Embryonic Stem Cell Trial Gets FDA Approval

Embryonic stem cell trial gets FDA nod

Proponents of embryonic stem cell research won a major victory Jan. 23 when a biotechnology company announced it has received approval from the U.S. Food and Drug Administration for clinical trials using embryonic stem cells in human beings.

Thomas Okarma, president of the California-based Geron Corp., said his company plans to enroll up to 10 paralyzed patients who can be treated within 14 days of sustaining a spinal cord injury.

Geron will inject embryonic stem cells into the spine at the site of the damage. According to the company, if the cells behave like they have in some animal studies, the cells will mature and repair a lack of insulation around the nerves, restoring the ability of some nerve cells to carry signals.

Geron said it will monitor the patients for at least a year to determine primarily whether the procedure is safe and also whether it is effective.

Embryonic stem cell research has been a controversial issue because the extraction of cells from an embryo destroys the life of a tiny human.

Ben Mitchell, a professor of bioethics and contemporary culture at Trinity Evangelical Divinity School in suburban Chicago, had told Baptist Press prior to the Geron announcement that it involves purposefully killing living human beings in order to test medical treatments for other human beings.

"Geron and their cheerleaders may try to spin it another way, but that is precisely what's going on," Mitchell, a consultant on biomedical and life issues for the Southern Baptist Ethics & Religious Liberty Commission, said.

"And as they grasp for hope, individuals suffering from terrible illnesses are being tempted to become complicit in the destruction. If an effective therapy eventually does emerge, people with pro-life consciences will have to refuse treatment. The whole scenario is grotesque," Mitchell added.

The news is being hailed as a watershed moment by some researchers because it marks the first time the FDA has allowed embryonic stem cells to be implanted in humans. Also the approval coincides with the inauguration of Barack Obama, who had pledged to loosen the restrictions the Bush administration had placed on embryonic stem cell research, though officials say the two occurrences were not connected.

Mitchell expressed disappointment that the FDA doesn't place a higher value on human life.

"The FDA makes its decisions about drugs and procedures on the basis of safety and effectiveness," he had said. "Since they don't regard human embryos as persons, their safety does not matter. As we know from the FDA's approval of the abortion drug RU 486, the destruction of unborn human life is not of great importance to our federal drug agency."

Unlike research using embryos, extracting stem cells from non-embryonic sources -- such as umbilical cord blood, placentas, fat and bone marrow -- has nearly universal support and has produced treatments for more than 70 human ailments, according to Do No Harm, a coalition promoting ethics in research. Lupus, multiple sclerosis, heart disease, Crohn's disease and diabetes are among the ailments that have been successfully treated with non-embryonic stem cells.

Jackie Rabon, a young woman from Illinois, is an example of the strides that have been made in adult stem cell research. She was paralyzed during an automobile accident but has learned to walk again using a walker and leg braces following a surgery that placed her own adult stem cells into her spinal cord.

Rabon told Baptist Press she believes there is much hope in adult stem cell research, and she is sure that once the word gets out, more people will want to have adult stem cell therapy. She can testify that it has improved her life, and no other lives were harmed in the process.

Geron's Okarma said he doesn't expect his trial to make someone get up and dance shortly after receiving treatment, but he believes patients can be given some level of ability that can be improved by physical therapy. Several media outlets have said years of testing would follow any success Geron achieves before the treatment could become widely available to patients.

The FDA approval comes about 10 years after the first human embryonic stem cells were isolated at the University of Wisconsin, an endeavor financed by Geron.

Some researchers, such as John Kessler at Northwestern University, are skeptical about Geron's ability to achieve a successful trial. He told The New York Times that results showing the therapy worked in moderately injured animals might not apply to more seriously injured people. Also, he feared that if the therapy proves unsafe -- or even ineffective -- in people, it could cause a backlash that would set the field back for years. He was not convinced the Geron trial is the best for the first embryonic trial in humans.

Steven Goldman of the University of Rochester said the main safety concern is that if raw embryonic cells are put into the body they can form tumors, as proven in laboratory animals. Even if such tumors didn't spread like other cancers, any unwanted growth in the spinal cord can further damage nerves, The Times said.

The cells Geron has been using were eligible for federal funding under the Bush administration because they were derived from leftover embryos at fertility clinics before 2001 when Bush began restricting federally funded embryonic stem cell research, according to the Associated Press. But Geron's research to this point has been privately financed.

Contact: Erin Roach
Source: Baptist Press
Source URL: http://www.bpnews.net
Publish Date: January 23, 2009
Link to this article:
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