New ISSCR Guidelines Underscore Major Principles for Responsible Translational Stem Cell Research

Abstract

The International Society for Stem Cell Research (ISSCR) task force that developed new Guidelines for the Clinical Translation of Stem Cells discusses core principles that should guide the responsible transition of basic stem cell research into appropriate clinical applications.

Regulating the therapeutic translation of regenerative medicine

“…Patient outcomes should be documented, as is done in Japan, and any adverse effects should be reported immediately as recommended by ISSCR guidelines [15]. This would provide a mechanism to gather empirical evidence to determine efficacy.…”

Stem cell therapies and regenerative medicine in China

“…While most stem cell interventions are documented to have no side effects, safety issues still require attention [35]. To advance clinical investigation and promotion of medical innovation while protecting patients and ensuring integrity in regenerative medicine, the International Society for Stem Cell Research (ISSCR) assembled an international group of scientists, surgeons, genetherapists, bioethicists, patient advocates, and attorneys to create ''The ISSCR Guidelines for the Clinical Translation of Stem Cells'' [36]. These guidelines articulate principles and standards as a guide for practitioners and regulatory bodies when considering if, when, or how to allow trials of experimental stem cell therapies in patients.…”

Mesenchymal Stem Cells as Immunomodulators in Transplantation

“…The clinical trial and the eventual cell therapeutic product is assessed and approved by a national regulatory agency, such as the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA).The International Society for Stem Cell Research (ISSCR) has published guidelines for the clinical translation of stem cells emphasising on the scientific, clinical and ethical issues that should be addressed for a responsible translation of basic stem cell research into suitable clinical applications. The guidelines give attention to the main areas of clinical translational stem cell research namely, cell processing and manufacture, the necessity of preclinical studies and clinical research promoting maximum safety and quality of the cells to be used (Hyun, Lindvall et al 2008). …”