The European Medicines Agency has released new guidance on medicines based on stem cells. The guidance covers the different types of stem cells used in medicines, and the considerations that companies need to take into account when developing medicines including stem cells or developed from stem cells.
The reflection paper on stem cell-based medicinal products stresses the fact that companies developing medicines including stem cells need to pay close attention to the way the medicines are manufactured, to make sure that the final medicine is as consistent and reproducible as possible.
Pre-clinical and clinical testing also needs to take account of the cells' properties, ensuring that the possible risks of tumour development and rejection by the body are studied adequately and balanced against their benefits for patients.
Stem cells are naturally occurring cells in the body that have the ability to divide and produce a range of different cell types. The use of stem cells as medicines is a promising area of research as they may be able to help the body to regenerate damaged or lost tissue in diseases like Parkinson’s disease, multiple sclerosis, heart disease, liver disease, spinal cord damage or cancer.
The reflection paper was adopted by the Agency's Committee for Advanced Therapies (CAT) on 14 January 2011. This followed a public consultation between March and June 2010 (see the overview of comments received) and discussion at a public workshop in May 2010 involving 230 participants from academia, industry and regulatory authorities.