FDA Approves Human Embryonic Stem Cell Trial
Posted on: Friday, 23 January 2009, 11:40 CST
Paraplegics who can use their arms but are unable to walk will be among the first group of patients to receive the world’s first federally approved trial using controversial human embryonic stem cells.
The US Food and Drug Administration has approved Geron Corp. to initiate a Phase I clinical trial that will administer cells derived from human embryonic cells to 10 recruited paraplegic patients within two weeks of their injury.
Doctors will use the trial to gauge the level of success and safety of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries, Geron said in a statement.
They will also be looking for indications of improvement such as the return of sensation or movement in the legs, Dr. Thomas Okarma, president and CEO of Geron, told reporters.
Okarma added that the FDA’s approval to begin clinical trials is “one of Geron's most significant accomplishments to date."
“The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord," said Okarma
"These are living cells that will divide, make more of themselves and migrate throughout the lesion after injection," he added.
Embryonic stem cells can develop into any cell in the body. Progress using human stem cells has been halted in the past due to heated debates among researchers and the public alike.
The FDA granted clearance during the same week that President Barack Obama was sworn in as the new US president, but Okarma said there was no link between the new president and the announcement. In fact, Geron said the clearance involves stem cells that were eligible for federal funding under Bush, although no federal money was used to develop the experimental treatment or to pay for the human study.
President Obama is expected to loosen restrictions on federal funding and support of human embryonic stem cell research.
"A lot of hope of the spinal cord injury community is riding on this trial," spinal cord injury researcher Dr. Wise Young of Rutgers University told AP.
Okarma told Reuters the treatment should eventually become cheap and easy to mass produce because the cells can be grown in vats. He believes the cells may be useful for other diseases such as multiple sclerosis, in which nerve cells are stripped of their insulating sheaths, and perhaps strokes.
Shares of Geron rose more than 53 percent to $8 in mid-morning trading on Nasdaq after touching $8.38.
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Image Caption: A colony of embryonic stem cells, from the H9 cell line (NIH code: WA09). Viewed at 10X with Carl Zeiss Axiovert scope. Courtesy Wikipedia
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Source: redOrbit Staff & Wire Reports
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User Comments (1)
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Posted by potsonna on 01/23/2009, 19:23 Interesting! |
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