation of human embryonic stem cells (hESCs) in 1998 intensified discussions about ethical issues associated with stem cell research and inspired a still-ongoing global policy debate over the acceptability of and funding for various types of stem cell research (Gottweis, 2010). In the U.S., three distinct federal funding policies-corresponding to the Clinton, Bush, and Obama Administrations-have been adopted (Gottweis, 2010), and the policy environment has been further complicated by uncertainty associated with congressional action and litigation (Levine, 2011).…”

Section: Introductionmentioning

confidence: 99%

“…In the U.S., three distinct federal funding policies-corresponding to the Clinton, Bush, and Obama Administrations-have been adopted (Gottweis, 2010), and the policy environment has been further complicated by uncertainty associated with congressional action and litigation (Levine, 2011).…”

Section: Introductionmentioning

confidence: 99%

Assessing State Stem Cell Programs in the United States: How Has State Funding Affected Publication Trends?

et al. 2015

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The Endless hESC Controversy in the United States: History, Context, and Prospects

Cited by 15 publications

References 4 publications

Stepping Into and Out of the Void: Funding Dynamics of Human Embryonic Stem Cell Research in California, Sweden, and South Korea

Stepping Into and Out of the Void: Funding Dynamics of Human Embryonic Stem Cell Research in California, Sweden, and South Korea

Impedance of Novel Therapeutic Technologies: The Case of Stem Cells

Assessing State Stem Cell Programs in the United States: How Has State Funding Affected Publication Trends?

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