Ethical and Regulatory Challenges of Stem Cell Research and

Ethical and Regulatory
Challenges of Stem Cell Research
and Applications at Health Care
System in UAE
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Contents





Background
Objectives
Methods
Findings
Conclusions and recommendations
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Stem Cell

Stem cells are the basic building blocks of life
that are capable of developing into various
types of cells.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Sources



Embryonic: approximately four to five days
old in humans and consisting of 50–150 cells.
Fetal, amniotic
Adult: bone marrow, the bloodstream
(peripheral blood), and umbilical cord blood
from newborns.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Research and Applications


Stem cell research is picking up these days,
and it gives many patients new hope of
recover from their diseases.
Stem cell therapy has proven to be effective
for organs and tissues restoration, and for
fight against the incurable and obstinate
diseases.
Dr. Waleed Al Faisal & Dr. Hamid Hussain

Investment in stem cell is extremely effective
and productive in terms of cure of more than
70 serious illness
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Background



As the most advanced technology, Stem Cell
Transplants is performed by countries all over
the world.
In China, various kidney diseases are
treated, such as Diabetes Mellitus, Nephritis,
Renal failure, etc, with stem cells.
.
Dr. Waleed Al Faisal & Dr. Hamid Hussain

More than 85% of the patients treated by
stem cell can get obviously improvement
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Background

Stem cell research and applications is quite
debatable area due to:


Religious and ethical issues
Inadequate regulation and standards governing
this vital and rapidly expanded trend
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Objectives



To describe stem cell research and
applications status in UAE health care
system
To address ethics and regulations issue in
UAE health care system
To identify gaps in ethics and regulations
(Challenges)
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Methods


Current situation analysis of the status of
stem cell research and applications through
reviewing stem cell literature in UAE.
Assessing religious and ethical debates
Dr. Waleed Al Faisal & Dr. Hamid Hussain


Assessing ethical protocols of stem cell
functioning facilities
Revising currently operating standards and
guidelines regulating stem cell in health care
system in Dubai
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Findings
Stem cell research and
applications
Dr. Waleed Al Faisal & Dr. Hamid Hussain
UAE contribution

UAE produces 0.8% of the total Publications
of stem cell research in the Middle East

It is the third ranking among Arab countries
in stem cell research after Saudi and Egypt.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Publications of UAE compared to Middle east
countries having high numbers of publications
65.4
70
60
50
UAE
Turkey
Iran
Others
40
30
23.1
20
10
11.7
0.8
0
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Publications of UAE compared to
other Middle east and Arab countries
2.5
Saudi Arabia
Egypt
UAE
Pakistan
Lebanon
Tunisia
Kuwait
Moroco
Jordan
2
1.5
1
0.8
0.5
0
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Publications of UAE compared to
other Arab countries
40
35
Saudi Arabia
Egypt
UAE
Lebanon
Tunisia
Kuwait
Morocco
Jordan
30
25
20
15
11.5
10
5
0
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Distribution of stem cell
applications at UAE
Application of stem cell activities targets in UAE
60
50
40
30
20
10
0
51.6
32.4
others
S1
mouse
Human
16
percentage
Series1
Target
Series1
Human
mouse
others
51.6
32.4
16
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Distribution of stem cell applications according to
the target population in UAE
Distribution of stem cell applications and
research in UAE
49.3
39.7
S1
Postnatal/cord
Typeof
application
Embryo/Fetal
20
Adults
50
40
30
20
10
0
percentage
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Series1

Stem cell applications are still restricted to
minor issues in Dubai and have no major
applications as due to barriers of ethical
origin.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
UAE stem cell bank

The UAE Department of Health and Medical
Services is creating a stem cell bank to
harvest cells from UAE nationals and
expatriates for a variety of clinical
applications, according to the organisers of
Arab Health 2006.
Dr. Waleed Al Faisal & Dr. Hamid Hussain

The cell bank could be used to treat
conditions such as heart disease, anaemia,
Hodgkin's disease and thalassemia, which is
particularly prevalent in the UAE.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
DHA

Dubai Cord Blood and research center
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Treatments

The first Stem Cell Treatment centers of the
Middle East is set up in Dubai, and it focus on
treatments such as plastic surgery, while
other center based in Abu Dhabi mainly
conduct major surgery and research into the
treatment of diseases such as Diabetes.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Laws and Ethics
Dr. Waleed Al Faisal & Dr. Hamid Hussain
In the Middle East


In the majority of the region, there is no legal
framework regulating stem cell research
Scientists often rely on religious decrees
outlining acceptable practices
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Code of Ethics
Healthcare Professions
UAE, MoH
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Medical Professionals


Engage in research activities consistent with the
particular health care needs of the community.
Ensure that any research activity participated in is:





Evaluated for scientific soundness.
Approved by the appropriate ethics committee.
Is sufficiently planned and supervised to protect subjects
from harm.
Anonymity of subjects is protected in the reporting of
research results.
Results of all research are reported truthfully and published
when possible.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Sources of ethical cods of stem cell in UAE
60%
50%
Islamic
40%
perctentages 30% approach , 60% International
20%
benchmarking , Local regulation
10%
25%
, 15%
0%
Islamic
International
Local
approach
benchmarking
regulation
Sources
Series1
Dr. Waleed Al Faisal & Dr. Hamid Hussain

more than 60% of ethical approach derived
from Islamic approach,
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Stem Cell codes of Ethics in
UAE:
1. Islamic approach
It comes within the Islamic philosophy context
which always encouraged scientific research,
particularly research directed toward finding
cures for human disease.

Dr. Waleed Al Faisal & Dr. Hamid Hussain

Based on the expectation of potential
benefits, Islamic teachings permit and
support human embryonic stem cell research.
The majority of Muslim scholars also support
therapeutic cloning.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
The early pre-embryos are considered in
Islamic jurisprudence as worthy of respect but
do not have the full sanctity offered to the
embryo after implantation in the uterus and
especially after ensoulment

Dr. Waleed Al Faisal & Dr. Hamid Hussain

This permissibility is conditional on the use of
supernumerary early pre-embryos which are
obtained during infertility treatment in vitro
fertilization (IVF) clinics.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
2. other sources of ethical
codes


only 25% from international benchmarking
and 15% from National regulations.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Regulations
Dr. Waleed Al Faisal & Dr. Hamid Hussain

there is still significant challenges in setting
up proper approaches, attitudes as( 4
)regulatory bodies available in UAE (HAAD,
DHA, DHCC, MOH) as they all:
achieve less than 30% of regulation
development
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Figure (7) Distribution of stem
cell regulatory bodies in UAE.
Regulatory bodies of stem cell in UAE
40%
35%
30%
25%
20%
15%
10%
5%
0%
Series1
Series2
Haad
DHA
S2
S1
DHCC
Health authorities
MOH
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Regulation
progress level
3.Regulation Codes

Regulation policy of stem cell is on the
agenda of regulation body in health care
system in Dubai, and it was given a priority
within short term goals to be fully developed
within the coming two years,
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Challenges
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Challenges of stem cell
applications and research in UAE.
Challenges for stem cell application and
research in UAE
S1
research tool
type of
challenges
infrastructure
Regulation
50%
40%
40%45%
30%
30%
20% 15%
25%
10%
0%
Dr. Waleed Al Faisal & Dr. Hamid Hussain
percentage
Series1
Conclusions
Dr. Waleed Al Faisal & Dr. Hamid Hussain

Private and governmental stakeholders and
effort are not yet gathering, focusing and
developing major investment in stem cell
applications and codes of ethical practices.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Conclusions


Stem cell research and applications are still
not institutionalized and individual base.
The Current infra structure of stem cell
applications is still primitive and not well
developed, yet significant steps has been
threw recently
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Conclusion


UAE health care system is still at its earlier
stages in developing stem cell code of ethics
and regulatory guideline. Clear vision,
mission, objectives and values are in need to
be also developed.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Recommendations


Stem cell research in Dubai is in need for
further development, calibration and quality
assurance
Stem cell research and applications are in
need to be institutionalized
Dr. Waleed Al Faisal & Dr. Hamid Hussain
Recommendations


Establishing national task force of experts
for developing solid code of ethics and
regulations, and filing major gaps.
Developing national code of conducts
tailored and oriented to the cultural
specifications in Dubai
Dr. Waleed Al Faisal & Dr. Hamid Hussain

Benchmarking with international best
practice within the national context , needs
and developments
Dr. Waleed Al Faisal & Dr. Hamid Hussain
References


1. El-Awady, N. January 17, 2008. Gulf
States embrace stem cell technologies at
home and abroad. Nature Reports Stem
Cells.
2. Gottweis, H., Salter, B., and Waldby, C.
2009. The Global Politics of Human
Embryonic Stem Cell Science. Palgrave
MacMillan, New York.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
References


3. Isasi, RM. 2009. Policy Interoperability in Stem
Cell Research: Demystifying Harmonization. Stem
Cell Reviews and Reports 5(2): 108-115.
4. Kristin R. W. Matthews, and Neal F. Lane. Baker
Institute Policy Report, Science Collaboration across
Borders, 2009. Available on:
www.bakerinstitute.org/publications/ST-pubPolicyReport42-081809.pdf/view. Accessed on
Tuesday the 10th of July 2012.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
References


5. MoH, UAE, Code of Ethics, Healthcare
Professions, 2001.
6. Jesse M. Flynn and Kirstin R. W.
Matthews. Stem Cell Research in the
Greater Middle East: The Importance of
Establishing Policy and Ethics
Interoperability to Foster International
Collaborations. Stem Cell Reviews and
Reports. June 2010, Volume 6, Issue 2, pp
143-150
Dr. Waleed Al Faisal & Dr. Hamid Hussain

Lori P. Knowles. Religion and Stem Cell
Research. Available on:
http://www.stemcellschool.org/pdf/Religionand-Stem-Cell-Research.pdf. Accessed on
Thursday the 19th of July 2012.
Dr. Waleed Al Faisal & Dr. Hamid Hussain
THANK YOU
Dr. Waleed Al Faisal & Dr. Hamid Hussain