FDA delays embryonic stem cell trial
The U.S. Food and Drug Administration's postponement of a human trial
using embryonic stem cells resulted from the development of cysts in
animals undergoing tests.
The Geron Corp. acknowledged the reason for the delay in an Aug. 27
news release, saying cysts had developed at the injury sites in lab
animals. The Menlo Park, Calif., biotechnology firm announced Aug. 18
the Food and Drug Administration had placed a hold on the proposed
trial on human beings with spinal cord injuries but did not provide
details regarding the reason for the postponement.
Geron received the FDA's permission in January to proceed with the
first U.S. embryonic stem cell experiments in human beings. At the
time, the company announced its plan to inject embryonic stem cells at
the point of damage in as many as 10 paralyzed patients. The injections
would occur within 14 days of the patients' spinal cords being injured.
Pro-life advocates and others oppose embryonic stem cell research
(ESCR) based on what it does to donor embryos and potentially to
patients. ESCR's drawbacks include:
-- Extracting stem cells from an embryo destroys the tiny human being.
-- ESCR, unlike trials with adult stem cells, has yet to produce any
therapies in human beings.
-- It has been plagued by the development of tumors in lab animals.
Southern Baptist bioethicist C. Ben Mitchell said the FDA hold on
Geron's trial "shows once again that not only is it unethical to
destroy embryos for their stem cells" but ESCR "results in serious
worries about safety."
"To conduct human trials would be morally unconscionable," said
Mitchell, Graves professor of moral philosophy at Union University in
Jackson, Tenn., and a consultant to the Ethics & Religious Liberty
Commission.
In its Aug. 27 announcement, Geron said earlier experiments with
animals showed a "very low frequency of injected animals developed
microscopic cysts" at the injury site. The cysts did not proliferate,
were limited to the injury site and did not affect the animals
negatively, according to Geron. Also, no teratomas, which are tumors
that may or may not be malignant, developed in the animals.
Geron reported, however, a "just completed animal study showed a higher
frequency of cysts." Another recently finished animal trial did not
produce any cysts, according to Geron.
The firm is cooperating with the FDA in an effort to begin the human
trial, Geron said.
Because of their ability to develop into other cells and tissues, stem
cells provide hope for producing cures for a variety of diseases. The
biotech industry has long promoted research with embryonic stem cells
because of their pluripotency, which means they can transform into any
cell or tissue. ESCR has not proven nearly as effective as experiments
with other types of stem cells, however.
Trials using adult stem cells have produced therapies for at least 73
ailments in human beings, despite the fact such cells are not
considered pluripotent, according to Do No Harm, a coalition promoting
ethics in research. Among the afflictions treated by adult stem cells
are cancer, juvenile diabetes, multiple sclerosis, heart damage,
Parkinson's, sickle cell anemia and spinal cord injuries, according to
Do No Harm.
Scientists have discovered induced pluripotent stem (iPS) cells in the
last two years, producing great promise for cures without the ethical
problems of ESCR. In iPS research, scientists convert adult cells into
cells that have nearly the identical properties of embryonic ones.
Neither procuring stem cells from non-embryonic sources nor
transforming adult stem cells into embryonic-like ones harms the donor.
Since the FDA gave Geron the go-ahead to conduct a human trial with
embryonic stem cells, President Obama has overturned a ban on federal
grants for stem cell research that results in the destruction of an
embryo. President Bush issued the ban in 2001, but he permitted funds
for experiments with stem cell lines, or colonies, already in existence
at the time of his order.
At the time the FDA approved a human trial with embryonic stem cells,
the lines used by Geron were eligible for federal money, according to
the Associated Press.
Guidelines issued by the National Institutes of Health in July limit
federal funds to research involving embryos produced by in vitro
fertilization for reproductive purposes and donated by couples who no
longer want them. The couples must provide voluntary, written
permission.
A suit filed Aug. 19 in federal court contends the guidelines violate a
13-year-old congressional ban on funds for research that destroys
embryos. The plaintiffs say the guidelines violate the 1996
Dickey-Wicker Amendment, a rider to the spending bill for the
Department of Health and Human Services. The amendment prohibits
federal funds for "(1) the creation of a human embryo or embryos for
research purposes; or (2) research in which a human embryo or embryos
are destroyed, discarded, or knowingly subjected to risk of injury or
death greater than that allowed for research on fetuses in utero...."
Contact:
Tom Strode
Source:
BP
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Date: September 1, 2009
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