International Policies on Stem Cell Research

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.

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.

STEM CELL RESEARCH
                                                   Policies/
          Ethics
                                                  Regulations

                               Biology
 Related to the scientific                     To ensure patient
and therapeutic relevance                       accessibility to
      and integrity.                           products and gov.
                                              assistance for their
                              Preclinical    regulations & control.
                             safety issues

                             Therapeutic
                             application

International Policies on Stem Cell
              Research
• Ethics
   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.

International Stem Cell Research
• The average citation number for SC
  article
        United Kingdom                   15.30
        United Sates                     11.37
        Japan                            8.36
        Germany                          3.45

Source: Nature Reviews Molecular Cell Biol
10, 286 (April 2009)

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.”

United States
• May 24, 2005
     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.

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.

United States
• HR-2520, the “Stem Cell Therapeutic &
  Research Act of 2005” - 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.

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.

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.

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.

United States
• NIH guidelines
   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.

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.

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

Australia
• Funding
     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.

Brazil
• March 2005 Bill
     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.

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.

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).

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

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.

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.

Canada
• CARE-NET
     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.

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.

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.

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
  2003.
   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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.”

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.”

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.

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

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.

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

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.

CONCLISION
• U.S. vs. U.K.
   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.

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.