Month: July 2016

Stem cells from bone marrow delay diabetes type I progression

In diabetes type I, there is a progressive decline of insulin-producing pancreatic beta cells, which is caused by the development of immune response directed to autoantigens of pancreatic islets. In advanced diabetes, the patient is completely dependent on exogenous insulin. Therefore, a medical team from Uppsala University Hospital has conducted a clinical trial on the application of autologous bone marrow mesenchymal stem cells (MSC) with the aim of inhibiting progression of diabetes.

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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 …