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First human stem cell test begins
Doctors have started a landmark clinical trial to use embryonic human stem cells to treat a man's spinal injury.
Last Modified: 12 Oct 2010 00:35 GMT

The first human study of embryonic stem cell use will look at the safety of the treatment [Getty Images]

Doctors at a special spinal cord and brain injury clinic in the United States have begun treating the first person admitted into a landmark clinical trial to study the use of embryonic human stem cells to cure serious diseases and repair devastating injuries.

The man, whose personal information is being kept confidential, was enrolled at the Shepherd Center in Atlanta, Georgia, on Monday, according to a press release from the Geron Corporation, which won approval from the US Food and Drug Administration (FDA) in 2009 to begin the trial.

The Phase I trial, as it is called, will involve only eight patients and is not meant to see if the stem cells "cure" the volunteers, only that they do no harm.

The use of embryonic stem cells from unborn fetuses is controversial, especially in the United States, where it has prompted lawsuits against the government. Opponents, notably religious conservatives, believe it is unethical to use the genetic material of unborn children.

Enrollment period will last months

All eight patients in the Phase I trial will have suffered some kind of injury to their spinal cord, said Dr. Richard Fessler, a Northwestern University professor, who is leading the study.

The injury must fulfill certain criteria: The spine can be crushed but not severed, and the patient must not have an infection or a history of cancer. Patients will be provided with an independent advocate to ensure they are not pressured into making decisions. But potential volunteers have only two weeks - or 11 days once a period of "preoperative testing" is subtracted - to make their decision, Fessler said.

Since doctors will spend a month observing each patient after they are admitted before allowing a new volunteer into the study, the enrollment period will last at least eight months, he said. After that, Fessler said, doctors will not know for months whether patients are experiencing any kind of improvement in the use of motor skills or senses or bladder control.

Trumpeting of new study 'irresponsible'

Dr. David Prentice, a senior fellow for Life Sciences at the conservative Family Research Council, a Christian advocacy group, told ABC News that Geron Corp. is "irresponsible" for flaunting its trial and that adult stem cells - instead of those from fetuses - have proven effective at treating spinal cord injuries.

Geron Corp. received approval from the FDA to test specific nervous-system cells, called oligodendrocytes, in 2009, but the government paused the trial until this year.

Geron, a publicly traded biotechnology company that has aimed primarily to develop treatments for cancer, is the first of a number of businesses looking for FDA approval to test stem cells on humans. Geron previously tested rats and mice.

The company went public in 1996 and has yet to turn a profit, posting a net loss of roughly $70.4 million in 2009.

Source:
Al Jazeera and Agencies
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