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      Professional Regulation: A Potentially Valuable Tool in Responding to “Stem Cell Tourism”

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          Abstract

          The growing international market for unproven stem cell-based interventions advertised on a direct-to-consumer basis over the internet (“stem cell tourism”) is a source of concern because of the risks it presents to patients as well as their supporters, domestic health care systems, and the stem cell research field. Emerging responses such as public and health provider-focused education and national regulatory efforts are encouraging, but the market continues to grow. Physicians play a number of roles in the stem cell tourism market and, in many jurisdictions, are members of a regulated profession. In this article, we consider the use of professional regulation to address physician involvement in stem cell tourism. Although it is not without its limitations, professional regulation is a potentially valuable tool that can be employed in response to problematic types of physician involvement in the stem cell tourism market.

          Highlights

          • Stem cell tourism is a complex and growing phenomenon that raises various concerns

          • Physicians play important roles in this market and are often professionally regulated

          • Key features of professional regulation make it well placed to respond

          • It is appropriate to use available tools to mitigate risks of stem cell tourism

          Abstract

          In this article, Zarzeczny and colleagues explore the use of professional regulation as a tool in responding to physicians’ involvement in the market for unproven stem cell-based interventions (“stem cell tourism”).

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          Most cited references33

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          Stem cell clinics online: the direct-to-consumer portrayal of stem cell medicine.

          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.
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            Angiomyeloproliferative lesions following autologous stem cell therapy.

            Some reports suggest that autologous hematopoietic stem cell transplantation holds potential for treatment of renal diseases such as lupus nephritis, but the safety of delivering various stem cell types (hematopoietic, mesenchymal, and endothelial precursors) is not well established. Here, we report a case of lupus nephritis treated by direct renal injection of autologous stem cells recovered from peripheral blood. The patient developed masses at the sites of injection and hematuria. We suspected transitional cell carcinoma but nephrectomy revealed that the masses were angiomyeloproliferative lesions. We believe that this previously undescribed pathologic entity is stem cell-derived or -induced. The biologic potential, including the neoplastic potential, of this lesion is unknown. This case illustrates that the development of angiomyeloproliferative lesions is a possible complication of stem cell therapy.
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              Cellular transplants in China: observational study from the largest human experiment in chronic spinal cord injury.

              In China, fetal brain tissue has been transplanted into the lesions of more than 400 patients with spinal cord injury (SCI). Anecdotal reports have been the only basis for assuming that the procedure is safe and effective. To compare available reports to the experiences and objective findings of patients who received pre-operative and postoperative assessments before and up to 1 year after receiving cellular implants. Independent observational study of 7 chronic SCI subjects undergoing surgery by Dr Hongyun Huang in Beijing. Assessments included lesion location by magnetic resonance imaging, protocol of the American Spinal Injury Association (ASIA), change in disability, and detailed history of the perioperative course. Inclusion and exclusion criteria were not clearly defined, as subjects with myelopathies graded ASIA A through D and of diverse causes were eligible. Cell injection sites did not always correlate with the level of injury and included the frontal lobes of a subject with a high cervical lesion. Complications, including meningitis, occurred in 5 subjects. Transient postoperative hypotonicity may have accounted for some physical changes. No clinically useful sensorimotor, disability, or autonomic improvements were found. The phenotype and the fate of the transplanted cells, described as olfactory ensheathing cells, are unknown. Perioperative morbidity and lack of functional benefit were identified as the most serious clinical shortcomings. The procedures observed did not attempt to meet international standards for either a safety or efficacy trial. In the absence of a valid clinical trials protocol, physicians should not recommend this procedure to patients.
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                Author and article information

                Contributors
                Journal
                Stem Cell Reports
                Stem Cell Reports
                Stem Cell Reports
                Elsevier
                2213-6711
                31 July 2014
                31 July 2014
                09 September 2014
                : 3
                : 3
                : 379-384
                Affiliations
                [1 ]Johnson-Shoyama Graduate School of Public Policy, University of Regina, Regina, SK S4S 0A2, Canada
                [2 ]Faculty of Law and School of Public Health, Health Law Institute, University of Alberta, Edmonton, AB T6G 2H5, Canada
                [3 ]Faculties of Law and Pharmacy and Pharmaceutical Sciences, Health Law Institute, University of Alberta, Edmonton, AB T6G 2H5, Canada
                [4 ]Department of Family Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB T6G 2R7
                [5 ]Department of Geography, Simon Fraser University, Burnaby, BC V5A 1S6, Canada
                [6 ]Health Law Institute, University of Alberta, Edmonton, AB T6G 2H5, Canada
                [7 ]Alden March Bioethics Institute, Albany Medical College, Albany, NY 12208-3478, USA
                [8 ]Faculty of Health Sciences, Simon Fraser University, Burnaby, BC V5A 1S6, Canada
                Author notes
                []Corresponding author amy.zarzeczny@ 123456uregina.ca
                Article
                S2213-6711(14)00202-1
                10.1016/j.stemcr.2014.06.016
                4266009
                25241736
                4c101183-7776-41ab-aeeb-74a375c2651a
                © 2014 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).

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