US to carry out first human stem cell trials
US biotech firm Geron Corp. announced on Friday it had been cleared to carry out the first human trials using embryonic stem cells, testing the therapy on patients paralysed by spinal-cord injury.The Menlo Park, California firm said in a statement that the US Food and Drug Administration (FDA) had cleared it for the first phase of trials of a novel therapy called GRNOPC1.
Embryonic stem cells are highly versatile, primitive cells capable of developing into any tissue of the body.
The goal is to inject cells into the spines of paralysed volunteers in the hope that this will prompt damaged nerve cells to regrow, enabling the patients to eventually recover feeling and movement.
"The clearance enables Geron to move forward with the world's first study of a human embryonic stem cell based therapy in man," Geron said.
The company hailed the step as "the beginning of what is potentially a new chapter in medical therapeutics."
There was no immediate confirmation of Geron's announcement on the FDA website early Friday.
Stem cells are a source of huge interest in medical research.
Supporters point to the vision of material that can be grown in a lab dish and then transplanted, regenerating tissues destroyed by disease, accident or war.
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Published: January 23 2009 08:13 Last updated: January 23 2009 08:13
US regulators have approved the first use of embryonic stem cells in humans.
The move raises the prospect of a groundbreaking approach to medical treatment that had been blocked since 2001 by George W. Bush as president. Just two days after the inauguration of President Barack Obama, who opposed his predecessor’s ban on federal funding for embryonic stem-cell research, the Food & Drug Administration authorised Geron, a US biotech company, to begin clinical trials for patients with severe spinal cord injuries.
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Thomas Okarma, president and chief executive of Geron said: “This is the dawn of a new era. This goes beyond pills and scalpels to achieve a new level of healing.” He said there could be setbacks. Geron would need to recruit at least eight patients, and follow their progress for at least a year but “if we can turn a quadriplegic into someone who can walk with a cane, this will go fast-track like lightning”.
US regulators have approved the first use of embryonic stem cells in humans.
The move raises the prospect of a groundbreaking approach to medical treatment that had been blocked since 2001 by George W. Bush as president. Just two days after the inauguration of President Barack Obama, who opposed his predecessor’s ban on federal funding for embryonic stem-cell research, the Food & Drug Administration authorised Geron, a US biotech company, to begin clinical trials for patients with severe spinal cord injuries.
~snip~
Thomas Okarma, president and chief executive of Geron said: “This is the dawn of a new era. This goes beyond pills and scalpels to achieve a new level of healing.” He said there could be setbacks. Geron would need to recruit at least eight patients, and follow their progress for at least a year but “if we can turn a quadriplegic into someone who can walk with a cane, this will go fast-track like lightning”.
posted by Kangaroo Brisbane Australia at 12:15 PM
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