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Adult Stem Cell Human Trial
Begins to Treat Spinal Cord Injury
By Wesley J. Smith
Editor's note. This appeared
yesterday on Wesley's blog at
http://www.firstthings.com/blogs/secondhandsmoke/
There have been human trials
ongoing around the world using adult stem cells from olfactory
tissues to treat paralysis caused by spinal cord injury--most
famously by Dr. Carlos Lima. In peer reviewed studies, this
treatment has been found to restore some sensation to many of
the patients enrolled. Now, an American human trial has begun
using bone marrow.
From the story [The title is
"Paralyzed Iraqi War Veteran Will Be First to Receive Adult Stem
Cells to Treat Spinal Cord Injuries at TCA Cellular Therapy "
and can be found at
www.businesswire.com/portal/site/topix/permalink/?ndmViewId=news_view&newsId=20100804006365&newsLang=en]
TCA Cellular Therapy, LLC has
enrolled its first patient to participate in the U.S. Food and
Drug Administration (FDA) first adult stem cell clinical trial
to treat spinal cord injuries. Enrollee and Marine Veteran, Matt
Cole was paralyzed from the chest down in a 2005 insurgent
attack in Iraq. "At minimum, our team expects this therapy will
provide some improvement to the patient's motory and sensory
functions with no side effects." According to the National
Spinal Cord Injury Statistical Center (February 2010), it is
estimated that up to 311,000 people in the U.S. are living with
a Spinal Cord Injury with the average health care and living
expenses cost for the first year following the injury as much as
$830,000 per patient.
TCA Cellular's neurological team
is led by stem cell experts Jose J. Minguell, PhD, Carolina
Allers, PhD, and Gabriel Lasala, MD, neurosurgeon Gustavo
Gutnisky, MD, and neurologist Srinivas Ganji, MD. The team is
scheduled to treat ten patients in Phase I. "Many spinal cord
injury patients have no effective treatment available at this
time," stated Dr. Gutnisky.
"I'm very encouraged by the
results of the pre-clinical trials and anticipate this may
become a significant therapy for these patients in the near
future." Utilizing TCA Cellular's proprietary therapy, a couple
of thousand adult stem cells have been extracted from the
patient's own bone marrow, Mesenchymal Stem Cells have been
separated, purified, multiplied to millions and will be infused
into Cole's spinal cord later this month. "In theory we expect
the cells to repair damaged neurons," explained TCA Cellular
president, Dr. Lasala. "At minimum, our team expects this
therapy will provide some improvement to the patient's motory
and sensory functions with no side effects."
Remember, this is very early
experimentation. Stage 1 is primarily intended to test safety.
We are a long way from this approach entering the clinical
setting, if it ever does.
Still, I find it funny–and not in
the ha, ha, kind of way–that these adult stem cell stories never
receive the kind of intense media attention that embryonic stem
cell experiments with rats do, not to mention the on again, off
again, and now, on again Geron human ESC trial. But they offer
tremendous hope to alleviate tremendous amounts of suffering–and
with no ethical baggage. |