The first
clinical trial for stem cell therapy began last Friday as a
patient with spinal cord injuries received an injection of human
embryonic stem cells.
The
trial is being ran and managed by Geron
Corp., a developer of biopharmaceuticals for the treatment of
cancer and chronic degenerative diseases. The treatment on their
first patient took place in Atlanta, Georgia at the Shepherd
Center, which is a spinal cord and brain injury center.
Stem
cells have come a long way since Hans Keirstead, a neurobiologist at
the Reeve-Irvine Research Center at UC Irvine, first turned human
embryonic stem cells into oligodendrocytes, which insulate nerve
fibers with fatty myelin. This coating protects the
damaged nerve cells enough to restore the ability for
signals to "travel up and down the spine again." From this
point, the stem cells were tested on animals, where rats with spinal
cord damage regained partial ability to walk and run in their hind
legs again. Now, researchers have moved on to the first human trial.
"All
of that work, all of that money sent to the ivory towers is
manifesting something," said Keirstead. "It's a real shot
in the arm for the field."
The
human trial, which is a so-called Phase I trial, is in its beginning
stages and the plan is to strictly test the treatment for safety
rather than effectiveness for right now. If the treatment proves to
be safe, researchers will then test it for effectiveness. Its proven
effectiveness could lead to the treatment of diabetes, spinal cord
injuries and other neurodegenerative diseases.
To
test for safety, researchers are enrolling up to 10 patients with
spinal cord injuries located between the third and 10th thoracic
vertebrae. The
stem cells are injected within 14 days after injury.
The
Shepherd Center in Atlanta will not be the only test site for the
trial, though. Northwestern University near Chicago, as well as seven
other centers, will be involved in this phase of the trial. The
expected duration time of the human trial is two years after the last
patient is registered.
"I've
got a couple of years of waking up and looking at the news every
day, hoping
and praying we're doing good for people and not bad,"
said Keirstead.
Researchers
have high hopes that the stem cells will prove to be safe, and
ultimately effective, but Keirstead noted that even if the treatment
doesn't give human patients the ability to walk or run once again, it
will allow them to be more in control of their bladder, bowel and
sexual functions. The key is to "greatly improve their quality
of life."