FDA Gives Green Light to First Embryonic Stem Cell Trials in Humans

By Peter J. Smith

WASHINGTON, D.C., August 3, 2010 (LifeSiteNews.com) – The U.S. Food and Drug Administration (FDA) is giving the green light for California researchers to test the effectiveness of human embryonic stem cells (hESCs) on human patients, according to the New York Times.

The trial will be the first in the U.S. to involve hESCs being injected into human test patients. The hESCs were developed by Geron Corporation and the University of California, Irvine. Proponents of hESC research claim that embryonic cells can turn into any cell of the body; critics, however, point out that such research involves the morally problematic destruction of living human embryos for their stem-cells.

Additionally, while embryonic stem cell research has failed to yield any practicable cures to date, adult stem-cell research has raced ahead, yielding many successful therapies and cures for illnesses, without having to cross any ethical boundaries.

Geron is attempting to develop hESCs into a therapy for individuals with very recent spinal cord injuries – within two weeks – that would repair the damaged insulation (myelin) of nerve cells and restore their ability to transmit signals.

The Times notes, however, that Geron was first cleared by the FDA to begin clinical trials in January 2009, and then stopped. The reason for the hold?: cysts were discovered in mice injected with embryonic stem-cells, prompting the FDA to put the kibosh on the trial until Geron came up with another mouse study.

David Prentice, Senior Fellow for Life Sciences at Family Research Council (FRC) noted on FRC’s blog that “many pro-embryonic stem cell scientists have expressed concerns about Geron’s trial, that it is not proven even in rats, and could cause harm to the patients.”

The Times reports that only a small number of patients will be part of Geron’s “phase 1 study” to determine the safety of the therapy, or if it even works.

Prentice also pointed out that Geron’s proposed hESC therapy is limited only to injuries sustained within two weeks of the trial, compared to the more expansive spinal injury therapies using adult stem cells that already exist.

“In terms of real effectiveness, even for patients injured years previously, adult stem cells have already shown published scientific evidence not only for safety, but for the reality of successful repair of spinal cord injury in patients,” Prentice said.

The FDA’s approval of the Geron test has drawn fire from the Vatican.

"Despite the efforts that are made to deny it, science continues to show us that the embryo is a human being in the making," Elio Sgreccia, a former head of the Pontifical Academy for life, told Vatican Radio.
 
Sgreccia said that human embryos are "sacrificed to extract the stem cells from them," and regardless of the cures being sought, such a process "from an ethical point of view can only receive a negative judgment."



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