The International Society for Stem Cell Research Releases New Guidelines to Shape Future of Stem Cell Therapy
for Stem Cell Research (ISSCR), the world’s leading professional organization
of stem cell researchers, released new guidelines for the responsible
development of safe and effective stem cell therapies for patients. A
Commentary article that summarizes the Guidelines for the Clinical Translation
of Stem Cells will be published by Cell Press in the December issue of Cell
Stem Cell, the official affiliated journal of the ISSCR.
These guidelines define a roadmap for medical researchers and doctors,
outlining what needs to be accomplished to move stem cells from promising
research to proven treatments for patients. The new guidelines will
accelerate the translation of stem cell research into practice while
addressing associated scientific, clinical, regulatory, ethical and social
issues. Founded on core principles of scientific rigor and ethical conduct,
the recommendations offered in the guidelines include an insistence on expert
evaluation and independent oversight, a thorough informed consent process to
provide patients with essential information on the unique aspects of stem
cell-based treatments, and transparency in reporting of clinical trial
results.
“Our guidelines will arm patients and their doctors with the information
they need to make decisions about whether to seek stem cell treatments,” said
Dr.
guidelines and professor in clinical neurology at the University of
“Stem cell research holds tremendous promise for the development of novel
therapies for many serious diseases. However, as clinicians and scientists,
we recognize an urgent need to address the problem of unproven stem cell
treatments being marketed directly to patients.”
Too often rogue clinics around the world exploit patients’ hopes by
offering unproven stem cell therapies, typically for large sums of money and
without credible scientific rationale, oversight or patient protections.
This concern is further emphasized in a Correspondence article from Dr.
also appears in the December issue of Cell Stem Cell. A content analysis of
claims made on 19 Web sites offering so-called “stem cell therapies” was
performed to assess the portrayal of the services offered by each
organization. In addition, the authors assessed whether these claims are
substantiated by research reported in the professional medical literature.
The authors provide clear evidence that the vast majority of the clinics
examined over-promise results and gravely underestimate the potential risks of
their offered treatments.
The ISSCR’s new guidelines establish standards that can be used to judge
the claims made by stem cell clinics and whether the treatments they offer are
being developed responsibly. The ISSCR also offers a handbook for patients
and their doctors evaluating a stem cell therapy.
The ISSCR urges governments and regulatory bodies to enact the
recommendations outlined in these guidelines. The guidelines call for
countries without an official regulatory body to develop a way to monitor new
stem cell-based treatments, and the ISSCR has offered to advise agencies that
want to build these regulatory capacities.
“Regulators have a responsibility to prevent exploitation of patients in
their jurisdictions, and where necessary, to close fraudulent clinics and take
disciplinary action against the doctors involved,” said Dr.
immediate past-president of the ISSCR and associate director of the Stem Cell
Program at Children’s Hospital Boston.
To develop these new guidelines, the ISSCR convened an international task
force of experts in stem cell science, clinical research and bioethics from 13
countries. The task force was led by Dr. Lindvall and Dr.
member and associate professor of bioethics at the
University
“Our task force has captured the most current, comprehensive thinking on
translational stem cell research. The result — these new guidelines — will
be valuable for all members of the stem cell community,” said Dr.
president of the ISSCR.
Patients, medical researchers, regulators and those interested should
visit the ISSCR’s Web site at http://www.ISSCR.org to see the Guidelines, a
handbook for patients and more information on stem cell research. In
addition, the content of the Guidelines is digested in the Commentary article
authored by the task force, which is available online at
http://www.cellstemcell.com/.
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The International Society for Stem Cell Research (ISSCR) is an
independent, nonprofit membership organization established to promote and
foster the exchange and dissemination of information and ideas relating to
stem cells, to encourage the general field of research involving stem cells
and to promote professional and public education in all areas of stem cell
research and application.
Cell Press, an imprint of Elsevier, is committed to improving scientific
communication through the publication of exciting research and reviews. Each
of our titles is viewed as a must-read by the scientific community it serves.
Cell Press primary research journals include the flagship journal Cell, as
well as Neuron, Immunity, Molecular Cell, Developmental Cell, Cancer Cell,
Current Biology, Structure, Chemistry & Biology, Cell Metabolism, Cell Host &
Microbe, Cell Stem Cell and, new to Cell Press in 2008, The American Journal
of Human Genetics. Also new to Cell Press this year are the fourteen Trends
reviews journals, including Trends in Cognitive Sciences and Trends in
Neuroscience.
SOURCE International Society for Stem Cell Research