Using research and methodology developed by UC Irvine’s Hans Keirstead, California-based stem-cell research company Geron will be the world’s first to conduct clinical trials on people using human embryonic stem cells following federal government approval earlier this month in a procedure that will attempt to treat acute spinal-cord injuries.
Keirstead gained international attention in 2006 when his lab published results showing the successful use of stem cells to repair damage in the cellular sheath protecting spinal nerves in mice. The procedure induces stem cells ‘mdash; capable of transforming into any cell type ‘mdash; to become those that reconstruct the sheath protecting spinal nerves. Without this protective coating, electrical impulses fail to complete their path, leaving victims paralyzed below their injury.
Less than a dozen paralyzed subjects will participate in Geron’s nationwide trials, receiving treatment’ seven to 14 days after injury, the period deemed suitable for the procedure, according to Keirstead’s studies.
Evan Snyder, a professor at the Burnham Institute for Medical Research, said in an online forum that this trial will monitor several possible side effects, such as the emergence of cell types inappropriate to the nervous system like muscle or bone cells, the overgrowth of transplanted cells causing tumors and compression of nerve fibers that could instead inhibit function in patients.
‘Until there is some data from this study it won’t have much impact on current research,’ said Larry Goldstein, director of stem-cell research at UCSD. ‘We won’t know for some time. … It is a shot in the arm for the field but this is still a phase-one trial.’
Approval for the trial came just after the inauguration of President Barack Obama, who co-sponsored the Stem Cell Research Enhancement Act of 2007 and promised to repeal former President George W. Bush’s moratorium on federal funding for studies using embryonic stem-cell lines, or batches, derived from embryos after August 9, 2001.
‘Many of our best investigations [at UCSD] have federal funding and they’ve been very limited on which stem-cell lines they can use,’ Goldstein said. ‘Studies that receive private funds with nonfederally approved lines have been limited because equipment has been federally funded. We have to forgo the use of that equipment in those investigations.’
In California, private donations and funding made available by 2004’s passage of Proposition 71, which made $3 billion available for the development of human embryonic stem cells, have supported much of the research being conducted, including Keirstead’s and a portion of UCSD’s stem-cell research.
Worldwide, 10 labs obtained stem-cell lines prior to Bush’s announcement, falling safely within the allowed guidelines for federal funding.
Geron’s trial would be eligible for federal funding regardless of the policy’s reversal as it uses one of the federally approved lines, and both Geron CEO, Thomas B. Okarma, and a spokesman for the Food and Drug Administration said politics had little to do with the trial’s approval.
‘[This trial] marks the dawn of a new era in medical therapeutics,’ Okarma said. ‘This approach is one that reaches beyond pills and scalpels to achieve a new level of healing.’
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