[From basic research to the clinic. Regulations for preclinical and clinical studies with stem cells].
The discovery of human embryonic stem cells at the end of 1998 had a strong influence on the development of stem cell research and led to controversial discussions. The first therapeutic application of adult blood stem cells began after their discovery in 1963 and was accepted as an authorized therapy in the early 1980s. The way from basic research to therapeutic use needed about 20 years and was also discussed in a controversial way similar to the discussions of today. The regulatory environment at that time, however, allowed a quick translation of the results from basic research to the clinic. Today many new stem cell therapies for a multitude of diseases are under development. Their clinical realization is regulated by the AMG (Arzneimittelgesetz). For nonclinical research as well as for clinical research, specific regulations are enacted to guarantee a structured and safe launch. Time, know how and money for planning, request for authorization and conduction of a clinical trial should not be underestimated. For clinical application of stem cell products authorization by the proper authorities is mandatory.
Steinhoff
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G
Medizinische Fakultät, Klinik und Poliklinik für Herzchirurgie, Universität Rostock, Rostock, BRD. gustav.steinhoff@med.uni-rostock.de
Tiedemann
G
G
Thalheimer
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M
Ho
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AD
D000328:Adult; D033041:Embryo Research / Q000941:ethics* / Q000331:legislation & jurisprudence*; D053595:Embryonic Stem Cells; D017041:Ethics Committees / Q000941:ethics / Q000331:legislation & jurisprudence; D032984:Ethics, Research; D015316:Genetic Therapy / Q000941:ethics / Q000331:legislation & jurisprudence; D005858:Germany; D018380:Hematopoietic Stem Cell Transplantation / Q000941:ethics / Q000331:legislation & jurisprudence; D006412:Hematopoietic Stem Cells / Q000166:cytology; D006801:Humans; D033581:Stem Cell Transplantation / Q000941:ethics / Q000331:legislation & jurisprudence; D023822:Tissue Engineering / Q000941:ethics / Q000331:legislation & jurisprudence