31/03/2011

Stem Cell Research

and
Public Policy

Kate Brilakis
George Mason University

Stem cell research offers hope to

countless individuals
suffering from degenerative diseases.

www.uh.edu/engines/epi2108.htm

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Stem cell research can

also assist us in better
understanding gene regulation,
thereby advancing
cancer research as well as
research in other fields
such as immunology and
developmental biology.

What

ARE stem cells??

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In the 1960's two Canadian scientists,

Ernest McCullough and JamesTill,
discovered that all living tissue
stemmed
from a single cell,
hence the term
stem cell.
Stem Cells and The Future Of Regenerative Medicine (Paperback) Institute of Medicine
(Corporate Author) (Washington, DC: National Academies Press, 2002).

Stem cells are unspecialized cells

that are able to replicate repeatedly through
cell division.
Under certain conditions, stem cells
differentiate into cells with specialized
functions.

www.reeve.uci.edu/anatomy/stemcells.php

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As cells differentiate, only a part of the genetic

information contained within the nucleus are expressed
within each cell type.
Even though all cells contain the DNA sequence
coding for a particular protein, only cells found in particular
tissues exposed to particular regulatory mechanisms
will activate the sequence to manufacture the protein.

International Society for Stem Cell Research

http://www.isscr.org/science/faq.htm

Because of this universal code, stem cells contain the

instructions and the capacity to differentiate into
any type of cell when the correct chemical regulators
are present.
Figure 1. Proteomic analysis of osteogenic
mesenchymal stem cell differentiation.
(a) Proteins from stem cells grown in
media containing differentially labeled
arginine (normal molecular, and 6 and
10 daltons heavier, respectively) and
treated with different growth factors,
are fractionated, mixed, immunoprecipitated
with anti-P-Tyr antibodies and analyzed
by liquid chromatographytandem mass
spectroscopy. (b) The results suggest
that EGF and PDGF lead to differential
outcomes in cell differentiation due to
preferential internalization of EGFR, but
not PDGFR, leading to decoupling of PI3K
signaling from EGFR, but not PDGFR.
Other pathways, such as MAPK are not affected
by endocytic down-regulation.
Differential receptor internalization is
mediated by different ubiquitination and
endocytosis pathways (green).
Nature Biotechnology 23, 828 - 830 (2005)

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Are there different types of

stem cells?
Yes

Totipotent stem cells are able to make

ALL
of the cells in the body
Pluripotent stem cells are able to make
all of these cells as well
EXCEPT
those cells which form the placenta.
Multipotent stem cells area able
to make a range of cells
WITHIN
a particular tissue type, such as blood.

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Where
are stem cells
found?

Stem cells can be found

in some of our tissues.
Somatic Stem Cells,
sometimes called
Adult Stem Cells,
are undifferentiated cells
that are found
in certain tissues.
Somatic stem cells are normally used by your body
to replace a tissues old or damaged cells.
news.bbc.co.uk/1/hi/health/6721685.stm

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Somatic tissues reported to contain stem cells

currently include
the brain,
peripheral blood,
blood vessels,
skeletal muscle,
skin
and liver.

National Institutes of Health. (2002).

Stem Cell Information. Retrieved 01-03-2008
from http://stemcells.nih.gov/info/scireport/

http://www.skally.net/ppsc/fig3.gif

The most widely recognized

Somatic Stem Cells
however, are found in bone marrow.
Bone marrow contains
Hematopoietic Stem Cells
Genetic Science Learning Center
learn.genetics.utah.edu/

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Bone marrow transplants

(HLA specific, Hematopoietic Stem Cell Transfer)
were first used in the 1960s
to treat leukemia and other blood related disorders.
The Childrens Hospital Aurora, CO

Following radiation and chemotherapy, cancer patients

often have a poor immune function,
leaving them vulnerable to opportunistic infections.

stemcells.nih.gov/info/scireport/chapter4.asp

Transplanted HSCs set up shop in the

bone marrow cavity
of the recipient, permitting a repopulation of cells
necessary for a functional immune response.

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Another stem cell product using bone marrow

cells is undergoing a 150-patient clinical trial.
Bone marrow stem cells are injected
into the heart via catheter in
hopes of regenerating damaged areas
that trigger heart failure.
The trial could be completed
by early 2009.

Japson, B. The Chicago Tribune March, 2008

http://www.chicagotribune.com/business/chi-sun-stemcell
Pittsburg Tissue Engineering Institute
http://www.ptei.org/interior.php?pageID=85

Somatic Stem Cells are/were thought to only be able

to differentiate into the different cell types
of their tissue of origin =
multipotent not pluripotent.
Some evidence suggests,however,
that Somatic Stem Cell plasticity may exist.

www.uh.edu/engines/epi2108.htm

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Plasticity or transdifferentiation is the

ability of stem cells from one somatic tissue
to generate the differentiated cell types
of another tissue.

Then, in 2006/2007, researchers successfully

reprogrammed mouse cells by adding four key genes
to those cells. The genes were responsible for
sending the somatic mouse
cells back to a pluripotent-like state.
They called the altered cells
induced pluripotent stem cells or iPSC

Kazutoshi Takahashi and Shinya Yamanaka

Induction of Pluripotent Stem Cells from Mouse
Embryonic and Adult Fibroblast Cultures by
Defined Factors
Cell 2006 126: 663-676.

www.westchesterinstitute.net

10

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The combination
of four transcription factor genes, which coded for
regulatory proteins that bind
to specific sites on the DNA, reprogrammed the
skin cells to regulate
expression of downstream genes and either activate or
silence their expression.

Kazutoshi Takahashi and Shinya Yamanaka

Induction of Pluripotent Stem Cells from Mouse
Embryonic and Adult Fibroblast Cultures by
Defined Factors
Cell 2006 126: 663-676.

Heres an example of how a

transcription factor
can regulate gene expression

employees.csbsju.edu/.../olbindtransciption.html

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Shortly after the mouse iPS cells were developed,

iPS cells were created from
human fibroblasts.
James Thomson and his University of Wisconsin Colleagues
along with
Shinya Yamanaka and his colleagues at Kyoto University
used the same basic technique
that had been used with the mouse models,

Four genes, using a retroviral delivery system,

were inserted at random locations
in the fibroblast's genome.

University of California - Los Angeles (2008, February 12).

Human Skin Cells Reprogrammed Into
Embryonic Stem Cells. ScienceDaily.

But, as in the mouse model,

the human iPS cells all contained
gene-altered viruses, and were
susceptible to cancer,
suggesting that cells produced via this method
were too dangerous to use in
any human therapy.
Coalition for the Advancement of Medical Research
http www.stemcellfunding.org/
University of California - Los Angeles (2008, February 12).
Human Skin Cells Reprogrammed Into Embryonic Stem Cells. ScienceDaily.

12

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The researchers confirmed that a new delivery system

would have to be developed before any iPS cells
could be used for clinical applications.

en.wikipedia.org/wiki/Induced_pluripotent_ste...

There are also still substantial problems to be

overcome with using traditional, somatic stem cells.
They are relatively rare.
They are hard to find.
They are difficult to culture in vitro.

The Case for Adult Stem Cell Research

by Wolfgang Lillge, M.D.
(Full text of article from Winter 2001-2002 21st Century)
http://www.21stcenturysciencetech.com/articles/winter01/stem_cell.html

13

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Nevertheless, somatic stem cell research is an exciting and

critical component in the fight against degenerative
disease.

Somatic stem cells are the body's

own mechanism for self repair. Discovering how they
function and applying this information to clinical
studies holds much promise for the future.

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Where else can we find stem cells

besides in somatic tissue?

Stem cells are

also found in blastocysts.
Just 10 years ago, researchers
discovered that some cells were able
to differentiate into
almost* any form of specialized cell.

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Blastocycts contain a type of stem cell called

an Embryonic Stem Cell
The formation of a blastocycts
can occur

in vivo
OR

in vitro.

National Institute for Health

http://stemcells.nih.gov/info/basics/basics4.asp

How do blastocysts form?

Day 1:
Fertilization occurs.
As the sperm and egg join, a zygote forms.
This process takes about 24 hours.

New York Times December18, 2001

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Day 2:
The zygote starts to divide.
Each new cell produced has the same
genetic information
as the zygote.
New York Times December18, 2001

Day 4:
The newly formed
cells gather in a ball
which
exhibits an outer
ring of cells and
an inner cell mass.
The inner cell mass is
made of
embryonic stem cells.
The entire ball of cells
is called an early
blastocyst.
New York Times December18, 2001

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The cells of the inner cell mass can be

extracted at this stage.

The cells that are extracted are

pluripotent embryonic stem cells

These cells are then encouraged to replicate in

the laboratory, forming a stem cell line.
Individual cells can then be encouraged to
differentiate
into specific types of tissues.
cmbi.bjmu.edu.cn/.../specific/specific01.htm

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Where do the blastocycts that provide

the embryonic stem cells used in research
come from?

Artificial Reproductive Technology (ART)

uses blastocycts created in vitro during
In Vitro Fertilization (IVF)

https://novaivf.com/images/IVF-2.jpg

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During IVF, blastocysts are

artificially implanted into
a uterus.
If this occurs,
the blastocyct
MAY give rise to a gastrula
following a week long
implantation process.

New York Times December18, 2001

A gastrula looks like this...

differentiation
begins as the cells are selectively
programmed to become a
particular type of tissue.

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Not every blastocyct created for an IVF cycle

is implanted AND not every implanted blastocyt
results in the development of a fetus.

Success rates for IVF (in-vitro fertilization)

The Jones Institute for Reproductive Medicine

http://www.jonesinstitute.org/ivf-success-rates.html

In 2005, of those clinics which reported their data

to the National Center for Disease Control (CDC),
134,260 ART cycles
resulted in 38,910 live births.
This means that 95,350 were unsuccessful,
Eliminating on average 3 embryos per cycle which
adds up to 286,050 discarded embryos

In the U.S., there are no federal regulations which

limit the number of embryos that can be created
or destroyed
by fertility clinics.
Center for Disease Control and Prevention
http://www.cdc.gov/art/

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In addition, many blastocycts are

cryopreserved.

Not all survive the process.

Cryopreserved/Thawed Transferred
Embryos 2000 - 2006
Optimal Embryo Survival Rate68%
Most sources quote this at <50%
( 2,390 / 3,500 )
Transfer Rate
95%
Pregnancy/Transfer
41%
( 252/619 )

The Jones Institute for Reproductive Medicine

http://www.jonesinstitute.org/ivf-success-rates.html

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Fertility clinics
routinely throw out thousands
of blastocysts each year into the trash
as medical waste.

Why havent scientists been saving and

utilizing the stem cells of these
blastocysts
for research?

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Federal funding restrictions used to

prevent researchers
from utilizing the stem cells from these blastocysts
which would otherwise
be discarded.

In 2001, the Bush administration eliminated

federal funding for
embryonic stem cell research using fresh
stem cell lines
because the president felt funding

would sanction or encourage further destruction of

human embryos that have

at least
the potential for life.
For Immediate Release
Office of the Press Secretary
The White House August 9, 2001

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Stem cell lines

created prior to 2002
were not
subject to this
funding restriction.

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This position is an attempt to allay the fears

of those who see embryo research as commodifying
the human embryo while appeasing those
who wish to pursue the therapeutic potential
ES cells offer.

D.G. Jones and C.R. Towns

Navigating the Quagmire:
The Regulation of Human Embryonic Stem Cell Research
Human Reproduction 2006 21(5):1113-1116

The ESC lines

(not 60 as cited by the administration but 22)
created prior to 2002
that are/were available
to federally funded researchers
1.

are controlled by the National Stem Cell Bank (NSCB).

Researchers must PAY handsomely for them, they divide poorly,
and are riddled with genetic abnormalities.
Larry Goldstein, a scientist at the University of California-San Diego

2.

were originally produced using a mouse cell substrate

making them useless for clinical trials.

3.

have been steadily degrading and most are useless.

4.

lack ethnic diversity. Genetic diversity is critical to the

development of treatments that will function for all humans.

Ceci Connolly & rick Weiss, "Stem cell colonies' viability unproven: Some in NIH list of 64
[lines] termed young, fragile," Washington Post, at: http://www.washingtonpost.com/

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Why does federal funding matter?

Federal funds are by far the largest single source of

research support in the world
Jonathan D. Moreno, Ph.D., is the Professor of Medical Ethics
at the University of Pennsylvania

The case for public funding is made even stronger

by the amount of embryonic stem-cell research taking
place in the private sector without public oversight.
Public funding, the reports states, would help to ensure
that the research is closely monitored
and meets ethical standards.
Scientists from The American Association for the Advancement of Science
(AAAS)
in a letter to President George W. Bush expressing its
strong support for federal funding of research using
human stem cells from embryonic, fetal and adult sources.
"It would be tragic to squander this opportunity to pursue
work that can potentially help millions of Americans in need."

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Why should we conduct research

using embryonic stem cells if there is
a chance that somatic stem cells may
be able to help cure disease?

This research is not an EITHER OR issue.

The comparison of human embryonic stem cells

to adult stem cells is currently a very active area
in research, and one that will hopefully lead to cures
for tissue degenerative diseases in the future.
International Society for Stem Cell Research
http://www.isscr.org/science/faq.htm#9

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Despite recent research into iPSCs, there

is no reason to abandon
human embryonic stem cell research.
Imagine that there are
four doors in front of you - and behind each
one is a therapy
It would be incredibly risky to say you cannot
use human embryonic stem cells...
the potential benefits
are too important and costly to close
those doors now. Landis

Story Landis, Director of the National Institute of Neurological Disorders

and Stroke at the National Institutes of Health. Washington, D.C.

Harvard University
researcher George Daley adds
"There will never be a time when we do not
need human embryonic stem cells. There may
be - one day - a particular method that does
not need embryos. But it will never obviate
the value for human embryonic
stem cell research.

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NIH supports somatic AND embryonic of stem cell

research by stating that:

Large numbers of embryonic stem cells

can be relatively easily grown in culture,
while adult stem cells are rare
in mature tissues and methods for expanding their
numbers in cell culture have not
yet been worked out.
This is an important distinction,
as large numbers of cells
are needed for stem cell replacement therapies.
National Institutes of Health
Resource for Stem Cell Research
http://stemcells.nih.gov/

Dr. Elias Zerhouni,

The Director of the National Institutes of Health,
told the Senate that,
due to the former administrations policy,
scientists in the United States were
trying to do their work
with one hand behind our backs.
Center for American Progress

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The current administration lifted the ban

on embryonic stem cell research
within weeks of taking office.

What do Americans think

about this issue?

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=
Congress and the Senate passed legislation
to loosen federal funding
restrictions on medical research using
embryonic stem cells. (June,2007)

The former administration vetoed this legislation.

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In response to this veto,

our National Institutes of Health,
stated that embryonic stem cells offer the prospect
of having a renewable source of replacement cells
and tissues to treat Parkinson's
and Alzheimer's diseases,
spinal cord injury, stroke, burns, heart disease,
diabetes, osteoarthritis and rheumatoid arthritis
and other conditions.

NPR June 20th,2007

Reporting by Maria Godoy, Joe Palca and Beth Novey.

64% of Americans support providing

federal funds for
Embryonic Stem Cell research

Gallop Poll April 2007

www.gallup.com/poll/27898/Six-Americans-Favor...

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What has privately funded research using ESC

recently discovered?
March 2008: Researcher Mary J. C. Hendrix, M.D. of Northwestern University,
using ESC, discovered a protein that prevents aggressive breast
cancer cells from metastasizing.
http://www.sciencedaily.com/

Feb. 2008: Scientists prodded human embryonic stem cells to

become functional pancreatic cells.
Gretchen Vogel. A Sweet Success for Embryonic
Stem Cells Science. Feb. 20. 2008

June 2007: Researchers at the University of Sheffield (U.K.) have grown

Retinal Pigment Epithelial (RPE) cells from embryonic stem cells
and have successfully used them to treat macular degeneration
in mice. AMD is the leading cause of blindness in humans.
ews.bbc.co.uk/1/hi/health/6721685.stm

April, 2004: Researchers regenerate an infarcted heart with ESCs.

The magnitude of myocardial regeneration obtained in this study
is significantly superior to that achieved with somatic marrow cells.
Lanza, R. et al. Regeneration of the infarcted heart with stem cells derived
by nuclear transplantation. Circ Res. 2004 Apr 2;94(6):820-7.

What will federal funding permit ESC research

to explore?

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Robert Klein,
Director of the California Institute for
Regenerative Medicine
The most immediate application for stem
cells will be to determine the toxicity of
potential pharmaceuticals. The reason stem
cells are needed is that testing the safety of
drugs in animals is notoriously unreliable.
Agents that seem safe in rodents are often
dangerous to humans.
Stem-cell-derived liver and heart cells will be
the first to be tested for the pharmaceutical
applications.

Lisa M. Krieger at Mercury News Silicon Valley. March 19th, 2008

http://www.mercurynews.com/breakingnews/ci_8630690

In the absence of
federal funds
for
ESC research or
federal regulation,
individual states have been forced
to regulate
and fund this research.

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June 25, 2004: New Jersey legislators pass a state budget that includes
$9.5 million for a newly chartered Stem Cell Institute of New Jersey.
The move makes New Jersey the first state to fund research on stem cells,
including those derived from human embryos.

Nov. 2, 2004: California voters approve Proposition 71, which

authorizes the state to spend $3 billion on embryonic stem-cell research
over 10 years. The measure is a response to federal funding restrictions
put into place in 2001.
It puts California ahead of the federal government and many
other nations in promoting the research.

May 31, 2005: Connecticut approves $100 million in funding for adult and
embryonic stem-cell research over the next 10 years.

July 13, 2005: In Illinois, Gov. Rod Blagojevich creates a stem-cell research
institute by executive order. The Public Health Department donates
$10 million to fund research.

June 15, 2005: Connecticut Govenor M. Jodi Rell signs a public act that
permits stem-cell research and bans human reproductive cloning. The act
appropriates another $20 million for conducting embryonic or human adult
stem-cell research.

April 6, 2006: Gov. Robert Ehrlich signs the Maryland Stem

Cell Research Act, which allocates $15 million for embryonic
stem-cell research grants.

Nov. 7, 2006: Missouri voters back a constitutional

amendment that safeguards embryonic stem-cell research
in the state. Missouri's legislature had been trying to ban such
research in the state.

Feb. 28, 2007: Iowa's Gov. Chet Culver signs legislation easing limits
on types of stem-cell research in Iowa. The new legislation allows
medical researchers to create embryonic stem cells through cloning.
While allowing for further research, it prohibits
reproductive cloning of humans.

March 16, 2007: After approving nearly $45 million for embryonic
stem-cell research in February 2007, California's stem cell agency authorizes
another $75.7 million to fund established scientists at 12 non-profit and
academic institutions.
NPR June 20th,2007
The research appears in the journals Cell and Science.
Reporting by Maria Godoy, Joe Palca and Beth Novey.

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To put this $$ into perspective:

The U.S. proposed budget for FY2009 is
$3.1 trillion
(with deficit > $400 billion)
($3,100,000,000,000.00)

The National Science Foundation

(NSF) proposed allocation is:

$6.9 billion
($6,900,000,000.00)
Of that, 679 million is to be allocated
$ 679 million
for Biological Research
$679,000,000.00)
The National Institutes of Health (NIH)
$29.5 billion
proposed allocation is:
($29,500,000,000.00)
of that, $28 billion will be allocated for medical research
Of that, $655 million funds stem cell research:
$203 million Human non-embryonic
$41 million Human embryonic (but only using HRSC lines)
AAAS Analysis of R&D in the FY 2009 Budget March 7, 2008 (REVISED) http://www.aaas.org/spp/rd/prev09p.htm
NIH Estimates of Funding at http://www.nih.gov/news/fundingresearchareas.htm

Is the controversy concerning the use of

stem cells obtained from blastocysts
a global issue?

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More than half of the worlds population, or 3.5 billion people,

live in countries which have a flexible or permissive policy
on embryonic stem cell research.
Conversely, all of these countries have banned
human reproductive cloning.
Those countries that are shaded yellow,
however, have restricted research using embryonic stem cells.

The black dots represent

Genome Sequencing Centers,
illustrating a strong commitment to
genomic research.
Hoffman, William The Stem Cell Dilemna
http://www.mbbnet.umn.edu/scmap.html

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Those regions with genomic sequencing centers also

have stem cell research centers

The paradox is that researchers in the U.S.

for years had access to state of the art,
multi-million dollar facilities,
but not the funding
to utilize them for ESC research.
www.mbbnet.umn.edu/scmap/scresearchmap.html

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Countries with stem cell

research centers and:
1. No federal legislation regarding HESC research
United States and Norway

2. Prohibition on derivation of HESCs:

Germany, Italy, Ireland
Germany, however, allows the importation of ESC lines developed prior to 2002
3. Legislation which permits but regulates the derivation
of HESCs from excess IVF embryos:
Australia, China, Brazil, Belgium, Canada, Denmark,
Czech Republic, Finland, France, Greece, Hungary, India,
Isreal, Japan, Mexico, Netherlands, Russia, Singapore,
South Africa*, Thailand, Malasia, Saudi Arabia, South Korea, Sweden,
Switzerland, Taiwan, United Kingdom
|Timothy A. Caulfield From human genes
International Consortium of Stem Cell Networks
http://www.stemcellcentre.edu.
au/PDF/Global_Regulation_HESC_Research_Oocyte_Donation.pdf
New challenges for patent law?
Trends in Biotechnology Volume 21 Issue
March, 20043

If ESC research is restricted due to the argument that

embryos are life and deserve protection,
one would expect to also
see regulation in other reproductive areas.
IVF results in the destruction of embryonic life.
The number of embryos produced through IVF is far
greater than the number required for clinical application.
However, IVF is available in some countries
where ESC research is restricted
The United States, although it did not for years fund ESC research
due to stated moral/ethical concerns, nonetheless, has
no IVF restrictions.
D.G. Jones and C.R. Towns
Navigating the Quagmire:
The Regulation of Human Embryonic Stem Cell Research
Human Reproduction 2006 21(5):1113-1116

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Is it ethically consistent
to deny researchers the
opportunity
to utilize discarded
embryos
but permit without review
the artificial creation
of surplus embryos for
IVF?

Which research counties restrict ESC use

and also restrict ART,
a somewhat ethically consistent policy

Italy
Restricted ESC research AND Restricted ART
Italy passed the Medically Assisted Reproduction Law in March 2004,
which prohibits the destruction of embryos created outside the body.
This means that all embryos created during IVF (to a legal maximum of three)
must be transferred to the womans womb. None can be stored or discarded.
http://docinthemachine.com/2007/04/19/embryoadoption

Germany
Restricted* ESC research AND Restricted ART
The Embryo Protection Act of 1990 in Germany states that no more
than three eggs can be collected from a patient for fertilization in vitro.
All embryos created must be transferred to the patient in order
to avoid any embryo freezing or destruction.
*allows the importation of ESC lines developed prior to 2002 (similar to US policy)
European Society for Human Reproduction and Embyology
http://www.eshre.com/emc.asp

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Even with Germanys and Italys

restrictive IVF legislation,
most IVF embryos
are not
able to implant
and wind up

Research countries
without
IVF restrictions
but with
a restrictive ESC research policy,
an inconsistent ethical policy:
Ireland
and the U.S.

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All human cells,

even individual sperm and eggs, are living.
The relevant question is when does personhood begin?
That's a valid theological or
philosophical question,
but from the scientific perspective,
this work holds enormous potential to save lives,
cure diseases, and improve the health
of millions of people.
The reality of the suffering
of those individuals far outweighs the
potential of blastocysts that would never be implanted
and allowed to come to term
even if we did not do this research."

Dr. Douglas Melton

The Harvard Stem Cell Institute,
Harvard University Gazette June 6, 2006
www.hno.harvard.edu/.../2006/06/06-stemcell.html

Therefore,
an ethically consistent
policy would favor
support for stem cell research which
utilized the inner cell mass
of blastocysts.

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Additional relevent topics for discussion

Society, Science and Ethics

1.Cord blood stem cells/cord blood banking:

Now becoming a HUGE, $$$ industry enrolling thousands of almost parentswill this
cord blood be available to all as in a blood bank or JUST for those with the resources to fund
their private tissue reserve? How long will these cryogenically preserved cells last?

2. SCNT: Somatic Cell Nuclear Transfer.

Embryos created for research use using egg cells and somatic nucleiwhere do THEY fall
in the ethics spectrum since they are not unique life? Similarly, what is the difference
between reproductive and therapeutic cloning?
Conversely, if iPS cells function as embryonic cells and can be induced to form a blastocyst,
would then this creation have the potential for sentient life as a clone?

3. Snowflake Program:
Named after President Bushs snowflake theme in his speech restricting ESC research,
this embryo adoption program has been touted by the administration and anti ESCgroups
as a being valid, alternative fate for the tens of thousands of wasted blastocycts.
To date: Over $1 million federal $ has resulted in just 16 adoptions

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