Registration of Stem Cell Based Clinical Trials

WORLD STEMCELL REPORT 2009 GENETICS POLICY INSTITUTE 501c3
2010 WORLD STEMCELL SUMMIT DETROIT, MI OCTOBER 4-6, 2010 WWW.WORLDSTEMCELLSUMMIT.COM WWW.GENPOL.ORG
15
STEM CELLS, REGENERATIVE MEDICINE, AND SOCIETY
ubstantial progress in stem cell research has
been made since the first report on the
derivation of human embryonic stem (ES)
cells.
1
As we celebrate the 10th anniversary of this
landmark event, we also witness new scientific
2
and policy
3, 4
milestones that reinvigorate hopes
for moving forward the clinical translation of stem
cell-based interventions. Nevertheless, stem cell-
based therapies remain largely at the
experimental stages and the road towards the
clinical is still paved with major scientific
5, 6
and
ethical
7
hurdles. A positive signpost though, is the
recent approval of what will be the worlds first
clinical trial of a hESC-derived product by the
United States Food and Drug Administration
(FDA).
8
Geron Corporation has been granted
clearance for an Investigational New Drug (IND)
application for the clinical trial of GRNOPC1 in
patients with acute spinal cord injury.
This article briefly addresses the rationale for establishing clinical
trial registries (CTR) and the challenges arising from their
implementation. A Clinical Trial Registry (CTR) is a publicly
available database of all human interventional clinical trials*
regardless of the stage of development at inception, while in
progress or after completion and of their publication status. The
raison dtre for mandating the prospective registration of all stem-
cell based clinical trials will be discussed. It is beyond the scope of this
paper to provide a comprehensive analysis of the wide range of
possible approaches, policy responses and their implications.
However, we want to provide a starting point for discussion
surrounding key questions and challenges facing clinical trial
registration, questions that go beyond a call for voluntary
publication.
S
Moving Towards the Clinic: Science,
Policy and Ethics
Alongside these new scientific advances, important policy
developments have also taken place. The International Society for
Stem Cell Research (ISSCR) adopted the first professional guidelines
setting standards for the clinical translation of stem cells
9
in three
major areas: cell processing and manufacturing, pre-clinical studies
and clinical research. The guidelines encompass recommendations
and establish principles for the scientific, clinical and ethical conduct
of translational stem cell researchers, clinician-scientists, and
regulators in the international community.
In the context of medical research ethics in general, another
significant policy development took place while we celebrate a decade
since James Thomsons discovery. The World Medical Association
amended the Helsinki Declaration,
10
the primary source and arbiter
of research ethics worldwide.
11
While the Declaration is addressed
primarily to physicians, the WMA intends for the Declarations scope
to reach a full range of stakeholders.
Both the Helsinki Declaration and the ISSCR guidelines
recognize that authors, editors and publishers have ethical obligations
with regard to the full publication of research results, whether
negative, inconclusive or positive. Similarly, they recognize the right
of research participants in particular and society in general to have
access to this information. Moreover, the Declaration of Helsinki
took the unprecedented move to call for the registration of every
clinical trial in a publicly accessible database before the recruitment of
the first research subject (Principle 19). In contrast, the ISSCR
guidelines called only for the publication of both positive and
negative results and adverse events at professional scientific
conferences or in peer-review scientific journals before reporting their
research to the lay media or to patient advocacy groups and
associations (Recommendation 33).
The aforementioned policy recommendations are of significant
importance as they establish principles for strengthening transparency
in clinical research by calling for the prospective publication of
research results. By promoting transparency, they are encouraging
scientific and ethical integrity in clinical trials. They are also seeking
Registration of Stem Cell-Based
Clinical Trials: A Scientific and
Ethical Imperative
By Rosario M. Isasi, J.D., M.P.H.
*
The World Health Organization defines, for the purposes of registration, a clinical trial as any research study that prospectively assigns human participants or groups of humans
to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are
not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.
This definition includes Phase I to Phase IV trials. http://www.who.int/ictrp/en/
16
trial results.
23
It sought transparency and accountability in scientific
research with human participants.
When proposing human clinical trials, ethics demands
evidence.
24
Clinical trial registration aims to meet this ethical duty by
facilitating access to the details of both clinical trials protocol and its
initiation (e.g. objectives, main design features, sample size, and
tested treatments) and to results of key trial endpoints,
25
in a
comprehensive and objective manner. As stated in the introduction,
a Clinical Trial Registry (CTR) is a publicly available database of all
human interventional clinical trials regardless of the stage of
development and of their publication status.
In order to be effective, clinical trial registries must be global,
comprehensive, accurate, and publicly accessible. In addition, access
to a registry should be simple, inexpensive and appropriate to the
intended user population to allow for the unrestricted dissemination
of research results. All these should be coupled with an independent
verification of postings and compliance mechanisms in order to
ensure that ethical standards in clinical practice are respected.
The raison dtre for the establishment of a CTR is to serve as a
vehicle for knowledge transfer by providing an unbiased public record
on safety and effectiveness, which in turn is translated in the
foundation of evidence-based medicine. Moreover, by requiring the
prospective registration of clinical trials at their inception, the
problem of bias in the body of evidence could be largely eliminated,
as registration in a CTR would occur independently of the ultimate
findings or publication status of a trial. (Table 1)
to maintain public trust, essential for the feasibility of any scientific
endeavor but even more so in an area that has elucidated so much
political, social and ethical controversy, that of stem cell research.
Over the past decades, clinical trials of stem cell-based
interventions (e.g. transplantation) have been carried out using
umbilical cord blood stem cells and autologous adult stem cells (e.g.
hematopoietic stem cells or blood stem cells) to treat diseases such as
leukemia, lymphoma and several inherited blood disorders. The
safety and efficacy of these interventions has been well established.
Conversely, interventions using human embryonic stem cells and
fetal tissue are still in early experimental stages. Controversial clinical
trials using these same sources of stem cell lines are reportedly being
conducted in several countries,
12
some with little scientific or other
oversight and no evaluation of clinical outcomes and safety.
Indeed, unproven stem cell interventions outside a clearly
regulated clinical trial are proliferating around the world, facilitated
by loopholes in several national regulatory systems or even
encouraged by government support.
13
Confusion between these
unproven interventions and scientifically sound and rigorously
designed clinical trials puts at risk not only the safety of research
participants, but also damages the integrity of the field as it erodes
public trust.
14
Similar negative effects arise from the lack of
transparency in disclosing the protocol design and its outcomes in a
number of legitimate stem cell-based clinical trials and interventions.
In the field of stem cell research, the prospect of clinical trial
registration has seldom been explored. This is inspite of a global
consensus
15
that recognizes the need for prospective registration of all
interventional trials as a scientific, ethical and professional imperative
(if not a legal obligation) for scientists, governments and funding
organizations.
16
This duty is grounded in the fundamental need to
disseminate knowledge and protect and respect research participants
and patients.
17
Notwithstanding this consensual duty, a gap between
the number of trials conducted and the number for which results are
publicly available persists and has been well-documented.
18
To address
this problem, a wide variety of stakeholders have adopted a broad
range of approaches.
19, 20
They range from policies mandating clinical
trial registration as a pre-condition of publication,
21
to the creation of
national registries* and an International Clinical Trial Registry
Platform by the World Health Organization (WHO).**
Clinical Trial Registration and Its
Raison dtre
The movement towards establishing clinical trials registration
emerged as a reaction to scandals surrounding structural flaws in the
clinical trials enterprise
22
that ranged from publication bias,
regulatory lapses, to secrecy and intentional misrepresentations of
*
See for example the following national clinical trial registries: USA Clinical Trials.gov, Australian New Zealand Clinical Trials Registry (ANZCTR), Chinese Clinical Trial Register
(ChiCTR), Clinical Trials Registry India (CTRI), German Clinical Trials Register (DRKS), Iranian Registry of Clinical Trials (IRCT), Japan Primary Registries Network, The
Netherlands National, Trial Register (NTR), Sri Lanka Clinical Trials Registry (SLCTR)
**
The WHO International Clinical Trials Registry Platform (ICTRP) overall objective is to ensure that a complete view of research is accessible to all those involved in health care
decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base. The ICTRP was developed in
collaboration with the International Standard Randomised Controlled Trial Number (ISRCTN) register, based in the UK, and the ClinicalTrials.gov registry, based in the US, the
ICTRP with the aim to promote consensus regarding international norms and standards in clinical trial registration. The ICTRP requires that clinical trials are registered at inception
and proposes that a unique Universal Trial Reference Number be given to each trial to prevent duplication. The ICTRP is not a registry itself but a comprehensive search portal for
registries that exist worldwide. http://www.who.int/ictrp/en/
Table 1: Clinical Trial Registry: Objectives
1. Respect the investigator-participant covenant
to contribute to biomedical knowledge by
making trial methods and findings public.
2. Strengthen protection and respect for research
participants
3. Foster accountability and transparency with
regard to global standards for ethical research.
4. Provide a foundation for evidence-based
medicine
5. Serve as a vehicle for knowledge transfer by
providing an unbiased public record on safety
and effectiveness
6. Advance innovation and acceleration of
research practice in clinical therapies
17
Transplantation of cells derived from pluripotent stem cells is
still a highly innovative practice and consequently, a great degree of
uncertainty exists with respect of weighing the benefit/risk ratio for
such interventions. The advantages that pluripotent stem cells possess
in terms of their capacity for self-renewal and differentiation; are
paired with the immense challenge of establishing mechanisms to
adequately control them in order to prevent negative effects such as
Furthermore, it is the goal of a CTR to enable to carry out meta-
analyses. Meta-analyses or quantitative overviews are the primary
means by which the safety and efficacy of new drugs and other
interventions are assessed. Often individual clinical trials lack
adequate statistical power to reliably adjudicate between alternative
treatments strategies. It is therefore necessary in many instances to
conduct meta-analyses or quantitative overviews of all relevant trials
in order to draw conclusions about the efficacy of a particular
treatment or procedure.
26
To this date, the results of meta-analysis
studies have improved clinical practice in many areas of medicine.
27
Stem cell research plays a key role in the increasingly promising
area of regenerative medicine, showing potential to improve our
ability to treat, prevent and cure disease by providing a potential
unlimited source of cells for organ transplantation and therapies.
Stem cell research could also provide a successful model system for
drug discovery, including the development of new testing methods
for efficacy, toxicity and safety. It will improve our understanding of
the processes of human cell differentiation and development, with
possible positive consequences for the treatment of diseases such as
cancer. Finally, research using induced pluripotent cell (IPs cells) and
somatic cell nuclear transfer (SCNT) will create patient-and-disease
specific stem cell lines for research purposes and eventually, for safe
and effective therapies.
28
Table 2
The registration of all interventional trials is a
scientific, ethical and moral responsibility. WHO
International Clinical Trials Registry Platform (ICTRP)
A Snap-shot of Stem Cell-based Clinical Trial
available through WHOs ICTRP*
Key Word Number of Trials
Stem Cells 1837
Hematopoietic Stem Cells 470
Autologous Stem Cells 19
Cord Blood Stem Cells 03
Embryonic Stem Cells 03
Adult Stem Cells 18
Fetal Stem Cells 0
IPs 03
*The search was conducted on June 15th 2009.
http://www.who.int/ictrp/en/
tumor formation, excess proliferation, inappropriate differentiation,
improper localization, among other serious adverse events. The
potential for significant risks arising from these interventions are
distinct from all other therapies. Accordingly, they warrant particular
scrutiny with regards to their protocol design, conduct and analysis
(e.g. type of cell, disease or condition concerned, control cases,
participant enrollment, ethics approval, outcomes, follow-up, etc.); to
say nothing about evidence of safety and efficacy.
29
On this latter
point, the recommendations issued in ISSCR`s Clinical Translation
guidelines are illustrative. The guidelines call on researchers to
publish positive results, negative results, and adverse events and thus
promote transparency, to prevent others from being subjected to
unnecessary risk in future clinical research and to ensure the
development of clinically effective and competitive stem-cell based
therapies.
30
The impact of trial registration of cell-based clinical
interventions should not be taken lightly. The continuous and
comprehensive registration of these interventions could significantly
impact the foundation of evidence-based medicine, and even shape
clinical practice by supporting the translation of research from the
bench to the bedside through the development of best practice
guidelines. To draft best practice guidelines such as those adopted
by ISSCR -, professional organizations rely on the body of scientific
evidence; which in turn outlines the current standard of care.
Similarly, policy-makers often rely on such evidence when drafting
laws and regulations dealing with scientific and medical practice. As
a result, clinical trial registration could have a great impact in shaping
not only public policy, but also medical or product liability. The latter
is of particular importance given the already mentioned proliferation
of scientifically unproven and ethically problematic cell-based
interventions.
The principle of benefit sharing provides an additional
justification for advocating for the prospective registration of clinical
trials. Clinical trials contribute to building societys collective
knowledge. The financial investments committed by sponsors of
clinical research especially when obtained by public funders
demand for the resulting knowledge to be shared.
31
by informing
priority setting and the planning of future studies, identifying trends
and gaps and avoiding unnecessary duplication (which must be
distinguished from appropriate replication) of research.
Of equal importance are the objectives of respecting the
investigator-participant covenant to contribute to biomedical
knowledge by making trial methods and outcomes public. Most
often, the participation of healthy volunteers in a clinical trial takes
place because such individuals believe they are contributing to the
generation of medical knowledge. However, when the knowledge
gained is never transferred, the trust between investigators, research
participants and the public at large is breached.
Fostering accountability and transparency with regard to global
standards for ethical research is also a goal of clinical trial registration.
A fundamental tenet of research ethics is respect for autonomy. For
research participants to be respected as autonomous agents, they must
provide free, voluntary and informed consent. The latter can only be
achieved by publicly disclosing the body of evidence as pertains to
trial findings (inconclusive, negative or positive), thus making explicit
18
the current standard of care .This public record empowers research
participants, enabling them to make informed decisions, especially
with respect to the balancing of the benefits and risks of participation.
It further mitigates the chances of therapeutic misconception.
Strengthening protections for research participants in early stem cell-
based clinical trials is necessary given the highly innovative nature of
these interventions, and the likelihood that recruitment of research
participants would be done from the most vulnerable populations
(e.g. the severely ill).
32
Clinical Trial Registration: Challenges
At the present time, registration of clinical trials is generally
voluntary, making compliance mechanisms difficult to enforce.
However, some national jurisdictions and international institutions
policies have adopted policies making registration a compulsory
requirement (e.g. USA, India, Australia, Argentina, European
Commission, etc.). Unlike the World Health Organizations Clinical
Trial Platform, which is based on voluntary registration, the
International Committee of Medical Journal Editors (ICMJE)
33
mandates that any manuscript detailing clinical trial findings must be
recorded in a publicly accessed registry before it can be published.
The ICMJE, an organization which represents eleven renowned
medical journals, has thus taken the initiative to prevent publication
bias while giving researchers an incentive to register their trials.
In the stem cell research context, as previously stated, the ISSCR
stopped short of calling for mandatory clinical trial registration of all
stem cell-based clinical trials. It opted instead for calling for the
publication of research findings via scientific conferences and peer-
reviewed journals, thus confining to a certain extent* the
dissemination of knowledge to professional circles. The timely
publication of research findings is particularly important in a rapidly
evolving field that has elicited so much hope, hype and polarized
political, social and ethical debates. Dissemination of research
findings in scientific circles (e.g. conference, journals) and trial
registration should not be interpreted as excluding requirements but
rather as having a complementary role. A clinical trial registry if
adequately designed targets not only the scientific audience but also
to the lay public, thus making information available to a wider
audience.
The success of a clinical trial registry relies on its ability to meet
the needs of the primary intended users, patients and other members
of the public. But ultimately it depends on a willingness to contribute
to a joint enterprise for the common good.
34
In order to ensure
compliance, institutional review boards should require clinical trial
registration as a condition of approval
35
and so institutional
responsibility would be established.
Aside from implementing compliance mechanisms, the
auditing, monitoring and oversight of existing registries are additional
difficulties that must be overcome in order for clinical trial
registration to be effective. Similarly, to maintain trust, safeguards to
protect privacy and confidentiality of research participants and
proprietary information should be established. A registry includes
extensive data coming from multiple sources; it requires frequent
updating to remain thorough and correct. Therefore, verification
procedures must be enforced to ensure accuracy and quality
assurance.
It is argued that clinical trials should be registered at all phases,
even at inception, in order to ensure full disclosure. Without the
registration of clinical trials at all phases, it would be impossible either
to know adverse reactions or to assess safety and efficacy. The
registration of early-phase clinical trials would ensure then that the
risks related to new interventions or treatments are publicly known,
36
thus preventing ineffective or harmful interventions from continuing.
If clinical trials are registered only after they have been completed and
found to be favourable, or published, publication bias will result.
Furthermore, requiring that clinical trials be registered at inception
would prevent the loss of potentially valuable scientific information
due to early trials that are often terminated for economic reasons.
37
Particular challenges relate to the design and scope of a clinical
trial registry for stem cell lines, especially concerning the
establishment of a minimum data set as it would require agreement
on standard data elements. A mandatory, minimum data set fosters
transparency and accountability by providing a comprehensive and
transparent (non-promotional) posting of methodology and results.
The currency and accuracy of the information in a prospective
registry is of paramount importance. In the case of stem cell clinical
trials, data must include information regarding the origin of the
human stem cell lines, their derivation and culture methods and
conditions, traceability requirements as well as their banking
procedures.
Clinical trial registration still faces unyielding resistance from the
pharmaceutical and biomedical industries. As these industries
account for the majority of clinical trials sponsors, it is essential that
these industries participate and comply with registration and
publication standards. Their reluctance steams on the alleged adverse
effects of trial registration on their intellectual property rights,
commercial or academic competitive advantage; as well as on the
dangers of international piracy and/or the disclosure of trade secrets.
38
All of these factors could negatively target their therapeutic
development and regulatory strategies, potentially damaging investor
interests and stock value.
39
The pharmaceutical and biotechnological industries concede
that the dissemination of knowledge and the protection of the rights
and the safety of patients (and research participants) should triumph
over concerns for the confidentiality of proprietary interests, the
protection of academic freedom and the exclusivity of research ideas.
40
However, they argue that clinical trial registration would not have the
effect of increasing safety or protections for research
participants/patients nor of diminishing publication bias. It remains
to be seen if a balance between those conflicting interests could be
achieved in order to serve the public interest. As pointed out by
Rennie, the financial cost of an effective, independent and
transparent clinical trial register would amount to a tiny fraction of
the costs of the trials themselves, or the costs of not knowing their
*
ISSCR published along to the Guidelines for the Clinical Translation of Stem Cell, a Patient Handbook on Stem Cell Therapies (December 2008), providing valuable scientific
information for patients and their doctors evaluating a stem cell therapy.
19
results, while the personal costs of allowing the present chaotic system
to continue are incalculable.
41
Conclusion
History has taught us many cautionary lessons of significant
harms arising from moving forward with a scientific field of inquiry
without transparency and accountability. These harms go beyond
physical harms to research participants, but they extend to ethical and
moral ones that reach society and science itself, eroding public trust.
Scientific research holds out much promise for potential social
benefits for funders, research participants and society in general.
However, this promise cannot be realized if research findings are
concealed, selectively reported or misrepresented. The global
consensus declaring the prospective registration of clinical trials a
scientific, ethical and professional obligation is a major milestone.
Yet, this recognition is insufficient in the absence of compliance. To
date, voluntary schemes calling for publication and registration have
met with limited success.
Prospective disclosure of research findings and clinical trial
results fosters innovation and scientific rigor. As stem cell research
rapidly evolves, bringing us one step closer to the clinic, the time is
ripe to remind us all of the ethical duties we owe to society, to science
and to ourselves. Hence, this renewed call for making clinical trial
registration a mandatory requirement.
Acknowledgements
The author thanks the Canadian Stem Cell Network and the
International Stem Cell Forum for their funding support. The author is
especially grateful to Maya Shukairy for providing expert research
assistance and valuable comments. The opinions are those of the author
alone.
Rosario Isasi is currently a Researcher the
Centre of Genomics and Policy, Faculty of
Medicine, Department of Human
Genetics, Mc Gill University.
Her research interests intersect public
health, ethics, law and science. She has
particular expertise in the area of
comparative law and international governance issues surrounding
regenerative medicine and stem cell research. She has published in
Science, Human Reproduction, Cell Stem Cell, Stem Cell Research,
AJLM, JLME among other journals.
Closely related to her academic work is her role as a policy adviser to
government, professional and international bodies, such as the
United Nations, where she played an active role in the adoption of
the UN Declaration on Human Cloning. Most recently, she has
contributed to the Bioethics Education Project of the Royal College
of Physicians and Surgeons of Canada.
Rosario Isasi is the Academic Secretary of the International Stem
Cell Forum Ethics Working Party and a member of the Hinxton
Group, an international Consortium on Stem Cells, Ethics and
Law. She is also a member of the Legal and Human Rights Advisory
Board of the Genetics Policy Institute; and member of the advisory
board of Global Lawyers and Physicians, a transnational
professional association of lawyers and physicians working together
to promote human rights and health.
She holds her J.D. from the Pontifical Catholic University of Peru,
where she practiced corporate and health law. She received her
Masters of Public Health from Boston University, USA.
Rosario M. Isasi, J.D., M.P.H.
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22
n March 9, 2009 President Barack Obama
signed an Executive Order expanding
federal funding for research using
embryonic stem cells in a White House signing
ceremony packed with legislators, scientists, and
people who have suffered from a range of
diseases and medical conditions that could
benefit from the research. The Presidents
executive order was a major milestone in the 10-
year effort by those patients, scientists,
academics, and others who have argued in
support of a broader federal stem cell policy.
1
In some ways, the most telling aspect of the ceremony was that
when President Obama signed the Executive Order, numerous
members of Congress were in attendance. Their presence signaled a
significant shift in public opinion regarding the use of federal funding
for embryonic stem cell research; further, it demonstrated the
attitudinal changes regarding stem cell science that have taken place
since 1998, when embryonic stem cells were first derived.
Today, for many Americans, stem cell science is viewed as
potentially beneficial not just for people suffering from disease
but in maintaining the countrys prominence and preeminence in
scientific leadership. In a remarkably short timeframe, stem cell
science has made the unusual transformation from a non-issue to a
political hot button and to an issue that transcends politics.
Background
Embryonic stem cells were first discovered in 1998 by Dr. Jamie
Thomson of the University of Wisconsin and Dr. John Gearhart of
the Johns Hopkins University.
2, 3
While widely applauded for its
potential in the scientific community, their discoveries very quickly
set off a firestorm affecting researchers, ethicists, politicians and, most
importantly, patients in the United States (US) and around the
world. In fact, the first series of congressional hearings on the science
followed quickly, beginning in January 1999, when the Senate
Committee on Health, Education, Labor, and Pensions convened
sessions involving a series of top researchers and ethicists.
4
What became clear at the outset was that most US policymakers
did not have an understanding of stem cell research and therefore
were uncomfortable with the concept. Almost immediately, the
source of embryonic stem cells became a key issue in the discussion
and debate and initially there were broad misunderstandings about
the origin of stem cells with many assuming the issue to be
O
associated with abortion.
At the time, relatively few legislators had a clear understanding
of the reality; the stem cells at the center of the issue were cells derived
from embryos created for in vitro fertilization (IVF) procedures. In
fact, the cells in question were not going to be used and were slated
to be discarded.
More often than not, the creation of embryonic stem cells was
erroneously linked to abortion, and the corresponding political,
moral, and religious issues that it entailed. To compound the
problem, there were a handful of legislators and others that might
have understood that abortion was not tied to stem cells, but did not
have a detailed understanding of or were uncomfortable with the IVF
process itself. As a result, the immediate political reaction to the 1998
Thomson/Gearhart discoveries leaned toward a ban on the research.
The Role of Patient Advocacy
In response to initial fears and negative reactions (often based on
misunderstanding), an organized effort was launched on the part of
patient advocacy groups to delay any potential federal ban on
embryonic stem cell research. The aim was to provide education on
the role of stem cells, the science, and their potential for therapies and
cures for leading conditions. In addition, time was needed to enable
discussion and debate related to surrounding ethical and religious
implications. This effort started with Patients Cure, originally formed
by Dan Perry, who was the Executive Director of the Alliance for
Aging Research. Patients Cures major focus was to slow the
momentum of any amendments that might surface in Congress
restricting federal funding and support for stem cell research.
Patient advocacy in the area of stem cell research emerged among
the campaign promises made by then Presidential candidate George
W. Bush, who pledged to impose a ban on federal funding for
embryonic stem cell research. Once elected, it was clear that a larger
scale and more comprehensive effort would be required to preserve
federal funding for the research if not the ability to conduct stem
cell research itself.
Formation of the Coalition for the
Advancement of Medical Research (CAMR)
The result was the creation of the Coalition for the
Advancement of Medical Research (CAMR). Today, CAMR
comprises more than 100 nationally recognized patient organizations,
universities, scientific societies, and foundations, and conducts
advocacy and education outreach focused on developing better
treatments and cures for people with life-threatening illnesses and
disorders.
Federal Funding of Stem Cell
Research: Past, Present and Future
By Lawrence A. Soler, J.D.

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WORLD STEMCELL REPORT 2009 GENETICS POLICY INSTITUTE 501c3

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