International Policies on Stem Cell Research

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1 International Policies on Stem Cell Research Prof. Reza Nassiri Director, Institute of International Health Associate Dean of Global Health Programs College of Osteopathic Medicine Michigan State University Member, UNESCO Bioethics Conference on Ethics & Law of Stem Cell Research, June 4, 2011, Dong-A University Busan, Korea.

2 International Policies on Stem Cell Research Human stem cell research Embryonic Adult (somatic): Undifferentiated cells, found among differentiated cells in a tissue or organ that can renew themselves and can differentiate to yield some or all of the major specialized cell types of the tissue or organ. Primary role: to maintain and repair the tissue in which they are found.

3 Ethics STEM CELL RESEARCH Policies/ Regulations Related to the scientific and therapeutic relevance and integrity. Biology Preclinical safety issues To ensure patient accessibility to products and gov. assistance for their regulations & control. Therapeutic application

4 International Policies on Stem Cell Ethics Research Discussion of the bioethics of human stem cell research has transitioned from controversies over the source of human embryonic stem cells to concerns about the ethical use of stem cells in basic and clinical research.

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7 International Stem Cell Research The average citation number for SC article United Kingdom United Sates Japan 8.36 Germany 3.45 Source: Nature Reviews Molecular Cell Biol 10, 286 (April 2009)

8 U.S. Scientific Breakthrough November 1998 Dr. James A. Thompson, a biologist at the University of Wisconsin, first reported the isolation of human embryonic stem cells (hescs). Scientists hoped to find ways of using hescs to repair damaged tissue. Until 2001, no public funding was ever provided for hesc research in the U.S. President Bush: I oppose federal funding for SC research that involves destroying living human embryos.

9 May 24, 2005 United States The House of Representatives passed a bill to expand federal financing for embryonic stem cell research, defying a veto threat from President Bush. An identical bill has board bipartisan support in the U.S. Senate.

10 United States The Stem Cell Research Enhancement Act (SCREA) of 2005 Would ease current restrictions on federal funding for stem cell research by allowing the Secretary of Health and Human Services to conduct and support research on stem cells, regardless of the date on which they derived from a human embryo.

11 United States HR-2520, the Stem Cell Therapeutic & Research Act of Passed virtually unanimous decision by the House of Representatives. The Bill amended the Public Health Service Act to establish a National Cord Blood Stem Cell Bank Network to: Prepare, store and distribute human umbilical cord blood stem cells for the treatment of patients and to support peer-reviewed research using such cells. $19.4 M appropriation to collect cryopreserved cord blood SC units with extended funding over five years.

12 President Obama signs the executive order on stem cell policy at the White House (March 09, 2009) Today, with the Executive Order I am about to sign, we will bring the change that so many scientists and researchers; doctors and innovators; patients and loved ones have hoped for, and fought for, these past eight years: we will lift the ban on federal funding for promising embryonic stem cell research. We will vigorously support scientists who pursue this research. And we will aim for America to lead the world in the discoveries it one day may yield.

13 United States Under the auspices of the Obama administration, the NIH expands federal funding for stem cell lines that meet certain ethical requirements if: The embryo was discarded after IVF. Informed consent was obtained from the donors. The couple does not receive compensation (neither financial nor medical benefits) or are concerned or threatened.

14 United States Older stem cell lines created in the spirit the new regulations will be considered for federal funding, whereas embryos created solely for research purposes will be excluded.

15 NIH guidelines United States April 23, 2009: NIH published draft guidelines allowing funding for research on SCs derived from donated embryos leftover from fertility treatment, provided that certain conditions be met, such as the voluntary informed consent of donors. NIH continues to fund research on adult SCs and induced pluripotent SCs.

16 Australia Research involving SC is managed largely by the Australian Stem Cell Center (ASCC) based at Monach University in Melbourne. The ASCC has links with many universities around Australia and around the world. Bio21 at the University of Melbourne An Australian research base for Cygenics Ltd who, through their subsidiary Cordlife Pty Ltd, have moved some of their research from the USA to Australia.

17 Australia Therapeutic focus: Hematopoiesis Cardiac regeneration Respiratory diseases Therapeutic cloning is permitted. The main technology platforms used are: Embryonic SC (obtained from surplus IVF) Adult SCs Tissue repair and immune modulation

18 Funding Australia Australian SC Center who in-turn holds funding rounds. Source of funding: The Australian Government and the State Government of Victoria provide the majority of funding for the ASCC while a small amount comes from the commercial affiliations the ASCC maintain.

19 March 2005 Bill Brazil Authorizes the use of SC in research and therapy. It allows the use of SCs up to five days old that cannot be used further in IVF process Also allows unused embryos that have been frozen for at least 3 yrs.

20 Brazil The use of cloning techniques in order to obtain embryos is prohibited, whether the objective is therapeutic cloning or human cloning. Genetic engineering in embryos, eggs, and sperm is not allowed. The University of Sao Paulo has successfully tested the use of SCs as a treatment for diabetes.

21 Brazil Is still at an early stage regarding human SCs, but quite advanced in veterinary SCs, which are important models for research on humans. In order to carry out research with SCs, research groups must submit their projects to their institution's ethics committee as well as to CONEP (National Council for Ethics in Research).

22 Canada SC research is funded by a mix of the Canadian Institutes of Health Research The Canadian Stem Cell Network Genome Canada NSERC (the Natural Sciences & Engineering Research Council) National Cancer Institute Provincial governments US NIH

23 Canada ACT: Canadian Federal Government, March 2004 Banning human cloning for reproductive or therapeutic purposes. However, the Assisted Human Reproductive Act allows for Canadians to derive new human SC lines from embryos left over after fertility treatment. The agency was established in 2006.

24 Canada A Stem Cell Oversight Committee (SCOC) has been established by the Canadian research councils to conduct ethical review of all human pluripotent SC research proposals recommended for approval by their scientific peer review panels.

25 CARE-NET Canada Brings together researchers from four Canadian cities to study the use of adult SCs as repair material for damaged hearts, lungs and blood vessels. Canada has had a long history in SC research. Has currently more than 100 senior scientists working on SC.

26 China Growing interest in SC research (the government initiative). Chinese biotechnologies in general are now competing on innovation with their Western counterparts. Well-funded teams in China s major cities, some connected to large hospitals SCs from adult, fetal and embryonic sources.

27 China The country faces fewer moral or public objections to the use of embryonic SCs than Western nations. Production of new human embryonic SC lines are legal, as is therapeutic cloning. China s Ministry of Sciences & Technology (MoST) funds the bulk of the research directly.

28 China SC research in China is regulated by only one guideline, which was jointly issued by the Ministry of Science & Technology and the Ministry of Health in December Each local institution has a review committee of specialists of wide ranges. The committees are directly responsible for the authorization and surveillance of hesc research.

29 China SC research guidelines Prohibited: Reproductive cloning Transfer of an embryo into the uterus of a woman or animal Generation of chimeric human embryos However, there is regional lack of regulated stem cell procedure.

30 China Most of China s top university SC labs and centers have spun-off companies to commercialize their research. A typical example is SinoCells, a span-out from the Peking University s SC Research Center, which aims to develop cryopreservation methods for SCs. Potential for a cloning superpower Therapeutic cloning permitted.

31 France SC research strengths Developmental biology Pasture s announcement of establishing mechanisms by which ESCs differentiate to muscle cells. Neural SCs and cell therapies by the INSERM group for Huntington s disease, skin SCs, gene therapy The world s first gene therapy trail for children with immunodeficiency disorders (Hopital Necker).

32 France A Bioethics Act permits research on the embryo. Both therapeutic and reproductive cloning are banned under the Act. Licensing of embryo research will be the responsibility of Agence de Biomedicine. The Agency was established in May 2005.

33 France The French Academie des Sciences and Academie de Medicine both favor authorization of therapeutic cloning due to its potential in finding treatments for new diseases. There are growing signs of openness to discuss the issue and increasing political support for authorization of therapeutic cloning.

34 India Many Ms of $ are spent on SC research in India in the past years. The Department of Biotechnology under Ministry of Science & Technology is the nodal funding agency for supporting the SC R & D programs. Research is promoted for therapeutics applications using adult and embryonic SCs.

35 India Absence of laws specific to SC Research Government of India has drawn up a plan to effectively review and monitor the way stem cell research being conducted in the country. Institutions engaged in SC research (SCs to regenerate nerve, heart and adult muscle cells, and repair damaged bone tissue): L.V. Prasad Eye Institute, Chennai, Christian Medical College, Vellore, National Brain Research Center in Delhi.

36 Japan Allows scientists to conduct stem cell research for therapeutic purposes. No consensus on formal guidelines November 2007 Japanese researchers collaborated with American scientists reprogrammed human skin cells to behave like embryonic stem cells.

37 Japan In general, slow development of the regulatory framework. Continues to receive significant amount of public funding. Despite lack of a transparent regulatory framework, few human ESC lines have derived at Kyoto University using frozen embryos.

38 Japan On July 23, 2004, Japan s Council for Science and Technology Policy, the government top science and technology policy body, approved the final report of its Bioethics Expert Panel on human embryo and SC research. The report recommended a change in Japanese policy to allow the creation on human embryos using therapeutic cloning techniques for SC research.

39 United Kingdom In January 2001, Parliament agreed to regulations to allow research for therapeutic purposes on cells derived from human embryos. As part of the agreement, a House of Lords Select Committee on Stem Cell Research was formed to examine the issue in more detail.

40 United Kingdom Regulatory issues The rapid pace of advances in SC research has led to concerns that developments were moving too fast for the regulatory process to keep up! Among the key regulatory issues by the Lords SC Res Committee were the inadequacy of existing legislation & regulations and the possible need for further regulation to take recent developments into account.

41 United Kingdom The House of Lords SC Committee Weighted the ethical arguments carefully. While respecting the views of those who regarded any research involving the destruction of a human embryo wrong, it concluded that in light of the current law and social attitudes, it was not persuaded that all research on early human embryos should be prohibited.

42 United Kingdom The 14 Day Limit The Warnock Committee Chose a 14 day limit for research on human embryos because this is a the point at which the precursor to what will eventually develop into the nervous system becomes apparent. Although this is a somewhat arbitrary, the Lords SC Res Committee noted that it seemed to have been widely accepted in practice, and recommended that 14 days should remain the limit for research on early embryos.

43 United Kingdom UK is considered to be a world leader in its advancement of hesc research. Employs a more progressive approach and utilizes an extremely centralized, highly regulated system for human embryonic stem cell research.

44 Nascent programs Saudi Arabia Qatar Greater Middle East More established programs Iran Israel Turkey

45 Greater Middle East The Fiqh Council of the Muslim World League in Saudi Arabia it is permissible to obtain, grow and use SCs for therapeutic or permissible scientific research Islamic Republic of Iran Fatwa of 2002 encourages Iranian scientists to pursue SC research with the purpose of advancing technology to save lives.

46 CONCLISION Scientists and regulatory bodies in many countries are aware of the need for ethical evaluation and specific policies for SC research. Basic policy/bioethical issues: 1. Scientific and therapeutic relevance 2. Universal standards 3. Regulatory SC procedure

47 CONCLISION From a bioethical viewpoint, it is more questionable when dealing with embryos whose cryopreservation should be authorized by the parents which will be used either for a particular use or for donation. Currently, there is no global unanimity on SC research policies, standards and bioethical issues.

48 U.S. vs. U.K. CONCLISION The United States employs a decentralized system with little federal regulatory authority and broad discretion left to states and private entities. The United Kingdom utilizes a centralized, independent body, enabling it to act more quickly and periodically vis-à-vis SC research.

49 CONCLISION Finally, there are countries and regions that lack SC academics, specialists and policymakers to improve the quality of research as well as regulated SC procedure, however, international collaboration might solve the existing issues.

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