Oct. 31, 2009
Geron now says that it hopes its embryonic stem cell experiment on spinal cord injury patients might begin in the 3rd quarter of 2010. The original FDA approval to test the cells in patients was given in January 2009 and Geron claimed it would begin in the summer of 2009, but before a single desperate patient had been injected with the potentially-dangerous cells, the FDA placed a hold on the Geron experiment due to safety concerns.
Meanwhile, the obsession with embryonic stem cells has obscured the real hope for patients--ADULT STEM CELLS. Peer-reviewed evidence of adult stem cell success for spinal cord injury patients has already been published by groups in Portugal, in Australia, in Ecuador, and in Brazil.
Of course, Geron's latest announcement achieved its primary goal--Geron stock rose as much as 12%.
The Geron Prophecies
Geron expects the data from this study to enable re-initiation of the clinical trial in the third quarter of 2010.
Geron says that it expects to begin enrolment early this summer at up to seven US medical centres.
A clinical trial that would test the use of embryonic stem cells to treat spinal cord injury could begin within three months.
But the FDA is nearing the end of its review process and may lift the hold and allow clinical trials to commence within the next three months, Okarma told The Scientist.
The Geron Corporation announced Wednesday that its plans to begin the first clinical trial using embryonic stem cells had been delayed by federal regulators. While companies typically do not announce when they submit an application to begin a trial for an investigational new drug, the F.D.A.s action means Geron must have submitted its application in the last 30 days, Mr. Benjamin said.
The first experiments using human embryonic stem cells in human subjects could begin within a few months, the chief executive of biotech Geron said Monday. At the annual BIO CEO conference in New York, Dr. Thomas Okarma said Geron plans to start embryonic stem-cell studies in humans with spinal cord injuries toward the end of the second quarter. Okarma said the tests would involve up to 40 human patients, while all prior tests involved rats.
Gerons development plan for the product calls for the filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration and, pending the agencys review, initiation of human clinical trials in 2008.
Geron, based in Menlo Park, Calif., has been using rats in its experiments of a potential treatment for spinal cord injuries. Geron has already met with the FDA and will submit its plans for human testing to the agency by the end of this year, according to Sion.
"Geron Corporation in Menlo Park, California, expects to start clinical trials of a therapy for spinal cord injury early in 2008, according to spokesperson David Schull."
"The first clinical trial of embryonic stem cells is on track to start early next year on patients with spinal cord injury. Geron, the California-based biotechnology company, will carry out the study on accident victims in six trauma centres across the US."
One company, in particular, Menlo Park, CA-based Geron, is taking the lead in developing experimental embryonic stem cell therapies and hopes to begin human trials next year.
The company will apply for approval to start US clinical trials in 2007, using glial cells derived from human embryonic stem cells to treat spinal injuries.
"I'm confident that we will be in the clinic next year with the first human ESC-derived product," said Tom Okarma, chief executive of Geron, at a conference in London last week.
Tom Okarma: We will complete our IND-enabling studies, which are now in process and still on track, and file our IND during the fourth quarter of this year, assuming the preclinical data continue to go well. That starts a 30-day review clock by the FDA, who then has 30 days to either accept our IND and allow us to proceed or, at that point, they have questions that we must answer before we can begin. We are on track for that. So, assuming they bless the IND, we would hope to be in the clinic in the first quarter of (2007).
"[R]esearchers at Geron of Menlo Park want to take the next step -- in people. They hope to get federal permission to inject those cells into damaged spinal cords. The procedure -- which Geron intends to do next year -- would be the first human tests of a treatment derived from human embryonic stem cells, the highly versatile body cells that can be coaxed into becoming almost any tissue in the body."
"Geron plans to begin clinical trials on acute spinal cord injury treatment in early 2006, according to chief executive officer Tom Okarma."
Thomas Okarma, Geron's CEO, is even less convinced that larger animals are necessary before testing Keirstead's technique in humans. During an interview at the conference, he said he believes the clinical trial could begin in mid-2006.
"Next year [Hans Keirstead] and his corporate partner, Geron, plan to try treating people who have recent spinal cord injuries, in what would almost certainly be the first human trial of any therapy derived from such cells.
According to Geron CEO Thomas Okarma, the company is aiming to file an investigational new drug application with the U.S. Food and Drug Administration (FDA) requesting permission to begin clinical trials using glial cells derived from embryonic stem cells to repair damaged spinal cords in 2005 or early 2006.
"The company believes it will be cleared to start the first stem-cell therapy in human tests next year, possibly for spinal-cord injury."
Keirstead...would ask university officials to seek the U.S. Food and Drug Administration's approval to test the human embryonic stem cells on human patients with spinal cord injuries. Initially, Keirstead said he might be ready to take this step in about a year.