- The Washington Times - Thursday, December 3, 2009

Scientists received a green light Wednesday to apply for use of 13 human embryonic stem-cell lines from an approved list developed by the National Institutes of Health, the government’s prime medical research agency.

In making the announcement, Dr. Francis S. Collins, NIH director, said the decision was in accord with guidelines adopted in July and more lines, called batches, are likely to be added in the future.

The stem-cell lines, created by Children’s Hospital Boston and Rockefeller University, “were derived from embryos that were donated under ethically sound informed consent processes,” Dr. Collins said.

The decision gives scientists greater leeway in their ability to explore new treatments for diseases, conditions and disabilities and help test the safety of new drugs in the laboratory. Previously, they could do such work using embryonic stem cells under private grants and money.

President Obama in the spring lifted eight years of restrictions on such cells that had limited public tax money from being used on 21 previously approved lines. It was expected that the new administration would change the policies but it took time to review the batches now available.

Federal law forbids the use of government money for making stem cells that require the destruction of a human embryo out of which they are formed. An NIH review panel had determined that in order to meet these restrictions cell lines would come from donated embryos at fertility clinics where parents had signed consent forms.

The power of the embryo comes from its ability to grow all the cells and tissues of the human body, but not all embryos serve equally well for this. There is a great deal of variation in quality based on their genetic makeup and conditions under which they are handled. Scientists have developed ways to use ordinary adult cells as substitutes, but work done with them normally has a different purpose and does not involve investigation into basic biological processes.

Stem cells taken from adult tissue - as opposed to embryonic ones taken from the inner part of blastocysts about five days old - can have separate uses, including in bone marrow transplants done for 25 years to treat leukemia.

“It’s not a question of being weaker, but there are some organ systems from which you can’t get stem cells,” said B.D. Colen, spokesman for the Harvard Stem Cell Institute, where the first 11 lines on the expanded list were made.

Demand among researchers for access to new and better lines has been pent up through the years. More than 30 NIH proposals funded in the current fiscal year for a total $200 million were delayed until the approved lines on the NIH registry became available.

“This [decision] really changes the view of the field in the sense that stem-cell researchers - beyond the handful of lines President [George W.] Bush had approved - can apply for NIH funding competitively with anyone else doing this kind of work,” Mr. Colen said. Having more lines of stem cells gives researchers tools to both study disease and develop drugs for treatment.

Hope for the future lies in being able to possibly replace damaged heart muscle in humans, as has been done experimentally in mice. “We might be able to take cells from patients that have diseases with a genetic base to reproduce the disease in the lab and test drugs for it in the dish,” he added.

The Harvard Institute involves all areas of scientific research at that academic center, including the work done in affiliated hospitals. All previous work done at Harvard with stem cells has been funded privately and has enabled the institution to distribute stem-cell lines to about 200 other labs around the world.

New York’s Rockefeller University and Children’s Hospital Boston, affiliated with Harvard, created the first 13 on the list.

The development gives scientists the means to work with the best materials, said Don Gibbons of the California Institute of Regenerative Medicine, a state agency.

“The old lines were not very functional. The 13 approved are all newer ones done with newer technologies. A lot of scientists want to use a more robust line.”

The move should allow the United States to catch up with countries abroad, such as Britain and even Singapore, which had been funding heavily in this research, he said. “If you look at stem-cell research, we are from 10 to 20 years below other fields. Our scientific productivity is behind in this field. It has slowed getting new methods to patients. ”

The debate has shifted, said Arthur L. Caplan, director of the Center for Bioethics at the University of Pennsylvania. “Some of this debate has become not so much ‘what is an embryo’ but ‘are we going to be able to deliver on the promise’ and ‘we better do this to stay in the game.’ Even among conservatives and liberals, the dividing lines aren’t always what you expect.”

The religious community is split over stem cells with most mainline Protestant and Jewish groups approving the research and Southern Baptist, Catholic and Lutheran Church Missouri Synod denominations opposing it.

The Roman Catholics have been the most vociferous opponents of the procedure, most recently on July 7 when Philadelphia Cardinal Justin Rigali condemned the NIH’s research, saying the comments of “tens of thousands of Americans opposing the destruction of innocent human life for stem-cell research were simply ignored in this process.”

Of particular concern were what he called “specific abuses” in the draft guidelines.

“For example, federally funded researchers will be allowed to insert human embryonic stem cells into the embryos of animal species other than primates,” he wrote. “Federal grants will be available even to researchers who themselves destroyed human embryos to obtain the stem cells for their research.”

Richard Doerflinger, associate director of the United States Conference of Catholic Bishops’ Secretariat of Pro-Life Activities, said Wednesday the newest trends in stem-cell research are going toward using adult or pluripotent stem cells that do not involve destroying an embryo.

“The politics is going in one direction but the science is going in another,” he said, “and NIH is behind in terms of the science. Even people fiercely devoted to embryonic stem-cell research have been moving in the direction we’ve been recommending all along.

“We object to using taxpayer dollars for these 13 lines because it encourages scientists to destroy more embryos to obtain more new cell lines. But it is also true that the smart money is going into other avenues.”

Some of the fights about the moral status of the embryo have faded, Mr. Caplan said.

“That isn’t to say the abortion debate has gone away. When the economy turns south and the rest of the world is scrambling, it just adds a broader context to the debate. A proponent will say it’s interesting to worry about embryos, but ‘I’m worried about my brother who came back from Iraq’ and needs medical treatment of the most advanced kind.”

Julia Duin contributed to this report.

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