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")