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A research specialist expands human
embryonic stem cells under a microscope.

FDA Approves World's First Embryonic Human Stem Cell Trial

January 25, 2009 12:53 PM
by findingDulcinea Staff
The U.S. Food and Drug Administration has permitted Geron Corp.'s proposal to conduct a clinical trial using stem cells to treat patients with spinal cord injuries.

Experimental Treatment Hailed as Beginning "New Era" in Medicine


The company will investigate whether stem cells, which are still controversial as a medical treatment, can be used safely to repair nerve tissue in patients with crushed spinal cords.

"For us, it marks the dawn of a new era in medical therapeutics. This approach is one that reaches beyond pills and scalpels to achieve a new level of healing," Geron Chief Executive Dr. Thomas Okarma said, according to Reuters.

About 10 recently injured individuals will participate in a small, phase 1 trial during which they will be injected with stem cells to test the safety of a stem cell therapy designed to encourage the growth of nerve cells, Nature reported. 

The treatment may in the future be applied to diseases such as multiple sclerosis, strokes, Alzheimer's and Parkinson's. The FDA's decision was made the day after President Barack Obama was sworn in, though company officials said the timing was coincidental. It was announced on Friday, the Los Angeles Times reported.

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Background: Recent stem cell research

Using stem cells is controversial because embryonic stem cells are taken from human fetuses. 

Earlier this month, Glasgow researchers were planning a “major trial” to test the effects of stem cells on stroke patients, according to the BBC. The United Kingdom approved the trial after the US Food and Drug Administration rejected the proposal from ReNeuron, the company that developed the therapy, two years ago.

According to Medical News Today, “About 30% of current patients who had a stroke recover completely. However, the rest either die or become disabled for life. The only therapy that can help those permanently disabled is physiotherapy (physical therapy).”

The scientists will inject cells made from a human fetus into the brains of their patients, hoping that the “cells will regenerate areas damaged by stroke, and increase patients' movements and mental abilities,” the BBC writes. The trial is scheduled to begin next year and will, at first, follow four groups of three patients over two years.

Anti-abortion groups have opposed the trial, and the Society for the Unborn Child even called the proposal “sick.” A spokesperson for the organization claimed that, “It involves cannibalising an unborn child,” according to the BBC. 

Recently, medical experts announced that a two-year trial will begin this month on the effect of stem cells on corneal blindness, according to Agence France-Presse. The experiment, which will take place at Princess Alexandra Eye Pavilion in Edinburgh and the Gartnavel General Hospital in Glasgow, is not as controversial as the stroke trial because it involves stem cells from dead adult donors instead of embryonic stem cells.

Several recent medical breakthroughs have involved adult stem cells. In November 2008, Bloomberg reported that five months after doctors in Spain gave Claudia Castillo, 30, a new trachea with the use of stem cells, her lungs were working normally for a person her age.

Another experimental procedure uses a person's own stem cells to fix meniscal cartilage tears in the knee. In 2007, another research team said it was able to reprogram human skin cells to act like embryonic stem cells, or cells that can turn into any type of human tissue.

Opinion & Analysis: ‘Shackled’ research vs. the end of embryonic stem cells

Thomas Robey, a medical student at the University of Washington, recently reflected on the seven years since President George W. Bush enacted a ban on using federal money to develop and research new embryonic stem cell lines.

“The end result of the policy is that, anything goes if you have your own money. This slowed down all of the richest universities, but did not stop them, because research was still permitted on the ‘presidentially approved’ lines,” Robey wrote.

Though the development of another series of stem cells that look like embryonic stem cells does not make human embryo stem cell research unnecessary, they do have their benefits.

“These cells do present a true middle ground between the scientific proponents and religious opponents to [human embryonic stem cell] research,” he wrote on the blog Clashing Culture.

But Yuval Levin, a fellow at the Ethics and Public Policy Center in Washington, D.C., believes advances in other types of stem cells may be the answer to the embryonic stem cell ethics debate.

“I think that, in time, this probably will be the final chapter of this particular debate about embryonic stem cells, but I don’t think we’re at the end of it quite yet,” Levin said in a July interview with The Pew Forum on Religion & Public Life.

Reference: Stem cells explained


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