Strategic working groups  Clinical trials

Clinical trials and regulatory affairs


 

Initiators: Zoltán Ivics (Langen), Andreas Kurtz (Berlin), Torsten Tonn (Dresden), and Hans-Dieter Volk (Berlin)

Translation of stem cell research into clinical trials requires an adequate, transparent and scientifically sound regulatory framework, which considers the specifics associated with stem cells, their manufacturing and mode of action. This framework includes specific ethical principles and satisfactory re-imbursement mechanisms.  By forging a link between stem cell researchers, clinicians, industry, regulatory and health care providers, the platform will develop guidance and advise towards developing this framework.

The key questions of this WG will be:

    • Is the current regulatory framework sufficient or are there potential gaps (e.g. for iPSCs)? 
    • What are the safety and efficacy aspects and what is the mode of action? 
    • Which are the criteria for inclusion and the proper controls?
    • Clinical trial reporting and monitoring requirements?
    • Needs for stem cell clinical trial and reimbursement framework?
    • International harmonization and standards? 
    • Stem cell tourism and regulation? (in collaboration with WG "Patient information")

 

Further Information:

 Stem cells needs flexible rules - Interview Egbert Flory (GSCN Annual Magazine 2015/16)

 Regulatory viewpoints (Cell & Gene Therapy Insights)

 Information on clinical trails worldwide at ClinicalTrials.gov

 Informations about clinical studies in Germany (KKS Netzwerk)

 NEW: ISSCR Releases Updated Guidelines for Stem Cell Science and Clinical Translation (ISSCR, 2016)

 Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014, Dresden: Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market (Transfusion Medicine and Hemotherapy, Karger GmbH)

Recent reviews in Cell Stem Cell
 Stem Cell Therapies in Clinical Trials: Progress and Challenges
by Alan Trounson and Courtney McDonald

 From Dish to Bedside: Lessons Learned While Translating Findings from a Stem Cell Model of Disease to a Clinical Trial
by John McNeish, Jason P. Gardner, Brian J. Wainger, Clifford J. Woolf, and Kevin Eggan

 
Max Delbrueck Center for Molecular Medicine Berlin Stem Cell Network North Rhine Westphalia Partner Organizations Federal Ministry of Education and Research VDI Technologiezentrum
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