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©2021 by The International Society for Stem Cell Research. All rights reserved.

No part of this document may be produced in any form without written permission of The International Society for Stem Cell Research.

3. Clinical Translation of Stem Cell-based Interventions

This section highlights the scientific, clinical, regulatory, ethical, and social issues that should be addressed so that basic stem cell research is responsibly translated into appropriate clinical applications.

The rapid advances in stem cell research and genome editing technologies have created high expectations for the promise of regenerative medicine and gene- and cell-based therapies. As the field advances, it is important to balance the excitement from patients, scientists, clinicians, and the media over the growing number of clinical trials for serious diseases with the requirement to rigorously evaluate the safety and effectiveness of each potential new intervention. There have been instances where some clinical applications and clinical trials occurred far in advance of what is warranted by sound, rigorous, and dispassionately assessed preclinical evidence. Clinical experimentation is burdensome for research subjects and expensive; therefore, new interventions should only advance to clinical trials when there is a compelling scientific rationale, a plausible mechanism of action, and an acceptable chance of success. Furthermore, the safety and effectiveness of new interventions must be demonstrated in well-designed and expertly-conducted clinical trials with approval by regulators before the interventions are offered in direct-to-consumer settings to patients or incorporated into standard clinical care. Finally, any premature clinical testing of a promising new technology may jeopardize its further development if some adverse event emerges due to inadequate trial design or product manufacturing. Stem cell science is best positioned to fulfill its potential by adhering to a commonly accepted and robust set of guidelines for evidence-based therapy development. 

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