STEM

STEM CELLS
CELLS
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BIO
BIOETHICS
ETHICS
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 PROGRESS IN
MEDICAL TECHNOLOGY

It was triggered by the ability of under-

standing genetics.
It uses a lot of advanced in imaging, com-
puting and telecommunication.

Modern technology was founded for thera-

peutic and diagnostic needs.
Some medical paradoxes then appears !!!
 PARADOX OF MODERN MEDICINE
1. Modern medicine makes it possible.
2. Modern medicine tries to cure non-
illnesses.
3. It identifies asymptomatic medical cinditi-
ons as diseases.
4. Sometimes it even classifies risks as
diseases.
In general, it tends to blur the distinction bet-
ween diseases and risks !!!
(Prof. John
Ladd)
 MEDICAL TECHNOLOGY
Needs a process that’s just understand well by the
scientist.
Public suspicious often comes about the truth of
the information and independency of the scientist.

The suspicious appears because of the exact and

absolute answer can not been given by scientists.
The scientists themselves have some limitation or
even incapability to eliminate every risk element.
The suspicious increased because in reality, the
technology is under-controlled by multinational
company.
 MEDICAL TECHNOLOGY

1. Give chances to create technological com-

pulsion, that is, “if we can do it, let’s do it”.
2. Then, ethical and law problems appear.
3. “The slippery slope argument” may come
to try to solve ethical and law problems.
4. So, needed ethics and law discussion to
something that technically not a problem.
 THE POSITION OF

MEDICAL SCIENTISTS IN SOCIETY

It’s very important, because only the scientists who can
analyze the potential of benefits and risks.
They have an ethical duty to make a fair & open analysis.
But, the final decision must not been given fully to
them (scientists), because science monopoly does not mean
ethics and wisdom monopoly.
Also can not been given to the patient himself because bias of
interest can influence in making decision.
The society’s position is important too, so needed com-
munication and opinion building about the very sensitive topics.
 BIOTECHNOLOGY
Some people use the term only to refer to newer
tools of genetic science.

In this context, biotech may be defined as the use of

biotechnical methods to modify the genetic materials
of living cells so they will produce new substances
or perform new functions.
Examples include recombinant DNA technology, in
which a copy of a piece of DNA containing one or a
few genes is transferred between organisms or
"recombined" within an organism.
Biotechnology is any technological application that
uses biological systems, living organisms, or
derivatives thereof, to make or modify products or
processes for specific use.
(the UN Convention on Biological Diversity)
 APPLICATION
RED BIOTECH
Biotech applied to medical processes:
- organism designed to produce antibiotic.
- engineering genetic cures to diseases
through genomic manipulation.
WHITE (GREY) BIOTECH
Biotech applied to industrial processes:
- organism designed to produce useful
chemical.
GREEN BIOTECH
Biotech applied to agricultural processes:
- organism designed to grow under specific
environmental conditions.
- plant engineered to express a pesticide,
thereby eliminating the need for external
application of pesticide.
BLUE BIOTECH
- to describe the marine or aquatic aplication.
 ASPECTS OF
MEDICAL PRACTICES
GENETIC BASIS OF DISEASES
The number of diseases known to have a genetic
component has increased significantly in recent
years, includes:
- cardiovascular disease. - diabetes.
- stroke. - Parkinson’s disease.
- obesity. - Alzheimer’s disease.
- hypertension, etc.
DISEASE DISCOVERY & DIAGNOSIS
One direct clinical impact of the reported
progress in the discovery of disease gene is the
development of gene or DNA-based diagnostic
tests for the respective genetic disorders.

DRUGE DEVELOPMENT AND THERAPY

- Pharmacogenomics.
- Gene therapy.
ETHICAL, LEGAL AND SOCIAL ISSUES
PHARMACOGENOMICS (1)
1. Pharmacogenomics is concerned with individu-
al response to drugs based on genetic make-up.
2. Actual patient response (including processing
and metabolization of drug and any adverse
side effects) is largely determined by genetic
inheritance.
3. Understanding these processes through
genetic analysis of individual patient is likely to
lead to more effectve treatment and improved
drug development.
PHARMACOGENOMICS (2)
1. Treatment could be tailor-made for the patient,
resulting in :
a. faster recovery.
b. more cost-effective use of drugs.
c. decrease in adverse reactions to some drugs.

2. Genetic analysis of individuals, and ready

access to a wide range of drug options, will of
course be prerequisites for taking advantage of
the opportunities offered.
GENE THERAPY
Gene therapy involves the genetic engineering of patient’s
genetic code to removed or replace a mutant gene that is
causing disease.
1. Germ-line, or stem-cell gene therapy.
It involves altering a patient’s DNA in their stem cell.
The modification to their genetic blueprint is permanent
and hereditary.
This type of gene therapy is complex, and is considered
too risky to undertake until the underlying biology is
better understood.
It also rises many ethical problems, for example the po-
tential misuse of the therapy to create designer babies.
2. Somatic gene therapy.
This involves engineering cell on localized
basis, without affecting the patients basic ge-
netic blueprint.
Such therapy was approved in 1990 to treat a
four years old child suffering from severe
combined immune deficiency.
Some of the child’s white blood cells were
extracted, genetically engineered in the labo-
ratory and infused back into her bloodstream.
 STEM CELLS
Stem cells = single cells that can regenerate
and turn themselves into several types of spe-
cialized cells.
They come from:
- adult tissues;
- embryonic cells; and
- umbilical cord blood.
(Lewis M A; Tamparo C D; 2007)
Pluripotent = capable of giving rise to most
tissues of an organism.
Totipotent = having unlimited capability.
(Ruse, M & Pynes, C, A;
2006)
 GOALS

IN MIND
Several differentOF RESEARCHERS
goals in mind:
a. To use stem cells as the basis of new
therapies for those with serious deseases.
b. To gain increased understanding of the
processes of human development.
c. To provide new ways to test drugs for
efficacy, toxicity, and safety.
(Cohen, C, B; 2007)
 THERAPEUTIC USES OF STEM CELLS
1. Current Therapeutic Appiclations:
- Blood and Immune System Disorders.
- Metabolic diseases.
2. Experimental Therapeutic Applications:
- Multiple Sclerosis.
3. Potential Therapeutic Applications:
- Parkinson’s Disease. - Spinal Cord Injury.
- Retinal Degeneration. - Type I Diabetes.
- Cardiovascular Disease. - Metabolic Disease.
- Osteoporosis.
4. Avoiding or Overcoming Immune Rejection in Stem
Cell Transplantation:
- Immunosuppression.
- HLA Matching.
- Somatic Cell Nuclear Transfer.
- Induction of Immune Tolerance.
- Expansion of Autologous Transplantion.

(Monroe KR, Miller RB, Tobis JS; 2008)

 SCIENTIFIC ISSUES
ARISING IN STEM CELLS THERAPY

1. Use of Animal Cells or Product.

2. Quantitative and Qualitative Limitation of Adult
Stem Cells.
3. Tumor-Forming Potential of Embryonic Stem
Cells.
4. Assessing the Genetic Normality of Embryonic
Stem Cells.
(Monroe KR, Miller RB, Tobis JS; 2008)
 SIX POLICY OPTIONS

Op. 1: No human embryo research is permitted,

and no explicit permission is given to per-
form research on existing HESCs.
Op. 2: Research is permitted only on existing
HESC lines, not on human embryos.
Op. 3: Research is permitted only on remaining
embryos no longer needed for reproduction.
Op. 4: Research is permitted both on remaining
embryos and on embryos created specifical-
ly for research purposes through in vitro
fertilization.
Op. 5: Research is permitted both on remaining
embryos and on embryos created specifical-
ly for reseach purposes through somatic
cell nuclear transfer into human eggs or zy-
gotes.
Op. 6: Research is permitted only on remaining
embryos and on embryos created specifical-
ly for research purposes through the
transfer of human somatic cell nuclei into
nonhuman animal eggs, for example, rabbit
eggs.
(Ruse M & Pynes C; 2006)
 ETHICAL ISSUES (1)
The complex ways in transplanted stem cells may benefit the
patient.
Clinical trial being stated and stem cell treatment program being
offered without any clinical trials, involving trans-plantation of
stem cells with very little knowledge of wether the treatment will
work or about the mechanisms of any effect that does occur.
At least five company are offering stem cell therapies in
countries where regulations governing experimental proce-
dures area less stringent than in the United State.
This is bypassing the generally acceppted goals of clinical trials
to show, first, that the proposed treatment does not cause
harm, and, second, that it is effective.
 ETHICAL ISSUES (2)
Similar ethical issues have arisen in many other areas of
medicine, since the precise mechanism of many therapies,
especially pharmaceutical ones, is incompletely under-stood.
However, the issue is heightened in the case of cell-based
therapies, since the mechanisms of action are likely to be much
more complicated than is the case for more conventi- onal
therapies, since reversing the transplantation may not be
possible, and since cell-based therapies are being pro-moted as
a potential solution for many major injures and devastating,
proggressive, and otherwise in curable diseases.
 ETHICAL ISSUES (3)
In these cases the patients and their families can be desperate
enough to try innovative, risky, and expensive approaches with
very little proof that they will be helpfull.
It is difficult to deny them this one glimmer of hope.
However, lessons from gene therapy story show that the hasty
application of innovative therapies can be disas-trously harmfull
to the patient and counterproductive for the field.
(Glilley and Gee 2003; Rubanyi 2001; Somia and Verma 2000)
 ETHICAL ISSUES (4)

Finally,
with regard to the level of optimism that has been
generated over the potential of stem cell therapies to
cure deseases and heal injuries, it is important that
from time to time a realistic appraisal of this optimism
be made.
As an example, spinal cord injury has been in the
spotlight as one of the nervous system injuries that
could be best benefit from stem cell therapies.
(Mc Donald et al. 1999)
 LEGAL & ETHICAL IMPLICATION
OF TISSUE CELL RESEARCH

It is difficult to identify all the legal and ethical

implications of tissue research.
There are more questions than answers !!!
In some cultures and countries, human cloning of any
form is forbidden.
Other culturs and countries are more eager to step
into the arena, always pushing science fur-ther into
the future.
(Lewis M A; Tamparo C D; 2007)
 THE QUESTIONS
Who monitors fraudulent or false research results?
Should there be an international advisory group of
scientists and ethicists to help determine how tissue
research should move forward?
If funding for tissue research comes mostly from
private entities, who will claim ownership to the
results?
If tissue research has the potential for curing even
ene devastating disease, why would we not run as
fast as possible toward a successful result?
(Lewis M A; Tamparo C D; 2007)
 CLINICAL TRANSLATION

From laboratory to clinic:

1. Safety;
2. Potenstial benefit;
3. Design; and
4. Informed consent.
(Marhaen, 2009)
 PRECAUTIONARY PRINCIPLE
There are two broad classes:
 The Strong Precautionary Principle:
Take no action unless you are certain that it
will do no harm.
 The Weak Precautionary Principle :
Lack of full certainty is not justification for
preventing an action that might be harmful.
Both types are problematic, although the latter
considerably less so than the former.
(International Consumers for Civil Society)
 CRITICISMS OF STRONG PP
 Preventing (or attempting to prevent) some action that
might lead to the death of human beings may itself result
in the death of all human beings.
 Demanding that a technology should not be admitted untill
it has been proved to be harmless is equivalent to
requiring an infinitely high standard of proof ---- which can
never be achieved.
 The notion that regulations should be based on the
presumption that there is no safe dose for any chemical
that exhibits harmful properties at some dose has been
widely refuted.
 Applied generally, the strong precautionary principle
would end civilization.
(International Consumers for Civil Society)
 WORLDWIDE REGULATION
ON CLONING

Reproductive Cloning:
- Universally opposed (most are guided by ethical
rather than legal considerations).
- Human reproductive cloning and inherritable
genetic modification are illegal in >50 countries.
Therapuetic Cloning:
- Rather devided.
- Country like Australia, China, Thailand, Vietnam,
and India allowes this. (A Rahman A Jamal, 2009)
 KEY POINTS OF MALAYSIAN GUIDLINE

Source of stem cells:

- Creation of embryos for the sole purposes of
stem cells research is not allowed.
- Ban on reproductive cloning.
- Use of leftover embryos from invitro fertilization
is allowed with consent from the donor and the
relevant regulatories (consistent also with
Fatwa).
- Use of adult cells and commercial stem cell line
is allowed.
(A Rahman A Jamal, 2009)
Xenotransplantation:
- This is not allowed untill more scientific
and clinical evidence is obtained.
- Clinical trials shall be allowed only when
there are preclinical data indicating a high
probability of benefit to the recipients and
data on safety.
(A Rahman A Jamal, 2009)
 APPLICATION of
MEDICAL TECHNOLOGY
1. Respect to life and living.
2. Respect to human dignity and their
rights.
2. Equality between risk and advantage.
3. Awareness that ethics were not as
simple as the nature.
 MORAL PRINCIPLES
Beauchamp, Childress:
1. Beneficence.
2. Non-maleficence.
3. Autonomy.
4. Justice.
Catalano, J, T, 1991):
1. Autonomy.
2. Justice.
3. Fidelity.
4. Beneficence.
 SUMMARY
• Bioethics refers to the ethical implications
of biomedical technology and its practice.
• The change in ethics related to modern
medicine and research in the past few
decades is most intriguing.
• Medicine & technology rapidly change and
offer choices to clients and their families.
• Consumers are actively involved in their
health care and more knowledgeable of
medical technology and its implications.
• The public evaluates this technology and
how it relates the daily lives.
• The application of bioethics in our every-
day lives provides:
- opportunities;
- challenges;
- enthusiasm; and
- choices;
albeit difficult for each of us.