World Congress

for freedom of scientific research

New ISSCR's President on stem cell research and therapies

01/20/2010

The new President of the International Society for Stem Cell Research - ISSCR, Irving Weissman, addresses research on all forms of stem cells, including reprogramming and the "sad practice of unapproved stem cell therapies". (published on "The ISSCR: Who Are We and Where Are We Going?", Irving Weissman, 7 August 2009, Cell Stem Cell 5(2) pp. 151 - 153 "The ISSCR - he says - has consistently endorsed research on all forms of stem cells, including pluripotent stem cell lines derived via IVF, NT, parthenogenesis, or gene-based reprogramming. The ISSCR supports such stem cell research globally, where performed under rigorous standards of research ethics described in the 2006 ISSCR Guidelines for the Conduct of Human Embryonic Stem Cell Research". "In the final NIH guidelines, - he continues - the bans remain on funding research using already established parthenogenic and NT pluripotent stem cell lines, however ethically obtained and however faithfully they replicate the pathogenesis of the human diseases from the patient nucleus donor. They do not cite a scientific reason for the ban. I will ask approval of the executive committee, and the society, to continue to call for a reversal of bans on funding research on established, ethically developed human NT and parthenogenic pluripotent stem cell lines". As far as it concerns stem cell therapies, Weissman points out that: "There is no scientific basis for such transdifferentiation to date and no approved therapies using ESCs. If an enquirer is in the biomedical field, I remind him/her that there is now a pretty good operational way to determine whether a phenomenon, such as transdifferentiation, is real: (1) The scientific basis (e.g., of transdifferentiation) must be published in a peer-reviewed journal, but that is not enough. (2) Several independent laboratories should have confirmed and published in peer-reviewed journals that the findings as first published are reproducible, but that is not enough. (3) The principle that underlies the discovery (e.g., transdifferentiation) is so robust that any way you approach the issue, the discovery is validated, but that is not enough when therapeutic cell therapies are the objective. (4) The regeneration of tissues is rapid, robust, tissue-appropriate, and curative, not simply rare cells of uncertain origin. But these are not issues the lay public calling for the cures promised can judge alone. My own advice is that they should attempt to obtain the following from the stem cell companies or clinics before they agree to a therapy: (1) The provider must be able to send peer-reviewed papers from independent practitioners that establish the therapy as possible. (2) The provider must send evidence of approval from an independent committee, such as an institutional review board (a document from the clinical entity where the therapy is being practiced that shows the steps taken to protect the patient and justifying the experimental or approved therapy for their specific disease). (3) The provider must send a document from an agency equivalent to the Food and Drug Administration showing the approval of the experiment or the therapy for human subjects with their disease. I advise them that without all three, they must assume they are receiving an unproven therapy and that the patient is in danger of risking their life or health, of losing their money, of being away needlessly from home, family, and friends, and of course, of not being therapeutically improved". "As President of the ISSCR, - he concludes - I propose that we develop a website and occasional press alert naming as unproven stem cell therapies where providers of socalled ‘‘therapies’’ cannot supply to the ISSCR, within 60 days of request, evidence of rigorous and independent scientific and ethical review along the lines of what I recommend patients seek". The minimum criteria by ISSCR, he explains, will be required to achieve nonlisting on the site (that is no list of accountable clinics will be supplied).

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