Biomedical Engineering Reference
In-Depth Information
clinical trial phase, with a product aimed at repairing spinal cord
injury (
http://www.geron.com
). Also based in the US, Advanced Cell
Technology is also now in the process of recruiting patients for two
separate clinical trials for eye conditions (
http://www.advancedcell.
com
). One is for participation in a combined Phase I and II open trial
of an hESC-derived product in Stargardt's macular dystrophy, an
inherited degenerative eye condition mainly affecting teenagers. The
other trial is very similar but for older patients with the age-related
macular degeneration condition known as dry AMD. Yet in
mid-November 2011, the Geron trial was closed to further enrolments
after the company decided to focus on cancer therapeutics instead
('News release',
http://www.geron.com
, 14 November 2011), leaving
the two Advanced Cell Technology trials the only current clinical
trials utilizing human embryonic stem cells approved by the FDA. As
discussed in Chapter 2, there are, however, plenty of reports of
clinical usages of human embryonic stem cells around the world that
have not been scientifically verified (e.g. Landau, 2011). This chapter
focuses on the development of the established clinical and commercial
outcomes from hESCs generated through the three clinical trials that
have been approved by the FDA.
5.1 The global debate
As has been well-documented, one of the biggest barriers to the
development of hESC research has been the significant global
community debate around the ethics of using human embryos in
research. By and large, the derivation of human embryonic stem cells
is deemed to be ethically and politically contentious because of
continuing debate within global communities about the role of the
human embryo. Some say that the destruction of the embryo in the
process of harvesting stem cells is ethically problematic while others
suggest that using embryos as the materials for scientific research at
all renders the human subject as an instrument to be used for the
benefit of others (Robertson, 2001; Holland et al., 2001; Walters,
2004). The patenting of biological products is also seen to be
ethically distasteful in some arenas too (Salter, 2007; Resnik, 2002).
