Internet stem cell therapy providers – Coding Frame Purposes - Identify providers of stem cell therapies online, answering the basic questions: Who, what, for whom, how, and where. - Identify the intended consumer, and the means of appeal to this audience. - Characterize the expectations of stem cell therapeutics generated by these websites. - Assess the potential risk to public safety posed by premature DTC treatment provision over the internet. Inclusion – Websites offering stem cell therapeutics directly to consumers. Standard of coding – What a lay consumer would perceive. E.g.: risks that are hidden in a few case reports among many may be coded as “none are presented” (and/or “Risks may be inferred from the clinic’s case reports”). 1. Basic Information a. Name of organization b. Website URL c. Date of coding d. Date website accessed / archived e. Date website last updated f. Associated locations – specify g. Location’s associated activities Unspecified – 1 Contact information - 2 Location of incorporation - 3 Treatment centre - 4 2. Treatment Information a. Stem cell offerings Unspecified - 1 Embryonic stem cells (eSC) – 2 Fetal stem cells (fSC) – 3 Adult stem cells (aSC) – 4 Cord blood cells (cbSC) – 5 Stem cell adjuncts (e.g.: telomerase) – 6 b. Is stem cell therapy autologous, allogeneic, or xenogeneic? Unspecified - 1 Autologous – 2 Allogeneic – 3 Xenogeneic – 4 Does not apply, no stem cells are being provided – 5 c. Is the stem cell lineage specified? Not mentioned – 1 No, the cells are pluripotent – 2 Yes, e.g.: haematopoietic – 3 d. If yes, specify. e. Stem cell source Unspecified – 1 Yes, from fat – 2 Yes, from bone marrow – 3 Yes, from peripheral blood – 4 Yes, from aborted foetuses – 5 Yes, from donors – 6 Yes, other – 7 f. Are transplant processing or quality assurance procedures specified? No – 1 Yes – 2 g. Transplantation procedure Unspecified - 1 Yes, intravenous injection – 2 Yes, sub-cutaneous injection – 3 Yes, by mouth – 4 Yes, CSF – 5 Yes, surgical transplantation to organ of interest – 6 h. Is immune rejection of the graft addressed in the treatment protocol? No - 1 Yes, by HLA-matching - 2 Yes, by immunosupression - 3 i. Does the site note that the treatment is considered experimental by Western medical standards? No – 1 Yes – 2 j. Subjective impression: Any disclaimer noted above notwithstanding, is the treatment seen as being experimental, or routine/ready for routine access? Experimental – 1 Ambiguous – 2 Routine – 3 k. Adjunct therapies None mentioned – 1 Physical medicine and rehabilitation services – 2 Traditional/homeopathic medicines – 3 l. Treatment cost Unmentioned – 1 Mentioned, figures or ranges provided. – 2 m. If cost figures or ranges are provided, specify. (Figures rounded to nearest $10, Euro exchange rate taken to be 1.44 CAD.) 3. Stem cell science a. How the treatment works No explanation - 1 Don’t know, exactly - 2 Stem cells migrate to pathology – 3 Stem cells repair damaged tissue – 4 Stem cells replace damaged or depleted tissue - 5 Stem cells generate local environmental effects (e.g.: growth factor production) – 6 The stem cell infusion triggers or modulates self-healing – 7 Stem cells fuse with existing cells – 8 Stem cells have systemic effects – 9 b. Stem cells and disease: Site portrays a deficiency in a finite pool of stem cells as a major mechanism or contributor to disease. Not at all / Minimally – 1 Somewhat - 2 Prominently - 3 c. Is the treatment is portrayed as revolutionary, i.e.: a marked departure from current therapies? Not at all / Minimally – 1 Somewhat - 2 Prominently - 3 d. Is the treatment portrayed as the clinical application of routine or familiar procedures? Not at all / Minimally – 1 Somewhat - 2 Prominently - 3 e. The site appeals to holistic, natural, or magical powers of renewal Not at all / Minimally – 1 Somewhat – 2 Prominently – 3 f. The site appeals to the scientific deconstruction of health and illness Not at all / Minimally – 1 Somewhat – 2 Prominently - 3 g. Knowledge is portrayed as being incomplete or uncertain Not at all / Minimally – 1 Somewhat – 2 Prominently - 3 h. Knowledge is portrayed as being advanced or certain Not at all / Minimally – 1 Somewhat – 2 Prominently - 3 i. Claims are substantiated mainly by ... Claims are unsubstantiated – 1 Expert testimonial - 2 Expert consensus - 3 Participation in a local regulatory regime - 4 Association with professional or academic institutions - 5 Anecdotes or the clinic’s previous experience with the therapy -6 Patient testimonials - 7 Lay literature (e.g.: news articles) - 8 Case reports - 9 Abstracts or presentations at conferences or meetings - 10 Published works – 11 Organization’s participation in clinical trials or research – 12 4. Indications / Associated Coditions a. Manner of presetation None are presented. - 1 Treatable diseases may be inferred from the clinic’s case reports, anecdotes, news reports, or patient testimonials – 2 The site lists treatable or previously treated diseases – 3 b. There is the sense that indications for stem cell therapies is indeterminate (e.g.: by indeterminate vocabulary, “... and other conditions” or “Indications include ...”; or by over-broad disease categories; etc..) Not applicable – 1 Not at all / Minimally – 2 Somewhat – 3 Prominently – 4 c. Associated diseases – by organ system / pathology (Code autoimmune/rheumatic, cancer, or infection as 13, 14, and 15, respectively.) None - 1 Circulatory - 2 Digestive - 3 Endocrine - 4 Integumentary - 5 Musculoskeletal – 6 Nervous – 7 Psychiatric – 8 Reproductive - 9 Respiratory - 10 Urinary/Excretory - 11 Haematological, non-cancer (e.g.: anemia) - 12 Autoimmune/rheumatic - 13 Cancer - 14 Infectious diseases – 15 d. Are congenital diseases given as indications? (Congenital diseases are those present at birth, e.g.: cerebral palsy.) No - 1 Yes – 2 e. If yes, specify. f. Is “aging” an indication? No - 1 Yes - 2 g. Are cosmetic or lifestyle enhancement purposes given as indications? None - 1 Cosmetic - 2 General stress or fatigue - 3 Desire for health-enhancement, otherwise healthy - 4 h. Are any conditions or patients excluded? No - 1 Yes – 2 i. If yes, specify. 5. Benefits of treatment a. Manner of presentation None are presented. - 1 Benefits may be inferred from the clinic’s case reports, anecdotes, news reports, or patient testimonials – 2 The site lists or notes previous or potential benefits – 3 b. Treatment appears generally beneficial No - 1 Yes - 2 c. Associated benefits include No benefits are mentioned - 1 Improvement in disease state - 2 Physical rejuvenation (e.g.: improved vitality, better sleep) - 3 Mental rejuvenation (e.g.: improved cognition) - 4 Cosmetic enhancement - 5 Longer life – 6 d. Likelihood of benefits No benefits are presented – 1 Benefits are presented, but likelihood is not presented meaningfully - 2 Very unlikely (e.g.: rare) – 3 Unlikely - 4 Possible – 5 Likely - 6 Very likely (e.g.: certain) – 7 6. Risks of treatment a. Manner of presentation None are presented. - 1 Risks may be inferred from the clinic’s case reports, anecdotes, news reports, or patient testimonials – 2 The site lists or notes previous or potential risks – 3 b. Treatment appears generally safe No - 1 Yes - 2 c. Associated risks include No risks are presented – 1 Deterioration of disease state – 2 Immune rejection of stem cell graft – 3 Risks related to impure transplant materials (e.g.: infection) – 4 Surgical risks (e.g.: anaesthesia, infection) – 5 Graft versus host disease (GvHD) – 6 Teratoma or other cancer – 7 d. Likelihood of risks No risks are presented – 1 Risks are presented, but likelihood is not quantified - 2 Irrelevant or Very unlikely (e.g.: rare) – 3 Unlikely - 4 Possible – 5 Likely - 6 Very likely (e.g.: certain) – 7 7. Ethical issues a. Are social/ethical issues mentioned? None – 1 Issues related to the source of transplantation material (e.g.: moral status of the embryo) – 2 Issues related to the provision of unproven technologies – 3 Issues related to accessibility of health care – 4 b. Relevancy No social/ethical issues are mentioned – 1 Issues are irrelevant to the services provided – 2 Issues may or may no be relevant to the services provided – 3 Issues are relevant to the services provided – 4 8. Website aesthetics and intended audience a. This website appears to target Patients – 1 The general public – 2 Health professionals – 3 Policy-makers / health regulators – 4 Researchers – 5 b. Website appeal – the website appeals mainly through Cosmesis – 1 Curiosity – 2 Desperation/ Frustration with conventional medicine – 3 Health-enhancement – 4 Holism – 5 Normalization – 6 Technophilia (i.e.: a strong enthusiasm for technology) – 7 c. Visual style – the website is mainly ... Graphically oriented – the website features prominent decorative graphics and multimedia gadgets – 1 Both graphic and text orientations are important – 2 Text oriented – the website features prominent amounts of text – 3 Separate graphically oriented and text-oriented pages are available – 4 d. Language – the website’s language is mainly Easily interpreted by lay viewers – 1 A mix of technical and easily interpreted passages – 2 Technical – 3 Separate lay and technical pages are available – 4