Our allogeneic CSC (cardiac stem cells)-based products are derived from our proprietary platform designed to exploit the regenerative potential of stem cells found in cardiac tissue. Starting from myocardial muscle obtained from donor tissue that would typically be discarded during a routine valve replacement operation, the CSCs are isolated and then expanded in vitro.
Adult allogeneic cardiac stem cells have been shown to have strong cardio-protective and immune-regulatory properties. In vivo studies suggest that AlloCSC-01 has cardio-reparative potential by activating endogenous regenerative pathways and by promoting the formation of new cardiac tissue. In addition, AlloCSC-01 has displayed a strong tropism for the heart enabling a high retention of cells in the myocardium after intracoronary administration.
MECHANISM OF ACTION (MoA)
We believe that the mechanism of action of CSCs relies on three potential biological pathways:
- Cardioprotection of damaged tissue: secretion of protective factors by the cells in the recently damaged cardiac tissue could reduce cell death caused when both blood flow is interrupted and when it is restored, thus salvaging valuable tissue.
- Modulation of the immune response to reduce scarring in the cardiac tissue in the infarcted region and dampen the effects of chronic inflammation and
- Support of the inherent regeneration of myocardial tissue, improving the functional capacity of the myocardium.
Our CSC-based product candidates are manufactured in Spain by a sub-contractor, which has been approved by the Spanish Medicines and Medical Devices Agency as being compliant with cGMP requirements, based on a manufacturing process developed by Coretherapix.
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