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2001
Stem Cells: Opportunities and Challenges
Prepared For
Canadian Biotechnology Advisory Committee Advisory Memorandum
January 15, 2001
Table of Contents
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Background
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Recent Policy Developments
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CBAC and Stem Cells
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Recommendations
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Background
The term "stem cells" refers to cells found in animal
and human tissues that are non-specific or
"undifferentiated" but are capable of developing into
"differentiated" cell types with specific structural
and functional characteristics (e.g., bone cells, muscle cells,
nerve cells). While the undifferentiated cells of the early
embryo are the most commonly recognized examples of stem cells,
such cells also exist in adult tissues and some differentiated
adult cells can be made to behave like stem cells.1
Two major recent advances in stem cell biology have generated
both excitement and concern. They are the demonstration that
"pluripotent" stem cells can be successfully isolated
and cultured from embryonic or fetal tissue and, the reports
that stem cells from adult tissues have the potential to develop
into cells with a wider variety of specific characteristics than
previously believed. Both of these discoveries may lead to a
variety of clinical applications. These may include tissue
replacement therapies where none have been available in the past
and more effective approaches where existing methods are of
limited use because of complications such as tissue rejection.
The public policy implications of these advances are more
salient in the case of primordial stem cells than adult stem
cells because of the source of primordial stem cells and
explicit or implicit prohibitions on research involving human
embryos and fetal tissue now in existence in many countries. The
overarching question is whether these advances should lead to a
reconsideration of current prohibitions and, in particular,
whether new policies and guidelines are needed pertaining to
research on primordial stem cells.2 The answer to this question may
well vary amongst different jurisdictions depending on current
policies and practices.
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Recent Policy Developments
In light of the impressive potential of stem cell research and
its ethical implications, expert groups in the United States
(USA) and the United Kingdom (UK) have examined this issue and
produced reports to guide policy development. Both groups
recommended, subject to conditions that reflect the differences
in the social and ethical considerations applicable to the
various ways in which stem cells are derived, that stem cell
research not be prohibited. However, the specific policy
initiatives resulting from these reports differ significantly as
between the USA and the UK. These initiatives and those in other
jurisdictions are described in a paper, prepared for CBAC by Ms.
Lori Knowles of the Hastings Center, appended to this
Memorandum.3
In Canada, the recommendations on assisted reproductive
technology (ART) contained in the Report of the Royal Commission
on New Reproductive Technologies (1993) may be interpreted as
being relevant to stem cell research. However neither those
recommendations, nor the voluntary moratorium on certain
reproductive technologies called for by the Minister of Health
in 1995, have legal regulatory force. Bill C-47 (the Human
Reproductive and Genetic Technologies Act), which died on the
Order Paper in April 1997, included provisions related to embryo
research. However, the bill antedated recent discoveries related
to stem cells - as did the Tri-Council Policy Statement:
Ethical Conduct for Research Involving Humans published in
1998 and the question remains as to whether current Canadian
guidelines on embryo research and fetal research require
revision or amplification in the light of recent scientific
developments.
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CBAC and Stem Cells
CBAC's program plan includes a special project on Novel
Genetically-Based Interventions. This project includes
topics such as human cloning, stem cells, xenotransplantation
and gene therapy. Given the speed of new developments, the
potential therapeutic benefits that may flow from them and the
profound ethical issues to which certain applications of stem
cell research give rise, CBAC is in the process of advancing
some of its planned work in this important area. This may
include studies of the ethical, legal and developmental aspects
of stem cell research in the context of the situation in other
jurisdictions but with special emphasis on the legal, regulatory
and political circumstances of Canada.
CBAC has members with special interest and expertise in certain
key aspects of stem cell research and its potential
applications. These members also have connections with other
groups undertaking or contemplating work in this area, thereby
enhancing the potential for productive collaboration. In
addition, CBAC will be involving other experts either to
undertake specific studies or to join CBAC's Project
Steering Committee. To begin this process, CBAC commissioned Ms.
Lori P. Knowles, Director, Research and Outreach of the Hastings
Center, to prepare an analysis of evolving policies, in various
jurisdictions, on the derivation and use of stem cells.4
One of CBAC's most important roles, and a key element of its
mandate, is to provide a forum for Canadians to become informed
about and engage in discussion of important developments in
biotechnology such as those represented by advances related to
stem cells. In fulfilling this role, CBAC will synthesize the
outcome of its own studies and deliberations with those of other
groups in order to provide Canadians with a comprehensive view
of the context for public policy development.
The Canadian Institutes of Health Research has established a
working group on stem cell research and it may well be that
other groups will be taking up this issue. For this reason it is
desirable that interested parties be alerted to the work that
CBAC has planned in this area so that appropriate information
exchange and liaison mechanisms might be developed to avoid
undesirable duplication of effort and to promote effective use
of limited resources - including the relatively small pool of
Canadian experts.
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Recommendations
In the light of the foregoing, CBAC recommends that:
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BMCC take note of recent discoveries pertaining to stem
cells and the international trends in policy development
arising from them;
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Canada establish a broad framework of regulation
pertaining to ARTs, including embryo research, that
addresses the scientific, ethical and social issues raised
by primordial stem cell research and that it is readily
adaptable to new discoveries and to experience gained in
the application of the new technologies; and,
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As an interim step, current guidelines pertaining to
research involving embryos and fetuses be reviewed and
revised as necessary or desirable to take account of
recent and projected scientific and technological advances
related to primordial stem cells.
CBAC looks forward to participating in the processes that
are involved in the implementation of either or both of
the latter two recommendations.
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1 Sources of stem cells: early
embryos created by in vitro fertilization; early
embryos created by cell nuclear replacement (inserting the
nucleus of an adult cell into an egg from which the nucleus has
been removed); from the germ cells or organs of an aborted
fetus; from umbilical cord blood; from some adult tissues such
as bone marrow or skin; from mature adult cells programmed to
behave like stem cells.
Adapted from the report of Chief Medical Officer, United
Kingdom: Stem Cell Research: Medical Progress with
Responsibility. June 2000.
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2 The term primordial stem cell is used to denote the
stem cells present in human embryos (ES) and the germ cells present
in the fetus (EG)
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3 L.P. Knowles, Comparative Primordial Stem Cell
Regulation: Canadian Policy Options. Canadian Biotechnology
Advisory Committee, December 2000.
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4 ibid
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