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Stem Cell Therapies: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings - A Workshop

Completed

The Institute of Medicine and the National Academy of Sciences co-hosted this workshop with the International Society for Stem Cell Research in order to take a critical look at the practice of unproven stem cell treatments. Speakers examined the evidence base of unsubstantiated treatment offerings and the associated research and clinical risks and concerns. Discussions delved into legal hurdles for establishing standards and criteria to govern stem cell trials and treatments and explored a range of potential solutions for assuring the quality of unregulated therapies.

Description

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.

Contributors

Committee

R. A. Charo

Chair

Robin Ali

Member

I. Glenn Cohen

Member

Ellen G. Feigal

Member

Fred H. Gage

Member

Lawrence S. Goldstein

Member

Geoff MacKay

Member

Amy C. Rick

Member

Irving L. Weissman

Member

Sponsors

Department of Health and Human Services

Private: Non Profit

State or Local

Staff

Adam Berger

Lead

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