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Suggested Citation:"Appendix C: Statement of Task." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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C

Statement of Task

An ad hoc planning committee will plan and conduct a public workshop to examine and discuss stem cell tourism. The goal of the workshop will be to examine the extent of unsubstantiated stem cell therapy offerings, the potential risks involved, the evidentiary basis for claims of efficacy, and to discuss whether there is a need for coordinated efforts to regulate stem cell clinic offerings globally. One issue that will be considered at the workshop is whether the information available to the public is adequate to sort out options. The workshop will advance discussions among a broad array of stakeholders, which may include government officials, industry representatives, professional societies, academic researchers, regulators, providers, and patients. The planning committee will develop the workshop agenda, select and invite speakers and discussants, and moderate the discussions. An individually authored summary of the workshop will be prepared by a designated rapporteur in accordance with institutional policy and procedures. This workshop will be held jointly with the International Society for Stem Cell Research.

Suggested Citation:"Appendix C: Statement of Task." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Suggested Citation:"Appendix C: Statement of Task." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Page 79
Suggested Citation:"Appendix C: Statement of Task." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Page 80
Next: Appendix D: Registered Attendees »
Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research Get This Book
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 Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research
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Stem cells offer tremendous promise for advancing health and medicine. Whether being used to replace damaged cells and organs or else by supporting the body's intrinsic repair mechanisms, stem cells hold the potential to treat such debilitating conditions as Parkinson's disease, diabetes, and spinal cord injury. Clinical trials of stem cell treatments are under way in countries around the world, but the evidence base to support the medical use of stem cells remains limited. Despite this paucity of clinical evidence, consumer demand for treatments using stem cells has risen, driven in part by a lack of available treatment options for debilitating diseases as well as direct-to-consumer advertising and public portrayals of stem cell-based treatments. Clinics that offer stem cell therapies for a wide range of diseases and conditions have been established throughout the world, both in newly industrialized countries such as China, India, and Mexico and in developed countries such as the United States and various European nations. Though these therapies are often promoted as being established and effective, they generally have not received stringent regulatory oversight and have not been tested with rigorous trials designed to determine their safety and likely benefits. In the absence of substantiated claims, the potential for harm to patients - as well as to the field of stem cell research in general - may outweigh the potential benefits.

To explore these issues, the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research held a workshop in November 2013. Stem Cell Therapies summarizes the workshop. Researchers, clinicians, patients, policy makers, and others from North America, Europe, and Asia met to examine the global pattern of treatments and products being offered, the range of patient experiences, and options to maximize the well-being of patients, either by protecting them from treatments that are dangerous or ineffective or by steering them toward treatments that are effective. This report discusses the current environment in which patients are receiving unregulated stem cell offerings, focusing on the treatments being offered and their risks and benefits. The report considers the evidence base for clinical application of stem cell technologies and ways to assure the quality of stem cell offerings.

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