2. QUESTION:
Should stem cell research be funded by the government or through public and/or
private funding?
3. History
Stem cells are cells found in all multi-cellular
organisms, which includes humans.
They were first isolated in mice in 1981 and in
humans in 1988.
4. Stem Cells Research
Embryonic cells have the ability to develop into
virtually any cell in the body, and have the
potential to treat medical conditions such as
diabetes and Parkinson’s disease.
5. Stem Cell Research cont.
Some have argued that adult stem cells (from bone
marrow or umbilical cord blood) should be
pursued instead of embryonic cells because they
believe the derivation of stem cells from embryos
is ethically unacceptable.
6. Stem Cell Research cont.
Stem cells retain the ability to become some or all
of the more than 200 different cell types in the
body, and thereby play a critical role in repairing
organs and body tissues throughout life.
7. Stem Cell research cont.
Embryonic stem cells may have a greater ability to
become different types of body cells than adult
stem cells.
8. Embryonic stem cells from IVF Embryos or
fetal tissue
Embryonic stem cells were first isolated from
mouse embryos in 1981 and from primate embryos
in 1995.
Animal embryos were the only source for research
on embryonic stem cells until November 1998.
The cells were derived from five day old embryos
produced via in vitro fertilization. (IVF)
9. Cont.
This work is controversial because the stem cells
are located within the embryo and the process of
removing them destroys the embryo.
The cells have also been derived from the
properties from five-to nine week old embryos or
from fetuses obtained through elective abortion .
10. Embryonic Stem Cells Obtained via SCNT
(Cloning)
Another potential source of embryonic stem cells
is somatic cell nuclear transfer (SCNT), also
referred to as cloning.
Stem cells derived from cloned embryos may offer
the best hope for understanding and treating
disease.
The nucleus of the egg is removed and replaced by
the nucleus from a mature body cell, such as a skin
cell from a patient.
11. Stem Cells from Adult Tissue or Umbilical
Cord Blood
A January 2007 report found cells can be found in
amniotic fluid.
12. Potential Applications of Stem Cell Research
Stem cells provide the opportunity to study the
growth and differentiation of individual cells in
tissues. Understanding these processes could
provide insights into the causes of birth defects,
genetic abnormalities, and other disease states.
If normal development were better understood, it
might be possible to prevent or correct some of
these conditions.
13. Cont.
Stem cells can be used to produce large amounts of
one cell type, to test new drugs for effectiveness
and chemicals and toxicity.
Stem cells might be transplanted into the body
and treat disease (diabetes, Parkinson’s disease) or
injury (e.g., spinal cord)
14. Current Regulations
The Dickey Amendment
Prior to an August 2001 Bush Administration
decision, no federal funds had been used to
support research on stem cells derived from either
human embryos or fetal tissue.
15. Cont.
Under the amendment
(a) None of the funds made under the Dickey Act
may be used 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 or discarded, or knowingly
subjected to risk or injury or death greater than
that allowed for research on fetuses in utero.
16. Cont.
(b) The term ‘embryo or embryos’ includes any
organism, not protected as a human under 45 CFR
[the Human Subject Protection regulations} as of
the date of enactment of this Act, that is derived
by fertilization, parthenogenesis, cloning or any
other means from one or more human gametes
[sperm or egg] or human diploid cells {cells that
have two sets of chromosomes, such as somatic
cells]
17. Peter Griffin visits stem cell research lab
http://www.youtube.com/watch?feature=player_d
etailpage&v=TRtlkcQ6brE
18. Administration Policies
Clinton Administration Stem Bush Adminstration Stem Cell
cell Policy Policy
Research in which human stem cells are On August 9,2001, President Bush
utilized to create or contribute to a human announced for the first time federal
embryo
funds would be used to support
Research in which human cells are research on embryonic stem
combined with an animal embryo cells, but funding would be limited
Research in which human stem cells are to “existing stem cell lines where life
used for reproductive cloning of a human and death decisions had already
Research in which human stem cells are been made.
derived using somatic cell nuclear transfer
(1) with the informed consent of
Research utilizing human stem cells that donors
were derived using somatic cell nuclear
transfer (2) from excess embryos created
Research utilizing stem cells that were solely for reproductive purposes
derived from human embryos created for
research purposes, rather than for infertility (3) without any financial
treatment. inducements to the donors.
19. Administration Policies Cont…
In March of 2009 President Obama signed an
executive order repealing a Bush-era policy that
limited federal tax dollars for embryonic stem cell
research.
Obama’s repeal overturns an order signed by
President Bush in 2001 that barred the National
Institutes of Health from funding research on
embryonic stem cells beyond using 60 cell lines
that existed at the time.
20. Administration Policies cont..
Obama also signed a presidential memorandum
establishing greater independence for federal
science policies and programs.
Obama’s order directs the NIH to develop revised
guidelines on federal funding for embryonic stem
cell research within 120 days of the original
memorandum.
The federal Courts upheld Obama’s actions.
21. Federal Funds
Federal Funds would not be used for:
(1) the derivation or use of stem cell lines derived
from newly destroyed embryos.
(2) the creation of any human embryos for
research purposes
(3) the cloning of human embryos for any purpose.
22. Regulation of Stem Cell Research
NIH Research funding and
FDA Regulation Stem Cell Registry.
The FDA defines “xenotransplantation” as
any procedure that involves the
tranpltation, implantation, or infusion into
a human recipient of either
(a) live cells, tissues, or organs from a
nonhuman source
(b) human body fluids, cells, tissues or
organs that have had ex vivo contact with
nonhuman animal cells, tissues or organs.
Under FDA guidelines, transplantation
therapy involving Bush approved stem cell
lines, which have all been exposed to
mouse feeder cells, would constitute
xenotransplantation.
23. Private vs. Public Funding
Public Funding Private Funding
Public funding can An advantage of private
contribute to sound funding is that it allows
policy by increasing the research to proceed even
probability that the if it’s a politically touchy
issue.
results of stem cell
(In the US, only private
research will reflect
funded companies are
social priorities that may
allowed to perform
not inform research in research on embryonic
the private sector. or fetal stem cells)
24. Private vs. Public Funding cont.
Public Funding Private Funding
Many Americans including The private sector can
children are excluded from
the U.S. health care compensate for
system. Public funding fluctuations in
offer s the best hope of
fostering public government
consideration for common spending, and more
good, rather than
marketplace concerns, and importantly, and can
of expanding access to the move forward without
fruits of stem cell research
for a large number of any federal funding.
Americans.
25. Private vs. Public Funding cont.
Public Funding Private Funding
Stem cell research is more Privately funded
likely to advance if
canonical genetic stokes of lavatories have made
ES cells are made available large technical
to the scientific
community. Public advancement s in stem
funding under the auspices cell research.
of federal agencies is the
only effective means for
ensuring equal access by
scientists to standardized
ES cell lines
26. Federal Funding
The federal government is the only realistic source
for such an infusion of funds.
The government can strictly monitor the practices
of public research through federal funding.
The commitment of federal funds also offer a basis
for public review, approval and, in monitoring
through well established procedures that will
promise the public’s interest in ensuring that stem
cell research is conducted in a way that is both
scientifically rigorous and ethically proper.
27. Recommendations
Recommendation (1)
Federal funding for stem cell research is necessary
in order to promote investment in this promising
line of research, to encourage sound public policy,
and to foster public confidence in the conduct of
such research.
Realizing the potential health benefits of stem cell
technology will require a large and sustained
investment in research. The federal government is the
only realistic source for such infusion of funds.
28. Recommendation (2)
Public funding should be provided for embryonic stem cell
research, but not at this time for activities involved in the
isolation of embryonic stem cells, for which there remains
continuing debate. This approach will allow publically-
funded researchers to move more quickly toward
discoveries that will lead to alleviating the suffering caused
by human disease.
Although the derivation of human stem cells can be done in an
ethical manner, there is enough objection to the process of
deriving stem cells in a ethical manner, to recommend against
its public funding. Further for the foreseeable future there will
be sufficient material isolated by researchers not using public
funding that this exclusion will not have a negative impact on
research.
29. Recommendation (3)
The formation of company-based independent ethics
advisory boards should be encouraged in the private
sector.
Private sector research has played a crucial part in the
advancement of research on stem cells. The leadership
exhibited by the company that has sponsored all of the
published human embryonic and germ cell research to
date in establishing an external Ethics Advisory Board to
develop guidelines for ethical conduct of such research is
positive. While these private sector boards are not a
substitute for public oversight and guidance, they can be a
positive influence on the way that industry-funded stem
cell research proceeds.