FDA Okays Embryonic Stem-Cell Trials on Humans
But Lawsuit Would Stop Expanded Funding
MENLO PARK, Calif. — Even as a federal agency gave a California biotech firm the go-ahead to begin the first human trials of therapy employing human embryonic stem cells, a federal court approved a pro-life legal action that could lead to blocking President Obama’s promised expansion of federal funding for research using these cells.
Geron Corp. of Menlo Park, Calif., is seeking people paralyzed by spinal injuries to be the first human test subjects for the clinical use of human embryonic stem cells, which some scientists say is dangerous, wasteful of taxpayers’ dollars and unethical.
Stem cells are undifferentiated, primitive cells that have the ability both to multiply and to differentiate into specific blood cells and other cell/tissue types. This ability allows them replace dead or defective cells and/or tissues.
Embryonic stem-cell research, which involves the killing of a unique human being in an attempt to cure different diseases, has proven not only lethal and costly, but has not produced a single cure. On the other hand, adult stem-cell research, which utilizes cells from adult tissues or umbilical cords, does not require the taking of human life. It has proven successful in treating more than 70 kinds of cancers and autoimmune diseases such as multiple sclerosis.
Pope John Paul II said that all research using stem cells from human embryos was “morally unacceptable.”
In his 1995 encyclical Evangelium Vitae, John Paul said, “This moral condemnation also regards procedures that exploit living human embryos and fetuses — sometimes ‘produced’ for this purpose by in vitro fertilization — either to be used as ‘biological material’ or as providers or organs or tissue for transplants in the treatment of certain diseases.
“The killing of innocent human creatures, even if carried out to help others, constitutes an absolutely unacceptable act.”
At the end of July the U.S. Food and Drug Administration gave Geron permission to proceed with clinical trials for GRNOPC1, its privately-developed line of oligodendrocyte progenitor cells derived from stem cells from aborted unborn babies. A variant developed from animal embryos proved effective in regenerating damaged animal spinal cords, Geron claims in a press release, while a problem with cysts developing near the injection site in the test animals has apparently been addressed with “new markers and assays.”
Geron did not return the Register’s calls to explain just how these “markers and assays” reassured the FDA enough to get it to approve human trials. In its press release Geron stated the stem cells tested on animals had “demonstrated remyelinating and nerve growth properties.”
Remyelinating is the re-growth of the lining around nerves which is known to improve the transmission of signals to and from the brain and lead to the “restoration of function in animal models.”
However, Theresa Deisher, a Seattle adult stem-cell researcher who is seeking an injunction against any expansion of federal funding for embryonic stem-cell research, warns that embryonic stem-cell therapy has proved very problematic in animals.
“I will predict that in these early human trials we will probably see a short-term benefit, but it will be followed by devastation and disaster,” Deisher told the Register. “And I would ask why we as a society would go forward with that and put our taxpayers’ dollars in this area when we have adult stem cells that need taxpayer funding and that taxpayers could afford and that we know are successful.”
Deisher notes that “in animal models, in the short term, the functional benefits from embryonic stem-cell treatments are very dramatic and exciting. And then those animals form tumors, or they reject the cells and the benefit is lost.”
There are two potential causes: Either the embryonic cell lines are contaminated with residual tissue or DNA from the original donor embryo, which triggers an immune response in the recipient, or the tissue injected into the recipient grows too rapidly, creating tumors.
“Embryonic stem cells grow like weeds,” says Deisher. “They behave in many ways like cancer.” In fact, rapid growth is one of their most attractive properties, since the therapeutic purpose for such cells is the replacement of damaged tissue. Rapid growth also means that plenty of tissue can be quickly manufactured for experimental use.
The key attribute of embryonic stem cells, however, is that that they are pluripotent —they have potential to reproduce as any kind of human tissue.
Adult stem cells present a reverse image of the embryonic stem cells’ pros and cons. They are difficult to reproduce in the lab, while in the body, both when naturally occurring and when introduced in modified form for therapy, they perform amazing feats of regeneration.
Deisher says adult stem cells trigger none of the immune responses that embryonic stem cells do because they are grown from tissue taken from the intended recipient.
Adult stem cells have been used for decades to treat leukemia and other blood diseases, while more recent successful treatments have seen the repair of eyes and the replacement of windpipes.
Funding Is the Goal
Why, then, is embryonic stem-cell research so appealing?
Money, says Jean Peduzzi-Nelson of the Department of Physiological Optics at the University of Alabama at Birmingham.
She told Congress that “cloned stem cells derived from embryos with genetic defects represent the possibility of millions in patentable stem-cell lines. Adult stem-cell therapies are much better for people with diseases or injuries but generate an inferior business plan.”
However, proponents of embryonic stem-cell research cite other reasons for their preference. The Coalition for the Advancement of Medical Research, for example, claims that while embryonic stem cells have the potential to re-grow any tissue, adult stem cells can only regenerate specific kinds of tissue and they have been most useful in treating blood diseases.
What’s more, the Coalition for the Advancement of Medical Research website carries an ABC News report from July on a study undermining the potential of another alternative to embryonic stem cells. The Boston study indicates that adult skin cells that are reprogrammed into behaving like stem cells — so-called induced pluripotent cells — are not “blank slates” as previously hoped, but retain some of the characteristics of the original cell.
While ABC headlined the story “Reprogrammed Adult Cells Not an Alternative to Embryonic Stem Cells,” nobody quoted in the story drew any such conclusion.
Nevertheless, Deisher insists that embryonic stem-cell research should stick to private funding and leave National Institutes of Health money for adult stem-cell research, which cannot attract private money. “We have to rely on government funding.”
That is partly why Deisher joined fellow researcher James Sherley and a group of Christian and pro-life groups in seeking an injunction to stop the NIH from funding research using new embryonic cell lines — research authorized by President Obama last year.
Deisher and Sherley contend that such funding violates the pro-life Dickey-Wicker Amendment that Congress attaches each year to NIH’s appropriations bill. It prohibits any research grants that would cause abortions.
The plaintiffs argue that any funding of new embryonic cell lines would encourage the development of new lines, which can only be generated through more abortions. (The NIH has already decreed that research using 13 additional lines of human embryonic stem cells is eligible for funding.)
The federal government — the defendant in the case — will argue that the funding comes after the abortions, which would have happened anyway.
But so far, the only argument has been over a technicality, though a crucial one: Should the case be heard by the district court of the District of Columbia? The government said it shouldn’t because none of the plaintiffs had “standing,” that is, none was materially damaged by the funding in question.
But on June 25, the U.S. Court of Appeals for the District of Columbia Circuit ruled that Deisher and Sherley had standing because funds that would otherwise go to adult stem-cell research would now go to embryonic stem-cell research.
By mid-August the case was expected to be back in district court for argument on the merits, said Sam Casey of Advocates International, a Washington D.C.-based pro-life legal organization and part of the Deisher-Sherley legal team.
Steve Weatherbe writes from Victoria, British Columbia.