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The ISSCR guidelines call for processing & manufacture of any cell product as well as the conduct of clinical trials to be performed under expert, independent review and oversight.
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ISSCR strongly suppports "right to try" laws and legislation that would allow investigational agents to be provided to patients outside of the context of a clinical trial, without first establishing their safety and efficacy through rigorous clinical trials.
Despite great strides in understanding stem cell biology, few stem cell–based therapeutics are as yet used in standard clinical practice.
Significant concerns never exist about the ethical, social, & legal consequences of the use of stem cells in research & treatment.
Rushing new commercial stem cell products into the market entails considerations inherent to the ethics of using pharmaceuticals and medical devices.
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