News related to Regenerative Medicine, Tissue Engineering, Medical devices, Pharmaceutical industry with focus on achievements and the legal, ethical, and regulatory aspects of the field

ISSCR publishes guidelines for stem cell science

The International Society for Stem Cell Research (ISSCR), an international organization that gathers scientists from the area of stem cells, is currently preparing a document, that will provide information on good practices in stem cell research and stem cells based experimental therapies. Draft of the document has been already posted on-line but now the organization it accepting comments from the scientific community before publishing the final version.

The draft version gives recommendations on the procedures of tissues donation for stem cell isolation, in particular it provides guidelines on the information which should be provided to the donor. For example the donor should be informed if the cells would be genetically manipulated or used commercially in allogenic transplants. The donor should be tested for infectious agents and genetic diseases.

The isolated cells must be expanded in a Good Manufacturing Practice (GMP) compliant laboratory, which enforces strict testing of the cells at all stages of manufacturing. Furthermore, animal-derived additives used in the production process should be replaced by human-derived supplements or by chemically-defined substances. If the process of cellular product preparation involves extensive cell manipulations in vitro, for example prolonged culture or genetic modification, the tumorigenic potential and genetic integrity of cells should be checked.

The document also rises specific issues on the acquisition of embryonic stem cell and induced pluripotent stem cell lines. The document will be published for the purpose of guidance only and will not provide compulsory regulations. However, the policymakers in particular countries might include some of the recommendations in the relevant legal acts.


MedTech Europe help for Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union

The “Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union” …

KOMUNIKAT KOMISJI Wytyczne w sprawie przyjęcia odstępstw ogólnounijnych dotyczących wyrobów medycznych zgodnie z art. 59 rozporządzenia (UE) 2017/745

Rozporządzenie Parlamentu Europejskiego i Rady (UE) 2017/745 w sprawie wyrobów medycznych przyjęto dnia 5 kwietnia 2017 …

EMA warns against using unproven cell-based therapies

EMA’s Committee for Advanced Therapies (CAT) is advising patients and the general public against using unregulated cell-based …