A committee of the International Society for Stem Cell Research (ISSCR) did one heck of a document dump yesterday on stem cell policy, releasing a whole bunch of policy recommendations on stem cells and more.
The torrent from ISSCR included a 37-page policy statement itself as well as several papers in top journals including the Lancet, Science, and Nature.
This output was the product of the members of a special ISSCR Task Force, whose members I have listed at the bottom of this post. Who are the members? These are knowledgable, extremely bright people who care deeply about the issues.
The stem cell policy positions of ISSCR and those in the associated publications were wide-ranging, touching upon everything from avoiding stem cell research hype to policies on human embryos to CRISPR of human embryos to three-person IVF/mitochondrial transfer, to clinical trials generally to patient-funded trials and more.
There’s a lot here and you can imagine for a stem cell policy wonk like me, it’s a bit like a kid in a candy store in terms of trying to figure out which thing to read first. On first glance, there’s a ton of good policy recommendations here. It will take a while to read through it all.
Stay tuned for more posts on this big policy development.
ISSCR Task Force (text taken from the policy statement)
STEERING COMMITTEE
Jonathan Kimmelman, Chair, STREAM Research Group, Biomedical Ethics Unit, McGill University, Montreal, QC, Canada
Nissim Benvenisty, Department of Genetics, The Azrieli Center for Stem Cells and Genetic Research, The Hebrew University of Jerusalem, Jerusalem, Israel
Timothy Caulfield, Health Law Institute, University of Alberta, Edmonton, AB, Canada
George Q. Daley, Division of Hematology/ Oncology, Boston Children’s Hospital and Dana Farber Cancer Institute, Boston, MA, USA
Helen E. Heslop, Center for Cell & Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital and Texas Children’s Hospital, Houston, TX, USA
Insoo Hyun, Department of Bioethics, Case Western Reserve University School of Medicine, Cleveland, OH, USA
Charles E. Murry, Departments of Pathology, Bioengineering and Medicine/Cardiology, Institute for Stem Cell and Regenerative Medicine, Center
for Cardiovascular Biology, University of Washington, Seattle, WA, USA
Douglas Sipp, RIKEN Center for Developmental Biology, Kobe, Japan and Keio University School of Medicine, Tokyo, Japan
Lorenz Studer, Center for Stem Cell Biology, Memorial Sloan Kettering Cancer Center, New York, NY, USA
Jeremy Sugarman, Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA
WORKING GROUP MEMBERS
Jane F. Apperley, Centre for Hematology, Imperial College, Hammersmith Hospital, London, UK
Roger A. Barker, John Van Geest Center for Brain Repair, Department of Clinical Neuroscience, Cambridge, UK
Annelien L. Bredenoord, Department of Medical Humanities, Julius Center, University Medical Center Utrecht, GA Utrecht, The Netherlands
Christopher Breuer, Center for Cardiovascular Research, Nationwide Children’s Hospital, Columbus, OH, USA
Marcelle I. Cedars, University of California San Francisco School of Medicine, San Francisco, CA, USA
Joyce Frey-Vasconcells, Frey-Vasconcells Consulting, Sykesville, MD, USA
Ying Jin, Institute of Health Science, Shanghai
Jiao Tong University School of Medicine/Shanghai Institutes of Biological Sciences, Chinese Academy of Sciences, Shanghai, P.R. China
Richard T. Lee, Department of Stem Cell and Regenerative Biology, Harvard University, Cambridge MA, USA
Christopher McCabe, Department of Emergency Medicine, University of Alberta, Edmonton, AB, Canada
Megan Munsie, Education, Ethics, Law & Community Awareness Unit, Stem Cells Australia, Department of Anatomy and Neuroscience, University of Melbourne, Parkville, Victoria, Australia
Steven Piantadosi, Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, CA, USA
Mahendra Rao, The New York Stem Cell Foundation Research Institute, New York, NY, USA and Q Therapeutics, Salt Lake City, UT, USA
Masayo Takahashi, Center for Developmental Biology, RIKEN, Kobe, Hyogo, Japan
Mark Zimmerman, ViaCyte, San Diego, CA, USA
SUPPORTED BY ISSCR STAFF:
Heather Rooke, Scientific Director
Glori Rosenson, Director of Outreach
@Gregor – Yes, we are much better off when government bureaucracies and big companies collude to do it.
@ Bill Jones – I guess that goes to show how important it is to make sure that key policy decisions are not left to scientists alone.
I guess I should put there here as well.
There is a widening gap between academic and commercial enterprises in regards to the clinical trial process, said Arnold Caplan, PhD, from Case Western University, who coined the term mesenchymal stem cell in 1991 and is considered a founder of the field. “The whole value system of running a clinical trial and being judged against standard of care, which is a pharmacological concept, is completely illogical.”
…but what does he know?
http://hsci.harvard.edu/msc-colloquium
They are clearly backing up the FDA stance here on the use of autologous SVF:
When a cell-based product is claimed minimally manipulated and exempt from regulatory oversight on this basis, the onus rests on the practitioner to
invite scrutiny over their process of cell manipulation, such that independent, disinterested experts can determine the proper level of regulatory oversight. Recent draft guidance provided by the FDA for public comment represents a thoughtful and cogent set of principles to delineate when manipulation of
autologous cell-based products can no longer be considered minimal or their use homologous, and must therefore be subject to FDA oversight (Food and Drug Administration, 2014).