We offer advice and support* for researchers and companies who would like to conduct a clinical study in the field of regenerative medicine. This can include support with preparation of a project description, IMPD, help with regulatory questions with an ATMP study, or access to GMP premises.
About regenerative medicine
Regenerative medicine is a relatively new area beginning in the early 1990s. Briefly, it means replacing or restoring organs or tissues to their normal function. Stem cells can help with this. Stems cells have the ability to develop into different cell types and proliferate, and can therefore be used in regenerative medicine to replace damaged tissues or stimulate the body’s own healing process. A lot of research conducted within the field of stems cells and regenerative medicine has the capacity to help patients with rare diseases who currently lack treatment. Today, regenerative medicine is used in bone marrow transplantation, cartilage transplantation, and skin transplantation.
Cell-based therapies, advanced therapy medicinal products (ATMP), are regulated by the European Medicines Agency (EMA). To be classified as an ATMP, the product must be based on genes, cells, or tissue.
Would you like to know more?
For more information about Regenerative medicine/ATMP as well as current courses/seminars within the area, please visit the site: www.atmpsweden.se
You can read more about Regenerative medicine in Gothenburg in our information brochure. The brochure was created in collaboration with Ann Novotny, Gothia Forum, and Iris Öhrn, Business Region Göteborg. Link to the brochure >>
SWElife’s project in cell therapy has, among other things, resulted in a process map for advanced therapy drugs (ATMP). This generic process map describes the development of an ATMP from pre-clinic to clinic and is intended to serve as support for those working with ATMP. Link to the process map (pdf) >>
*Gothia Forum’s project within regenerative medicine is financed by Regionalutvecklingsnämnden (RUN 612-01441-2016: (Swedish) Regenerativ medicin- utveckling av stödfunktioner för regional utveckling inom terapiområdet)