Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunities.

Background: In 2014, the European Clinical Trials Regulation was drawn up by the European Commission to replace the Clinical Trials Directive. The new Regulation aims to solve the shortcomings revealed by the Directive, such as extensive timelines and high bureaucratic costs, while increasing standards for safety and transparency of clinical trials. Importantly, the Regulation also points at harmonizing procedures among European Member States.

Follistatin-like 1 promotes proliferation of matured human hypoxic iPSC-cardiomyocytes and is secreted by cardiac fibroblasts.

The human heart has limited regenerative capacity. Therefore, patients often progress to heart failure after ischemic injury, despite advances in reperfusion therapies generally decreasing mortality. Depending on its glycosylation state, Follistatin-like 1 (FSTL1) has been shown to increase cardiomyocyte (CM) proliferation, decrease CM apoptosis, and prevent cardiac rupture in animal models of ischemic heart disease.