NIH Stem Cell Rules Seriously Flawed, Says Stanford Expert

STANFORD, Calif.--(Business Wire)--
Today the National Institutes of Health released their final guidelines
detailing what types of human embryonic stem cell research will qualify for
federal funding. Although the rules permit federal funding of research on
embryonic stem cell lines produced from excess early embryos from in vitro
fertilization clinics, they disallow federal support of two key techniques used
to derive embryonic stem cells in animals: that of transferring the genetic
material from one cell into an egg without a nucleus, and that of stimulating an
unfertilized egg to divide.

"In terms of extending the classical embryonic stem cell lines that can be used
with federal funding, this is an important step forward," said Stanford
University School of Medicine stem cell researcher Irving Weissman, MD.
"However, the policy banning funding of other stem cell lines produced by
transferring the genetic material from a patient to an egg is a terrible
disappointment. It seems inconsistent with the president`s promise to allow
scientific facts to determine science policy." On March 9, President Barack
Obama made a statement about his administrations approach to science policy, in
which he vowed to ensure "that scientific data is never distorted or concealed
to serve a political agenda, and that we make scientific decisions based on
facts, not ideology."

The nuclear transfer process, also known as SCNT or "therapeutic cloning," has
been used to derive embryonic stem cells in many animal species. Recent
successes in non-human primates, such as monkeys, suggest that researchers will
eventually be able to duplicate the feat in humans. However, the rules bar
federal funding of research on any human cell lines derived in such a manner,
even if their derivation was consistent with all medical ethical considerations.

"They could have said that they would evaluate these stem cell lines when and if
they are derived to determine whether they met the appropriate ethical
standards," said Weissman, who directs Stanford`s Stem Cell Biology and
Regenerative Medicine Institute. "Instead, their only justification for not
funding research on these lines was that SCNT didn`t have public support."

Many who oppose human embryonic stem cell research point to recent advances in
another technique called induced pluripotency that "reprograms" adult cells to
look and act like their embryonic counterparts. Focusing on these so-called iPS
cells, they argue, circumvents any ethical qualms about the use of human
embryos. Although such research is important and has been replicated at Stanford
and elsewhere, Weissman said, iPS cells can cause cancer in mice if any of the
genes used to reprogram the cells remain active.

In contrast, SCNT has been shown in mice to generate stem cell lines that
reliably reproduce the genetics of the donor. Furthermore, when SCNT-derived
cell lines bearing disease-causing mutations are introduced into developing
mice, the recipient animals themselves develop the disease-a proof of principle
that has not yet been shown with iPS cells.

In fact, organizations like the International Society for Stem Cell Research, of
which Weissman is president, had urged the NIH to allow federal funding for
research on both iPS and on SCNT-derived human embryonic stem cell lines. "The
NIH is gambling that iPS cells will be functionally equivalent to human
embryonic stem cells," said Weissman. "But we don`t yet know if diseases like
juvenile diabetes, cancer or Lou Gehrig`s disease can be recapitulated in this
manner."

The Stanford University School of Medicine consistently ranks among the nation`s
top 10 medical schools, integrating research, medical education, patient care
and community service. For more news about the school, please visit
http://mednews.stanford.edu. The medical school is part of Stanford Medicine,
which includes Stanford Hospital & Clinics and Lucile Packard Children`s
Hospital. For information about all three, please visit
http://stanfordmedicine.org/about/news.html.

Stanford University Medical Center
Krista Conger, 650-725-5371 (Print Media)
kristac@stanford.edu
Margarita Gallardo, 650-723-7897 (Broadcast Media)
mjgallardo@stanford.edu

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