Human brain tissue in a dish: Young cerebral organoid generated from human iPSCs (Green: proliferative cells, White: neural progenitor cells, Red: neurons) [Copyright: Max Planck Institute for Molecular Biomedicine, Muenster]

Translation

Further information

Below you can find a compilation of documents relevant for translational research:

Guidelines for Stem Cell Research and Clinical Translation, International Society for Stem Cell Research (ISSCR)
Advice for drug development (e.g. regarding regulatory requirements) at the Paul-Ehrlich-Institut
Decision tree ATMP classification
Medicinal Products Act (translation of Arzneimittelgesetz – AMG)
Guidelines on Human Cell-based Medicinal Products, European Medicines Agency (EMA)
Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products, EMA

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