Currently Skimming:
6 Moving Forward
6 Moving Forward
Pages 49-54
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From page 49... ...
. BOX 6-1 Proposed Solutions to Challenges Encountered with Unproven Stem Cell Therapies as Suggested by Individual Speakers Ensuring Patient Safety and Providing Factual Information • Patients need to be protected from fraudulent therapies, but that can be done while also promoting safe and effective treatments based on rigorous science.
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From page 50... ...
Global Approaches • International societies working with government agencies could offer a useful global strategy for regulating stem cell therapies, perhaps through multi-site international clinical trials. (Miyata, Riley)
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From page 51... ...
David Vladeck of the Georgetown University School of Law warned, however, against moving toward harmonizing global regulatory standards, arguing that this may constrain rather than spur the development of new products. Timothy Caulfield of the University of Alberta agreed that safety is critical but also pointed to efficacy.
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From page 52... ...
Arellano agreed that clinics and other enterprises should voluntarily give information to regulators that they gather from patients. A family with a desperately sick child may be tempted to take college education savings and spend that money on an unproven stem cell therapy instead, Van Bokkelen continued.
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From page 53... ...
An organization should be collecting positive information and helping patients. "The most productive thing that could be done is to help patients sort through the clinical trials that have shown efficacy." Certifying clinics would be another way to help patients make decisions on receiving stem cell treatments, Phelan said.
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From page 54... ...
A CONTINUED DIALOGUE In his closing remarks, Fineberg emphasized the opportunity for a higher order of collaboration across the scientific, clinical, and patient communities. Continued dialogue and a clearer definition of needs could hasten the arrival of demonstrably effective stem cell therapies, he said.
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