First Patient Treated in U.S.-Approved Embryonic Stem
MONDAY, Oct. 11 (HealthDay News) -- The first patient to be
treated in a U.S.-government-approved study involving human
embryonic stem cells has been injected with millions of the
potentially life saving cells.
The patient, being cared for at the Shepherd Center in Atlanta,
is partially paralyzed following a spinal cord injury. The center
specializes in treating these types of injuries.
According to the trial's protocol, patients must receive the
stem cell injection within 14 days of the injury. The trial only
involves patients with spinal cord injuries.
"We've known about this for a long time, we've been waiting for it to happen and we hope it goes well. Definitely it's a step forward," said Susan L. Solomon, CEO of the New York Stem Cell Foundation.
Paul Sanberg, professor of neurosurgery and director of the
University of South Florida Center for Aging and Brain Repair in
Tampa, added: "Clearly this bodes well, in the sense of getting
stem cells to the clinic, especially in spinal cord injury. This is
a safety study, and once that continues, hopefully there will be
While many scientists and physicians are hailing the trial as a
landmark, others have expressed some nervousness.
"There's a lot of angst around these trials," Evan Y. Snyder, director of the stem cell program at the Sanford-Burnham Medical Research Institute in San Diego, told the Washington Post. "There's going to be this perception that if the cells do not perform well, the entire field will be illegitimate."
Spinal cord injuries are just one of several conditions and
diseases that scientists hope can one day be treated, cured or
prevented with stem cell therapy. Others include Alzheimer's
disease, Parkinson's and diabetes.
Although researchers around the world have made strides in the
field, until now, no clinical trials have gotten under way in the
The current Phase I trial, sponsored by Geron Corp. of Menlo
Park, Calif., is mainly looking at the safety of using embryonic
stem cells in this context. If all goes well, later trials will
assess the strategy's effectiveness.
In an announcement released Monday, Geron president and CEO Dr.
Thomas B. Okarma said that "initiating [this] clinical trial is a
milestone for the field of human embryonic stem cell-based
According to the company statement, another center, Northwestern
Medicine in Chicago, is also enrolling patients for a similar
In all, seven sites will be involved in the study, the
Embryonic stem cell therapy has been a major source of
controversy and political drama for years. Early in President
George W. Bush's first term, his administration banned federal
funding for research using newly created embryonic stem cells,
citing ethical concerns that these cells represented viable human
That ban was overturned by the Obama administration, but in late
August U.S. District Court Judge Royce Lamberth ruled that federal
funding of embryonic stem cell research did violate a 1996 law
prohibiting the use of taxpayer dollars for such work. The Obama
administration appealed that decision.
Soon after, an appeals court issued a temporary suspension of
the reinstituted ban until it could hear full arguments over the
next few weeks.
In the wake of that stay, U.S. government officials announced
that researchers at the National Institutes of Health would resume
working with embryonic stem cells.
Meanwhile, results of a new Harris Interactive/HealthDay poll
released last week found that a wide range of Americans, including
Republicans, Catholics and born-again Christians, supported
embryonic stem cell research. Almost three-quarters (72 percent) of
the adults surveyed believe that scientists should be allowed to
use embryonic stem cells left over from in vitro fertilization
procedures to search for potential treatments or ways to prevent
diseases such as Parkinson's, Alzheimer's and diabetes.
Find out more about stem cell research at the
National Institutes of Health.
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