FDA Okays Embryonic Stem-Cell Trials on Humans

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.”

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