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Von der Grundlagenforschung in die Klinik

Regulative Anforderungen an präklinische und klinische Studien mit Stammzellen

From basic research to the clinic. Regulations for preclinical and clinical studies with stem cells

  • Leitthema: Forschung mit humanen embryonalen Stammzellen
  • Published:
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz Aims and scope

Zusammenfassung

Ende 1998 wurde mit der ersten Isolierung und Kultivierung humaner embryonaler Stammzellen (humane ES-Zellen) eine stürmische Entwicklung in der Stammzellforschung eingeleitet, die bis heute von kontroversen Diskussionen begleitet wird. Adulte Blutstammzellen werden hingegen schon lange therapeutisch eingesetzt. Zunächst nach ihrer Entdeckung 1963 in Einzelfällen, bis sie Anfang der 1980er-Jahre Anerkennung als Zelltherapeutikum fanden. Der Weg von der Grundlagenforschung in die Klinik hat hier rund 20 Jahre gedauert und wurde anfangs sehr kontrovers diskutiert. Das damalige regulatorische Umfeld ließ jedoch eine rasche Umsetzung der Ergebnisse aus der Grundlagenforschung in die Klinik zu. Inzwischen befinden sich neue Stammzelltherapien für die Behandlung einer Vielzahl von Krankheiten in der Entwicklung. Vor ihrer klinischen Realisierung ist aber ein langer Entwicklungsweg zu durchlaufen, der über das Arzneimittelgesetz (AMG) geregelt ist. Sowohl für die vorklinische Forschung als auch für den klinischen Einführungsprozess gelten spezifische Regularien, die eine strukturierte und sichere Einführung neuer therapeutischer Maßnahmen gewährleisten sollen. Zeitaufwand, Know-how und Kosten für die Planung, Beantragung und Durchführung der Studien sind nicht zu unterschätzen. Erst nach Prüfung durch die zuständige Behörde und Erteilung einer entsprechenden Genehmigung dürfen Stammzellprodukte in den Verkehr gebracht werden.

Abstract

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.

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Authors and Affiliations

  1. Universität Rostock, Rostock, BRD

    Gustav Steinhoff

  2. Biomedizinisches Forschungszentrum Rostock, Rostock, BRD

    G. Tiedemann

  3. Ruprecht-Karls-Universität, Heidelberg, BRD

    M. Thalheimer & A. D. Ho

  4. Klinik und Poliklinik für Herzchirurgie, Medizinische Fakultät, Universität Rostock, Schillingallee 35, 18057, Rostock, BRD

    Gustav Steinhoff

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  1. Gustav Steinhoff
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  2. G. Tiedemann
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  3. M. Thalheimer
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  4. A. D. Ho
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Correspondence to Gustav Steinhoff.

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Steinhoff, G., Tiedemann, G., Thalheimer, M. et al. Von der Grundlagenforschung in die Klinik. Bundesgesundheitsbl. 51, 973–979 (2008). https://doi.org/10.1007/s00103-008-0624-4

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  • DOI: https://doi.org/10.1007/s00103-008-0624-4

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