US Company applies to FDA to conduct human embryonic stem cell trials in humans
Jaydee Hanson
Dear Colleagues:
I thought you would want to see this report that Geron, a company that has been trying to clone human embryos, plans to start human trials using embryonic stem cells.
Jaydee Hanson International Center for Technology Assessment
Geron aims to be first in human trials with ESCs
By admin
Created Feb 12 2008 - 7:59am
In a first, Geron made headlines at the BIO CEO conference in New York with its announcement that it could begin its first human trials using embryonic stem cells to treat spinal cord injuries as early as this spring. Geron first has to meet the "high bar" set by the FDA, says Geron CEO Thomas Okarma. Geron is in a race to start the first FDA-approved ESC trials. Advanced Cell Technology [1], which has been trying--unsuccessfully so far--to find a way around the controversy generated by ESCs by creating new stem cell lines without destroying embryos, also plans to launch human trials this year. Novocell [2] is believed to be further back in the field. But no one believes that FDA approval will be quick and easy.
"This is the first time that a human embryonic stem cell application is being submitted to the FDA, so there's a good chance that some questions will arise," said Ren Benjamin, analyst for Rodman & Renshaw.
A significant crowd has turned out for the annual biotech confab. Organizers of the conference estimate attendance at around 2,500, noting an increase over last year's gathering of biotech executives.
- read the report [3] from CNN
ALSO: A number of stem cell companies say that this is going to be a watershed year in development work. Report [4]
Related Articles:
Geron: Stem cells repair heart attack damage. Report
[5]
Geron reports breakthrough in stem cell research. Report [6]
Geron faces critics' wrath. Report [7]
Source URL:
http://www.fiercebioresearcher.com/story/geron-aims-to-be-first-in-human-trials-with-escs/2008-02-12
Links:
[1]
http://www.fiercebioresearcher.com/story/act-unveils-embryonic-stem-cell-breakthrough/2006-08-24
[2]
http://www.fiercebiotech.com/story/novocell-garners-25m-stem-cell-work/2007-07-16
[3]
http://money.cnn.com/2008/02/11/news/companies/geron/?postversion=2008021115
[4] http://sanjose.bizjournals.com/sanjose/stories/2008/02/11/story1.html
[5] http://www.fiercebioresearcher.com/story/geron-stem-cells-repair-heart-attack-damage/2007-08-28
[6]
http://www.fiercebioresearcher.com/story/geron-reports-breakthrough-in-stem-cell-research/2007-05-22
[7] http://www.fiercebioresearcher.com/story/also-noted-geron-faces-critics-wrath-new-diagnostics-work-targets-prostate-cancer/2007-07-24
Jaydee Hanson
Director for Human Genetics Policy
International Center for Technology Assessment
660 Pennsylvania Ave. SE #302
Washington DC 20003
P Please consider the environment before printing this email
Wesley J. Smith
Geron has been stating their first human trial would begin within months for more than 4 years. We’ll see. WJS