US allows use of embryonic stem cells

[Aaron]

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.

While commercial and academic researchers have begun to use adult stem cells to treat patients, Geron, based in Menlo Park, California, has moved furthest and fastest in the field of embryonic stem cells, which scientists believe have far greater potential in treatment because they can evolve into any cell in the body.

The FDA decision paves the way for Geron to start trials in patients to test the safety of its product, called GRNOPC1, after which it will need fresh regulatory approvals to show efficacy before potential commercialisation within as little as three years.

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”.

Mr Okarma said there were considerable challenges for regulators in ensuring safety in the fledgling field of embryonic stem-cell treatment. The chief executive was not aware of any political interference in the decision of the FDA, which had respected a series of deadlines since the company first sought approval in March.

But he criticised the “crazy” period following President Bush’s ban on federal funding, which he said left Geron isolated in supporting embryonic stem-cell research while many other researchers had followed financial support to study less promising uses of adult stems. “This is a triumph of private innovation over public inertia,” he said, stressing that Geron had invested $200m since 1995 in the field, and that the new administration needed to draw up more ambitious plans than simply permitting federal funding.

Mr Okarma said Geron could achieve important economies of scale designed to ensure that the price of the new treatment would be “reasonable”. The chief executive said he was keen to license its technology to other developers of stem cells to treat a variety of different treatments.

[Latinoguy]

finally!

[Diegoscp]

(01-23-2009 11:11 PM)Mauricio Wrote:  finally!

Mauricio is so excited lol

[carlyse_09]

I've heard a lot of good things about it as a cure in some illness as well as in beauty treatments.It was finally approved and hopefully it will really help.

[Latinoguy]

(02-01-2009 08:01 AM)carlyse_09 Wrote:  I've heard a lot of good things about it as a cure in some illness as well as in beauty treatments.It was finally approved and hopefully it will really help.

in a few years, we will have people who are stuck in a wheelchair walking even if its with a cane...still its a lot
Embryonic stem cells are "blank" so they can be use for anything...think of the possibilities..considering that we are made of cells

[RebelArmzMack]

Ok .. Sounds Decent i think lol i dunno much about this