2012Marek Vácha

There is a growing gulf between what medicine can do and what the health service can afford.

Richard Gardner, chair of the Royal Society´s working group on stem cells and therapeutical cloning

Embryonic Stem CellsES cells that have proliferated in cell culture for 6 or more months without differentiating, and which have pluripotent and appear genetically normal, are referred to as an embryonic stem cell line.

each of early blastomeres (2,4,8 cell stage) is thought to be able to form an entire embryo, including the trophoblast

isolated ICM cells probably cannot form the trophoblast cells

1975 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued its report and recommendations for research on the human fetus no federal monies should be used for IVF of human eggs

until a special Ethics Advisory Board reviewed the ethical issues

1994 NIH established the Human Embryo Research Panel some areas of human embryo research be acceptable for

federal funding, including research on embryos created expressly for the purposes of research

however, president Clinton directed NIH not to allocate resources to "support the creation of human embryos for research purposes"

tough his directives said nothing about reseach involving spare embryos

1994 Congress stopped the enterprise dead in its tracks

by enacting an amendment to the omnibus appropriations bills that prohibited NIH from using federal funds for any and all research on human embryos.

1998 NIH attorneys ruled that the prohibiting law

actually permitted federal funding of research on the embryonic stem cell lines, provided that the researchers were not themselves responsible for the acts of embryo destruction needed to produce them.

2000 After a study by the National Bioethics

Advisory Commission supported such research, and after the NIH developed guidelines for it, President Clinton authorized such funding

august 2001 The federal government would agree to fund

embryonic stem cell research only on already existing stem cell lines, but there would be any further destruction of human embryos

August 2000: scientists could apply for federal funding only for research utilizing 78 existing stem cell lines. the true number of available and suitable lines

appears to be closer to twenty than the higher number.

President Bush agreed to finance embryonic stem cell research, but limited federally financed research to 21 cell lines already in existence by 2001.

Kass, L.R., (2002) Life, Liberty and the Defense of Dignity. Encounter Books, New York, London. p. 81 - 85

the restriction do not hamper the use of private funds for the other lines, only federal funds

09/03/2009 president Obama releases federal funds

http://edition.cnn.com/video/#/video/offbeat/2009/03/12/moos.sesame.street.layoffs.cnn

23/08/2010 A federal district judge blocked President Obama’s 2009 executive order that expanded embryonic stem cell research, saying it violated a ban on federal money being used to destroy embryos.

With the case back in his court, Judge Lamberth ruled that the administration’s policy violated the clear language of the Dickey-Wicker Amendment, a law passed annually by Congress that bans federal financing for any “research in which a human embryo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death.”

The Obama administration said that its rules abided by the Dickey-Wicker Amendment because the federal money would be used only once the embryonic stem cells were created but would not finance the process by which embryos were destroyed. The judge disagreed, writing that embryonic stem cell research “necessarily depends upon the destruction of a human embryo.”

http://www.nytimes.com/2010/08/24/health/policy/24stem.html?pagewanted=2&_r=1&ref=science

the appellate court said that because the law is written in the present tense, “it does not extend to past actions.” Judge Karen LeCraft

Henderson, the dissenter in Friday’s appeals court ruling, wrote that her colleagues “perform linguistic jujitsu” to arrive at their conclusion.

The plain language of the law bans financing for all research that follows the destruction of embryos, she wrote, and it is meaningless to try to separate the process of destruction from the use of the stem cells that result from that destruction.

http://www.nytimes.com/2011/04/30/health/30stemcells.html

Embryonic Stem Cells

were firstly isolated from mice in1981.

Human Embryonic Stem Cells were firstly isolated in 1998 by

James Thomson (Wisconsin university funded by Geron corporation).

Dr. John Gearhart of Johns Hopkins University

James A. Thomson says he thought “long and hard” before doing stem cell research.

James A. Thomson (2007)

His laboratory was one of two that reported a new way to turn ordinary human skin cells into what appear to be embryonic stem cells without ever using a human embryo.

The fact is, Dr. Thomson said in an interview, he had ethical concerns about embryonic research from the outset, even though he knew that such research offered insights into human development and the potential for powerful new treatments for disease.

“If human embryonic stem cell research does not make you at least a little bit uncomfortable, you have not thought about it enough,” he said. “I thought long and hard about whether I would do it.”

James A. Thomson (2007)

Now with the new technique, which involves adding just four genes to ordinary adult skin cells, it will not be long, he says, before the stem cell wars are a distant memory. “A decade from now, this will be just a funny historical footnote,” Dr. Thomson said in the interview.

http://www.nytimes.com/2007/11/22/science/22stem.html?_r=1&ref=science&oref=slogin

Classification (ESC)Human embryonic stem cells,

Embryonic Stem Cell (ESC) Therapy - theoretically involves the use of cells extracted from a five day old in vitro fertilized embryo (in this embryo there is approximately 100 cells, ICM is 30 of them). ESCs have been scientifically substantiated to be pluripotent for all cell types.

(FSC)Human embryonic germ cells, Fetal Stem Cell (FSC) therapy involves the use of human fetuses

aborted between 1 and 3 months. Tissue with imbedded stem cells is scraped from the liver, neural or gonadal ridges. Commercial providers of these potentially pluripotent cell types do not scientifically classify the cell populations.

(ASC)Human Adult stem cells, ASC are undifferentiated, found among differentiated cell

types in a tissue or organ. ASC can renew themselves, and can differentiate to yield the major specialized cell types of the tissue or organ. Their primary role in a living organism is to maintain and repair the tissue in which they are found. There are approximately 20 types of ASC in the human body.

iPS

= induced pluripotent stem cells by addition of four human human genes to

human skin cells they can be reprogrammed back to the state of stem cells from an early embryo, with the abuility to develop into every cell type in the body

iPS

iPS thus promise to provide a source of immunologically compatible tissues for treating patients currently suffering from incurable genetic diseases such as Alzheimer´s disease, without encountering the ethical objections raised by using ESC from human embryos or cybrids

„In the long-term the scientific view is that it will be possible to re-programme adult stem cells with the full potential of embryonic cells but without the morally contestable need to create an embryo.“

Liam Donaldson, the Chief Medical Officer in the UK

Classification

totipotent cells pluripotent stem cells

pluripotent = "capable of becoming many things"

multipotent stem cells progenitor (=unipotent) stem cells

 can produce only one cell type

ASC

Embryonic Stem Cells

Embryonic Stem Cells

Possible Sources of Embryonic Stem Cells

Surplus embryos Embryos made exclusively in order to receive ESC SCNT = Therapeutic Cloning

Dr. Woo Suk Hwang

24/11 2005 Dr. Hwang is forced to to step down

female researchers in his own lab had supplied eggs for his research.

two key scientific papers in 2005, both published in Science Magazine, were found to have been fabricated.

August 2005 Snuppy, an Afghan hound was cloned by Dr. Hwang

Dr. Hwang

Dr Hwang was in March fired from his professorship at Seoul National University (SNU) and in May was charged with fraud and embezzlement. Dr Hwang had received millions of dollars' worth of funds from the state and private foundations for his research.

The downfall of Dr Hwang came as a big shock to Koreans, who had taken great pride in what appeared to be the pioneering work of the stem cell researchers at Seoul National University.

Dr Hwang at one point had 15,000 hard-core fans, who belonged to a "I love HWS" online community.

Definition of Human Embryo

A human embryo is a discrete entity that has arisen from either:

(i) the first mitotic division when fertilization of a human oocyte by a human sperm is complete or

(ii) any other process that initiates organized development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitivestreak appears,

and has not yet reached 8 weeks of development since the first mitotic division.

Arguments for obtaining Embryonic Stem Cells from embryos The prospects are beyond our scope Only 30-50% zygote implants. If Mother Nature

is so prodigal, we may not to bother with embryos.

individual is „in-dividium“, non-divisible. Human embryo is nothing than cluster of cells if we approved abortions, there is no discussion

about status of embryos utilitarianism: we have to consider the ethical

calculation, gains and losts: happy and healthy patient/destroyed embryo

Arguments for obtaining Embryonic Stem Cells from embryos If abortions are legal, protection of embryos

is inproportionate, inadequate ES cells are not embryos. These cells are no

more totipotent. If we already have these lines, they are cells, not embryos.

individuum is etymologically indivisible MZ twins could arise until the end of the second

week. Until this time we cannot speak about individuum

Arguments for obtaining Embryonic Stem Cells from embryos Argument of utilitarianism: on the one side

of the ethical scale is healthy happy patient, on the other side of the scale embryo which can not feel neither pain, nor pleasure

Arguments against obtainig Human Embryonic Stem Cells Embryo is not, embryos are. Every embryo

has a unique genetic design An Embryo has a potentiality to become an

adult human person, so we must treat an embryo as a person.

every embryo has two living beings, parents Aristotle: four „causes“ Immanuel Kant:

the problem of freedom difference between cost/value and dignity

Aristotle

causa materialis causa formalis causa efficiens causa finalis

Aristotle

causa materialis: „cluster of atoms“, „cluster of cells“, „C,H,O,N,“ etc.

causa formalis – form of living matter is a soul

causa efficiens „where from I came?“

causa finalis „what is goal of my life?“

„Cluster of cells“

Five day old embryo is composed from150 – 200 cells,adult human from 5. 1014 cells

Germany

The German Parliament established the 2002 Stem Cell Act, which allows the import of hESCs for high-ranking research objectives.

These must be evaluated by the Robert Koch Institute, a federal institute in Berlin, and its central ethics committee for stem-cell research (http://www.rki.de).

Moreover, only hESC lines produced from surplus embryos from in vitro fertilization (IVF) before 1 January 2002 can be legally imported. This key date was chosen to ensure that no hESC lines are directly produced for German research; in other words, that no human embryos are destroyed 'on German order'

Regulation of Research in  EU

Germany: prohibition to destroy embryos for obtaining hES. Allowance to work with hES if the lines were created before 01/01 2002

22/05 2008 this import and usage was shifted to 01/05 2007

http://www.nytimes.com/2008/12/04/us/04embryo.html?_r=1

Ms. Best said her nine embryos “have the potential to become beautiful people.”

The thought of giving them up for research “conjures all sorts of horrors, from Frankenstein to the Holocaust,” she said, adding that destroying them would be preferable.

Her teenage daughter favors letting another couple adopt the embryos, but, Ms. Best said, she would worry too much about “what kind of parents they were with, what kind of life they had.”

„Solutions that typically are not offered“ Smaller numbers of patients wished for

solutions that typically are not offered. Among them were holding a small ceremony

during the thawing and disposal of the embryos, or

having them placed in the woman’s body at a time in her cycle when she would probably not become pregnant, so that they would die naturally.

Some people pay storage fees for years and years.

Others stop paying and disappear, leaving the clinic to decide whether to maintain the embryos free or to get rid of them. “They would rather have you pull the trigger on

the embryos,” Dr. Sauer said. “It’s like, ‘I don’t want another baby, but I don’t have it in me; I have too much guilt to tell you what to do, to have them discarded.’ ”

SCNT

this technique is too elaborate, and hence too expensive for routine use

technique might be more properly called „research cloning“

Reproductive and Therapeutic Cloning

Human EmbryoLuis Santamaría, U.A.M., Spain

Human embryos are not: some other type of animal organism, like a pre-

human entity neither are they a part of an organism, like a heart,

a kidney, or a skin cells nor again are they a disorganized aggregate, a

mere clump of cells awaiting some magical transformations

rather, a human embryo is a whole living member of the species Homo sapiens in the earliest of his or her natural development

Embryo science, Embryo technology, Embryo ethicsLuis Santamaría, U.A.M., Spain Embryo science

tells us what the embryos are and when they begin

Embryo technologies represent the abilities of researchers to do

things to or with embryos they can make embryos in lab, by IVF or by

cloning they can keep embryos alive in the lab whether

in culture, or indefinitely by freezing they can destroy these embryos

Embryo science, Embryo technology, Embryo ethicsLuis Santamaría, U.A.M., Spain Embryo ethics

are such manipulation morally right? it is not uncommon to hear embryo

researchers claim that only science should have a say what science does, and that ethics, religion and politics have no business in the concerns of science

it is true that moral philosophy cannot say what embryo is nor has anything to say about what can be done with an embryo

Geoffrey Chu, 2003

Rasko correctly asserts that certain medical research is unethical and unjustifiable (i.e. Nazi experiments) and should always be prohibited, regardless of significant potential gains.

Accepting this premise renders utilitarian arguments in favour of ESC research irrelevant if the human embryo is considered to be an individual human being.

Utilitarian arguments have serious limitations because the eventual outcome of benefits and harms is initially uncertain and may remain unclear for a substantial period − decades or longer.

http://www3.interscience.wiley.com/journal/118897797/abstract?CRETRY=1&SRETRY=0

Geoffrey Chu, 2003

In the early phases of this continuum, we casually redefine 'human' to suit our personal agendas. (…) Emergence of the embryonic streak on day 14 is another unfortunate arbitrary definition of who is human.

Those who have lost part of their cortex from a stroke or Alzheimer's Disease are no less human than they were beforehand.

http://www3.interscience.wiley.com/journal/118897797/abstract?CRETRY=1&SRETRY=0

Cybrids

applications have been made by three teams of UK researchers to the HFEA for licences to use rabbit, cow and goat eggs to create cytoplasmatic hybrid embryos, so-called cybrids

the proposal, which has found widespread support in the bioscience community, was the subject of a public consultation exercise, which resulted in the HFEA giving „in principle“ approval for the use of the technique in 2007

Cybrids