Thursday, December 4, 2008

Guidelines for the Clinical Translation of SC

Guidelines for the Clinical Translation of Stem Cells, International Society for Stem Cell Research (ISSCR), December 3, 2008. Links are provided to the Guidelines [PDF], to Apppendix 1 (a Patient Handbook on Stem Cell Therapies) [PDF], to Appendix 2 (Additional Resources), to a Cell Stem Cell article summarizing the essential elements of the document [PubMed Citation] and to a joint ISSCR and Cell Stem Cell Press Release about the Guidelines.

For an article, in the same issue of Cell Stem Cell, that provides evidence that such Guidelines are needed, see: Stem Cell Clinics Online: The Direct-to-Consumer Portrayal of Stem Cell Medicine by Darren Lau and 5 co-authors, including Timothy Caulfield, Cell Stem Cell 2008(Dec 4); 3(6): 591-4. PubMed Abstract:
Despite the immature state of stem cell medicine, patients are seeking and accessing putative stem cell therapies in an "early market" in which direct-to-consumer advertising via the internet likely plays an important role. We analyzed stem cell clinic websites and appraised the relevant published clinical evidence of stem cell therapies to address three questions about the direct-to-consumer portrayal of stem cell medicine in this early market: What sorts of therapies are being offered? How are they portrayed? Is there clinical evidence to support the use of these therapies? We found that the portrayal of stem cell medicine on provider websites is optimistic and unsubstantiated by peer-reviewed literature.
See also: Laws needed to protect patients from stem cell clinics' exaggerated claims: study by Sheryl Ubelacker, Canadian Press, December 3, 2008. The first sentence:
Canadians should be "very skeptical" of foreign clinics that use websites to promote stem cell therapies for a wide range of medical conditions, warn researchers, saying there is a dearth of scientific evidence to back up their claims.
Comments: The Guidelines contain no explicit mention of cancer SC. However, if one accepts the prediction that "diagnostic methods based on the detection of CSC’s will have the potential to address key limitations of current methods" [excerpt from Business Wire, April 26, 2007], then some attention needs to be paid to the known limitations of diagnostic methods. Two examples of relevant references:

1) Grading quality of evidence and strength of recommendations for diagnostic tests and strategies by Holger J Sch√ľnemann and 10 co-authors, including Gordon H Guyatt, BMJ 2008(May 17); 336(7653): 1106-10 [PubMed Citation]. Excerpt from the publicly-accessible Extract:
Inferring from data on accuracy that a diagnostic test or strategy improves patient-important outcomes will require the availability of effective treatment, reduction of test related adverse effects or anxiety, or improvement of patients’ wellbeing from prognostic information.
Excerpt from the full text:
Although recommendations on diagnostic testing share the fundamental logic of recommendations on treatment, they present unique challenges.
2) See also: Evaluation of clinical innovation: a gray zone in the ethics of modern clinical practice? by Johane Patenaude and 4 co-authors, J Gen Intern Med 2008(Jan); 23(Suppl 1): 27-31 [PubMed Citation]. Excerpt for the Conclusions section of the (publicly accessible) full text:
Innovation is a neglected area for ethics assessment. Further studies on a larger scale are necessary to review the concepts of experimental, innovative, and commonly accepted care.
Perhaps a subsequent version of the ISSCR Guidelines should include a section on diagnostic tests involving CSC?

3 comments:

  1. Ricki Lewis, a fellow of the Alden March Bioethics Institute, posted a commentary, New Stem Cell Guidelines from ISSCR, on blog.bioethics.net (December 3, 2008). She included a summary, in point form, of some of the major recommendations of the ISSCR guidelines.

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  2. Also relevant: The Power of Hope, Ian Clarke, Connecting for Kids, December 2, 2008. Excerpt:

    When patients and families have no effective treatments for debilitating or even fatal diseases, they want hope. They deserve hope. Unfortunately what they are often receiving is extortion. Hope can make us blind to logic and ignore evidence contrary to the outcome we desire. The way forward in science is to do carefully controlled experiments and careful clinical trials. No new treatment comes without potential risks, if someone tells you a treatment is “risk free” they are likely not telling you the whole truth. The question is of balancing potential risks with potential benefits, and this is where the idea of “informed consent” has derived from. ...

    Found via: The International Society for Stem Cell Research warned against fraudulent clinics and treatments, Connecting for Kids, December 4, 2008.

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  3. See also: Stick to the guidelines and fewer get hurt by Monya Baker, Nature Reports Stem Cells 2008(Dec 11).

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