Month: August 2015

Allogeneic Mesenchymal Stem Cells – safety and efficacy

Mesenchymal stem cells (MSC) isolated from bone marrow or adipose tissue are usually being used in clinical trials in an autologous settings, i.e. the patient receives his own cells. Intra-articular injections of autologous MSC were proved to be effective in the treatment of knee osteoarthritis. MSC isolated from the patient’s bone marrow or adipose tissue reduced pain 3 to 6 months after treatment when injected intra-articulary.

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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 …