Oversight for clinical uses of autologous adult stem cells: lessons from international regulations.

Lysaght, Tamra; Kerridge, Ian; Sipp, Douglas; Porter, Gerard; Capps, Benjamin J · Cell Stem Cell · 2013

review · Level V

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Abstract

Autologous adult stem cells (ASCs) are being administered by physicians for indications that have not been demonstrated as safe and effective in formal clinical trials. Examination of regulatory frameworks across five countries suggests that balancing the demands of research with clinical freedom has created structural weaknesses that are being exploited.

Medical subject headings