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Human Embryo Cloned from
Adult Cells is First in World Says Company
Major advancement
towards patient-specific and disease-specific stem cells for
therapeutic use, Stemagen says
What are the ethics? Read statement below news report
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Human Stem
Cell |
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 The beginning of human
stem cell growth - a small human embryonic stem cell colony (highlighted
in yellow) grows on a layer of "feeder cells" that provide critical
support for its continued development. (Images enhanced through specialized microscopes and software
by Stemagen) - click photo for larger view. |
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Jan. 17, 2008 – The
possibility of developing treatments for Parkinson's, Alzheimer's and
other degenerative diseases using embryonic stem cells took a big leap
forward today. Stemagen, a privately held embryonic stem cell research
company, announced it has become the first in the world to create, and
meticulously document, a cloned human embryo using somatic cell nuclear
transfer (SCNT).
Stemagen CEO Samuel H.
Wood, M.D., Ph.D., a co-author of the publication and a donor of the
cells from which the embryos were cloned, terms this achievement "a
critical milestone in the development of patient-specific embryonic stem
cells for human therapeutic use, potentially including developing
treatments for Parkinson's, Alzheimer's and other degenerative
diseases." Stemagen's research is exhaustively detailed in a paper
published in today's issue of the highly regarded peer-reviewed
scientific journal Stem Cells.
"This is not merely a
technical improvement on previous research in this area," said Andrew
French, Ph.D., lead author on the paper, "Development of Human Cloned
Blastocysts Following Somatic Cell Nuclear Transfer (SCNT) with Adult
Fibroblasts."
"No other scientific
group has documented the cloning of an adult human cell, much less been
able to grow it to the blastocyst stage, the stage at which it is the
adult donor cell that is driving embryonic development, the stage that
yields the cells (the inner cell mass) from which embryonic stem cell
lines are made," said French, who is Stemagen's Chief Scientific
Officer.
Five blastocysts were
developed from 25 donated mature oocytes. Three were confirmed to be
clones based on DNA fingerprinting demonstrating the presence of the
skin cell donor DNA in the blastocyst, while one was further confirmed
to be a clone by an additional mitochondrial DNA (mtDNA) analysis which
revealed the presence of oocyte donor mtDNA without any oocyte donor
nuclear DNA.
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The first indication
that the cloning of an embryo has been successful is the observation of
a pronucleus (above) that contains material from the donor skin cell. Stemagen
photo |
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For technical reasons, the genetic material in the
remaining two blastocysts did not amplify to the extent required for
analysis, and so while it is likely they were clones, the evidence
required to claim that with certainty was not present. Thus, in this
study, cloned blastocysts were successfully created from approximately
10% of all mature donated oocytes, an unexpectedly high rate given past
research in this field.
The oocytes used in this
study were donated, without compensation, by egg donors and intended
parents undergoing egg donation cycles for reproductive purposes at the
Reproductive Sciences Center in La Jolla, a leading fertility center
specializing in egg donation and other advanced assisted reproductive
technologies.
"As important as stem
cell research is, all of us involved in this study realized that our
overriding responsibility was to the intended parents who entrusted us
with their dream of having a child," said Catharine Adams, Ph.D., a
co-author on the paper and the laboratory director for Reproductive
Sciences Center.
"We in the IVF laboratory felt comfortable in this
collaboration because we have consistently achieved pregnancy rates of
greater than 80% from these types of high quality egg donors. In this
study, all the intended parents were successful in achieving a
pregnancy."
Stemagen and the
Reproductive Sciences Center worked closely, over an extended period of
time, with a leading independent Institutional Review Board (IRB) to
develop procedures ensuring that all parties received comprehensive
informed consent and that procedures were in place to protect their
confidentiality in the process.
All research procedures, including the
culturing of the skin cells (fibroblasts) were performed under clinical
laboratory conditions in close cooperation with the Assisted
Reproductive Technologies (ART) Laboratory of the Reproductive Sciences
Center, directed by Catharine Adams, Ph.D.
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Good coverage in San
Diego Union that is near the company in La Jolla, CA |
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S.D. firm's work major step toward creating stem cell lines
By Terri Somers
UNION-TRIBUNE STAFF WRITER
January 17, 2008
A team at the tiny San
Diego biotechnology company Stemagen has become the first to document
its successful cloning of human embryos by fusing donated egg cells with
the DNA from skin cells of an adult man, according to an article that
will be published online today by the journal Stem Cells.
Click to read more at Union-Tribune.
As human cloning advances,
ethics debate gets louder
Informed consent, human life at issue
By Sandi Dolbee
UNION-TRIBUNE RELIGION &
ETHICS EDITOR
January 17, 2008
The possible has become
the probable. A human embryo has been cloned by using a woman's egg
cells and a man's skin cells. Biology and morality have crossed paths
again.
Click to read more at Union Tribune
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French notes, "An important
reason for the success of our SCNT procedures depended on the close
coordination between our laboratory personnel and fertility center
laboratory staff. Timing is a critical element in maximizing the
probability of success in this type of procedure."
Wood points out that
this research was exhaustively scrutinized by some of the world's most
respected scientists and underwent an exceptionally rigorous process of
verification, "This achievement was so critical to our field, we felt we
should spare no effort in the process of establishing the validity of
our work."
DNA fingerprinting is
the scientifically accepted method for determining if an embryo is a
true clone. According to French, "All samples were subjected to this
type of analysis to determine their true genetic makeup."
For that, the company
turned to Genesis Genetics, a recognized worldwide leader in the field
of reproductive embryonic analysis.
Company founder and CEO,
Mark Hughes, M.D., Ph.D., said "We were proud to collaborate with
Stemagen in this important accomplishment. As the leading provider of
genetic diagnosis of human embryos, it was important for an independent
company like Genesis Genetics to be involved in the verification of this
achievement."
Stemagen, Inc., is
dedicated to the production of patient-specific embryonic stem cells for
therapeutic use through SCNT and "uniparental" embryonic stem cells
technology.
Leadership of Stemagen, Inc.
 Samuel H. Wood, M.D.,
Ph.D.
CEO, Stemagen
Dr. Samuel Wood, one of
the country’s most highly respected fertility specialists, founded
Stemagen in an effort to help harness the power and promise of stem cell
technology. While directing a internationally renowned fertility center
located in La Jolla, California, Dr. Wood became acutely aware of the
tragedy of unused frozen embryos being discarded when couples completed
their infertility treatment and realized that these embryos could serve
as the starting point for the development of treatment for presently
incurable degenerative diseases like Parkinson’s and Alzheimer’s
Disease.
Dr. Wood's distinguished
academic background also includes a Master's degree in Psychology, a
Ph.D. in Biochemistry and Molecular Biophysics, and an M.B.A. He is
Board Certified in both Obstetrics and Gynecology and Reproductive
Endocrinology and Infertility and has served on the Clinical Faculty at
UCSD. Dr. Wood has been featured in many local newspaper, radio, and
television stories as well as several nationally broadcast stories,
including Frontline, Good Morning America, and the Discovery Channel as
well as a BBC documentary that has now been seen in over 50 countries.
 Andrew French, Ph.D.
CSO, Stemagen
With almost 20 years
experience in both academia and private industry, Andrew French, Ph.D.,
Stemagen’s Chief Scientific Officer, is one of the world’s most
accomplished experts in mammalian cloning. Over the last six years, Dr.
French has held senior research positions in the Centre for Early Human
Development at Monash Institute of Reproduction and Development, Monash
University where he was Project Leader for Reproductive Technologies and
managed the R&D activities of 10 staff and over 20 students.
Dr. French’s personal
research interests and accomplishments in the field of reproductive
biotechnology have included the production and characterization of
laboratory and domestic transgenic animals, genetic engineering for
improved growth rates and xenotransplantation. His group was the first
to generate elite transgenic and non-transgenic dairy cows using nuclear
transfer in Australia. He has published over 40 publications in
scientific journals and books and holds several patents. In 2005, Andrew
joined Stemagen to manage the development of proprietary methods for the
isolation of human embryonic stem cell lines and their use for
cell-based therapeutics.
Source: Stemagen Inc.
Web site:
http://www.stemagen.com/
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What is ethical? |
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Comment from Rev. Dr. Tadeusz Pacholczyk
Staff
ethicist and Director of Education for the National Catholic
Bioethics Center in Philadelphia - Jan
14, 2008
 A
recent strategy (so-called "embryo biopsy") for obtaining
stem cells involves "plucking off" one cell of a
multicellular embryo, with the damaged embryo sometimes
being able to survive, and continue on to the blastocyst
stage. Even though some are trying to spin the approach as
an ethical technique, it does not, in fact, resolve the
grave ethical problems raised by human embryonic stem cell
research.
Overall: While the
attempt to obtain embryonic-like stem cells for the purpose
of establishing cell lines without destroying embryos is, in
principle, morally laudable, any procedure that places at
risk the health and life of a human embryo for purposes that
do not directly benefit the embryo is morally unacceptable.
This moral standard is a postulate discernible through
reason and the natural law, and is articulated in Church
teaching as well through the teaching of Donum vitae, a key
document issued by the Holy See in 1987 that deals with
biotechnology and assisted reproductive techniques: "No
objective, even though noble in itself, such as a
foreseeable advantage to science, to other human beings or
to society, can in any way justify experimentation on living
human embryos or foetuses, whether viable or not, either
inside or outside the mother's womb" (I, 4). Furthermore,
whether for research or reproductive purposes, it is morally
objectionable and beneath human dignity to engender human
life through in vitro fertilization or other procedures
which replace the marital act and which place the embryo in
a vulnerable position and subject to the willful choices of
others even as it comes into being.
Specifically: The
"embryo biopsy" approach outlined in Lanza's paper fails to
deliver any kind of ethical solution because of at least
four serious objections:
1) A non-therapeutic
intervention is being performed on a human embryo. Perhaps
10 percent of his or her body mass is removed for research,
not for purposes of treating that specific embryo-patient
for a known medical condition. The embryo is instead
employed as a starting source for harvestable raw materials,
in a gesture that reduces young humans to commodities or
manipulable products. Human beings should never be treated
as means, but as ends in themselves, and hence
non-therapeutic research and experimentation on them as
described in Lanza's paper is ethically impermissible.
2) Embryonic humans
should not be generated in laboratory glassware. They do not
belong inside test tubes or Petri dishes. The only fitting
home for human embryos is in the warmth and shelter of their
mother's womb, not in the open lights of the laboratory
where they can be prodded, invaded and violated, as occurred
during the course of this study.
3) The technique of
preimplantation genetic diagnosis (PGD) is itself unethical,
because it poses a risk of death to the embryo, is done
chiefly to select out imperfect embryos for discarding, and
poses unknown risks of future harm when the child is allowed
to be born. In other words, it remains unclear whether
babies born after PGD testing are really as healthy as those
born without PGD testing. Few long-term follow-up studies
have been carried out on these PGD children, so it is
certainly premature at this time to argue that removing one
of the cells of an embryo has no future effects on that
individual. It took a number of years before the statistics
on in vitro fertilization were extensive enough, providing a
large enough database, to be able to discern the elevated
risk of birth defects in babies born by that technology, and
the same is likely to be true for babies born after PGD.
PGD itself is known to
reduce the rate of ongoing pregnancies and live births after
IVF. A recent study (In Vitro Fertilization with
Preimplantation Genetic Screening, Sebastiaan Mastenbroek,
et al. N Engl J Med 2007;357:9-17) confirms this.
4) The extracted single
cell may itself be totipotent, that is to say, it may be a
new human being, now able to grow into an adult on its own.
Early embryos are so flexible that occasionally when a cell
breaks off from them, an identical twin can form. Thus, one
might be destroying an identical twin of the original embryo
in order to establish the stem cell line. While this
identical twin formation can certainly occur in humans at
the two- and four-cell stage of the embryo, it may even be
possible at the eight-cell stage, though there is ongoing
debate regarding this question.
On the other hand, an
ethically acceptable alternative approach to the embryo
biopsy technique involves the recently announced technique
which transmutes skin cells into embryonic-type stem cells
by genetic manipulations. See:
●
http://www.nytimes.com/2007/11/21/science/21stem.html?_r=1&hp&oref=slogin
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http://www.ncbcenter.org
Rev. Tadeusz
Pacholczyk, Ph.D.
Fr. Tad is a
priest of the diocese of Fall River, Massachusetts. As an
undergraduate he earned degrees in philosophy, biochemistry,
molecular cell biology, and chemistry, and did laboratory
research on hormonal regulation of the immune response. He
later earned a Ph.D. in Neuroscience from Yale University,
where he focused on cloning genes for neurotransmitter
transporters which are expressed in the brain. He also
worked for several years as a molecular biologist at
Massachusetts General Hospital/Harvard Medical School. Fr.
Tad studied for 5 years in Rome where he did advanced work
in dogmatic theology and in bioethics, examining the
question of delayed ensoulment of the human embryo. He has
testified before members of the Massachusetts, Wisconsin,
Virginia and North Carolina State Legislatures during
deliberations over stem cell research and cloning. He has
given presentations and participated in roundtables on
contemporary bioethics throughout the U.S., Canada, and in
Europe. He has done numerous media commentaries, including
appearances on CNN International, ABC World News Tonight,
and National Public Radio. He is Director of Education for
The National Catholic Bioethics Center in Philadelphia and
directs the Center’s National Catholic Certification Program
in Health Care Ethics. |
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