To Download - Stem Cells, Building Blocks for Tissue Engineering
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Transcript of To Download - Stem Cells, Building Blocks for Tissue Engineering
Life, Death, and Stem Cell Research
Richard L. Elliott, MD, PhD, FAPADirector, Medical Ethics
Professor, Internal Medicine
Mercer University School of Medicine
Adjunct Professor
Mercer University School of Law
Goals
Background– Timeline – Principles of medical ethics
Sources and fate of stem cells Potential therapeutic uses and abuses Access to results Ethics and IVF
– Preimplantation Genetic Determination– IVF, RU486, IUDs
Cloning
Recent Timeline
1978 Louise Brown IVF 1996 Dolly the sheep 1998 First human embryonic stem cells 2001 Federal funding for stem cell research limited to
existing stem cell lines 2004 South Korean researchers claim first human
cloned to generate stem cells 2007 Reprogramming of fibroblasts into stem cells 2009 Executive order reversed previous ban on
federal funding for new embryonic stem cell lines
Principles of Medical Ethics
Autonomy– Informed consent of gamete donors, parents
around fate of embryos Beneficence
– Potential therapeutic uses of hESC cell research Non-maleficence
– Harm to embryos Social justice
– Who will benefit? Will all have access to uses?
Sources of Stem Cells
Existing stem cell lines– Pre-2009 18 hESC lines approved for study using federal
funding Unused embryos from IVF
– 2010 43 approved hESC lines, 115 submitted for review. But only one line from pre-2009 lines approved thus far
Programmed adult skin cells (iPSC) Umbilical cord blood Amniotic fluid cells Bone marrow Fetal tissue Somatic cell nuclear transfer
In Vitro Fertilization
IVF – In Vitro Fertilization
Ethical Issues and IVF-Derived hESCs
Weighing harm to embryos vs potential benefits
Informed consent hESCs and personhood Federal funding for hESC research
Beneficence and Therapeutic Potential
First FDA-approved Clinical Trial Using hESCs
January 2009 Geron Spinal cord injury
Autonomy, NIH, Informed Consent, and hESCs
hESC derived from IVF for reproductive purposes
Available alternative uses explained No payments for embryos Care provided independent of decision Should avoid clinician/researcher same Donors gave voluntary written consent to use
embryos for research
NIH, Informed Consent, and hESCs
Must provide information on:– Fate of embryos– Embryos may be kept for years– Research not intended as treatment for donor– What personal, potentially identifying information
would be available to researchers– That research might result in financial gain for
researchers, not donors
Non-maleficence and The Moral Status of the Embryo
When Does Life Begin?:Biological Landmarks
Day 1 Fertilization Day 4-5 Cells used for
hESC Day 7-10 Implantation Day 14 Primitive streak Weeks 18-20 Quickening Month 9 Delivery
The Moral Status of the Embryo:When is the early embryo fully human?
Aristotle and Aquinas: ensoulment with quickening
Catholic Church through 1591 – abortion before quickening not punishable
1869 - Pius IX - Excommunication for abortion at any stage of pregnancy
Multiple ethics panels concluded the embryo is a developing human deserving respect but not full rights and protections
Faith and Embryonic Stem Cell Research
Harris Poll 2005– 70% Americans favor, 19% oppose– 70% Catholics, 38% born-again Evangelicals favor
57% who oppose abortion favor embryonic stem cell research – “not in womb, not abortion”
O. Hatch – opposes abortion, favors hESC research Islam - no prohibition Judaism – no prohibition Hindus – unclear MUSM research – IVF acceptable across faiths
Embryos and the Law
Georgia Criminal Law: “unborn child” means a member of the species homo sapiens at any stage of development who is carried in the womb.
Roe v. Wade: "We need not resolve the difficult question of when life begins. When those trained in the respective disciplines of medicine, philosophy, and theology are unable to arrive at any consensus, the judiciary, at this point in the development of man's knowledge, is not in a position to speculate as to the answer.“ May abort up to time of fetal “viability”
Ethics, IVF, and Stem Cells
Does use of hESCs from IVF for procreation restrict research on cells from the poor?
Is it morally acceptable to use existing stem cell lines created from embryos?
Should gamete donors and potential parents have equal rights?– Who should determine fate?
Should Federal funds be used to derive new hESC lines for research?
What to do with leftover embryos?
Over 500,000 embryos in storage
$100-150/year What if donors don’t pay
for storage?
Access to Stem Cell Benefits
Stem Cell Fraud, Scams and non-FDA Approved Treatments
Cloned human
Offshore clinics
Non-FDA approved
Resources
[email protected] This presentation
– Medicine.mercer.edu – search medical ethics– “resources”
NIH resources on stem cell ethics– http://bioethics.od.nih.gov/stemcell.html
International Society for Stem Cell Research– http://www.isscr.org/public/ethics.htm
Supplemental Slides for Dr. Elliott
More Complete Timeline
1974 Congress bans all federally funded fetal tissue research Ethics Advisory Board established to set guidelines for
research on fetal tissue research on tissue derived from abortions. EAB recommends federally funded research into IVF
1981 EAB disbanded, effectively ends federal funding into research on embryonic stem cells
DHHS continues moratorium on federal funding despite 18-3 recommendation for federal funding by b Human Fetal Tissue Transplantation Research Panel
1993 Moratorium on federal funding lifted 1994 Moratorium reinstated
Preimplantation Genetic Testing
Sex selection Genetic “defects”
– Physical characteristics
Stem Cells and PEDs
Should results from stem cell research be used to enhance performance?– Human Growth hormone– Anabolic steroids– EPO
IVF, RU486, IUDs
RU486 as an emergency contraceptive and IUDs prevent implantation
Contraception vs abortion in preventing implantation
Compare unused (non-implanted) embryos from IVF with RU486 and IUDs ethically
Terminology
IVF Embryonic stem cells Totipotency, pluripotency Cloning
Cloning
Somatic Cell Nuclear transfer
Somatic Cell Nuclear Transfer
Generate stem cells with defective gene for research on disease, e.g., Parkinson’s
Use patient’s cells to generate stem cells to create tissue for transplantation that has similar immunological characteristics as patient
Hybrids Human cloning
Induced Pluripotent Stem cells
What are areas of ethical concern?
Source and fate of stem cells Potential therapeutic uses and abuses Access to results Ethics and IVF
– Preimplantation Genetic Determination– IVF, RU486, IUDs
Cloning
NIH Guidelines for Stem Cell Lines
Pre-2009 18 hESC lines approved for study using federal funding
2010 43 approved hESC lines, 115 submitted for review. But only one line from pre-2009 lines approved thus far
