Friday, January 23, 2009
FDA Clears First Embryonic-Stem-Cell Therapy Trials
Geron will begin clinical trials of its therapy for spinal-cord injury this summer.
By Emily Singer
| Repair work: This animation shows glial progenitor cells, made from human embryonic stem cells, repairing nerve damage.
Credit: University of California, Irvine
|
Geron, a California-based
cell-therapy company that has been working with embryonic stem cells for the
last decade,
finally received clearance from the U.S. Food and Drug Administration to begin
clinical trials of its cell-based therapy for spinal-cord injury.
The trial is
limited to eight patients with newly acquired spinal-cord injuries who will
receive injections of the cell therapy, called GRNOPC1, within two weeks of
their accident. GRNOPC1 is made by
transforming embryonic stem cells into oligodendrocytes--a type of brain cell
that wraps itself around neurons, forming a fatty insulation layer that allows
electrical messages to be conducted throughout the nervous system. In many spinal-cord injuries, these cells are damaged, but the underlying nerve cells remain
intact. These cells are then injected into the site of the injury, coating exposed
nerves and restoring communication to the nervous system.
Scientists
published the results of a successful study testing the therapy in animals in
2005, showing that paralyzed rats injected with the cells were able to walk
again. Since then, Geron has been conducting numerous studies intended to
show the safety of the cell-based therapy, as well as developing production
methods that would make the cells as easy to use as more traditional
treatments. Geron researchers have also developed a way to reliably freeze and
thaw brain cells, so that they can be manufactured in a central location,
and then shipped to the hospitals where they will be used.
Because
embryonic-stem-cell-based therapies are so new, the FDA has had trouble deciding
how to evaluate new drug applications. (Geron's president and CEO, Thomas
Okarma, thought approval was imminent
when I spoke with him in 2006. See "Human Tests of
Embryonic Stem Cell Treatments Planned.") The initial trial is designed to
assess safety, but doctors will also measure its effectiveness, such as
improved neuromuscular control or sensation in the trunk or lower extremities.
The announcement
comes amid general excitement in the stem-cell field, thanks to Barack Obama's
promise to lift funding restrictions for embryonic-stem-cell research. (See "Braving Medicine's
Frontier.")
Geron's Thomas
Okarma said in a statement, "This
marks the beginning of what is potentially a new chapter in medical therapeutics--one that reaches beyond pills to a new level of healing: the restoration of
organ and tissue function achieved by the injection of healthy replacement
cells. 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."
This video illustrates how Geron's cell therapy works in rats.
Massachusetts Institute of Technology
Comments
camdaddy09
01/23/2009
Posts:37
yalegrad97
01/23/2009
Posts:1
My life is no more or less valuable than the unborn embryo.
While President Bush did not ban embryonic stem cell research his ban on the use of federal funds for such work was the right decision. This led to successful treatments from adult stem cells as well as new ways to aquire them. In fact the data shows there is no scientific reason to produce and harvest human tissue as if the only value of these lives was utilitarian.
kaphar
01/27/2009
Posts:2
ssptng01
11/08/2009
Posts:1
Thank goodness, it is not up to you to decide what is right for everyone. My father was in a chair for 28 years and he would have given anything to get on and off a toilet like everyone else.
I have no doubts that if your reverence for single celled life were put under close scrutiny, you would also be found to be hypocritical. I wonder if you’ve considered all the complexities surrounding the issues on your own? Or have you been guided by any “organizations” in your thinking.
I respect your right to reject these and other technologies but I don’t respect you making the decision for all people with spinal cord injuries. Many people in difficult situations, such as oppressed women in other countries, "would rather stay in their burka" than be free to do as they like. Fine, let them stay under there, but don’t force all women to wear one.
It's all a matter of conditioning, (some call it brain washing) and forgive me for saying so but as my post stinks of atheism, your post has the slight scent of religious fanaticism.
I could be wrong.
I’ll get off my soap box now, lol.
johnberlitz
01/30/2009
Posts:1
m00nface86
10/12/2009
Posts:1