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CASCS stands for cardiac atrial stem cells. It is an investigational cell therapy, meaning it is not yet an authorised medicine. The substance is classified in the registry as a structurally diverse substance of cell therapy origin.[1] CASCS has no marketing authorisation in the product records, and the company supplying the product is CASC8 BV.[1] The only product name listed is "Cardiac atrial stem cells".
The registry data do not describe a molecular mechanism of action for CASCS. It is a cell therapy, which means it consists of living cells rather than a chemically synthesised molecule. The cells are allogeneic, meaning they come from a donor rather than from the patient being treated.[1] The planned trial did not state how the cells are expected to improve heart function; its stated purpose was to evaluate safety by measuring major adverse cardiac events.[1]
CASCS is prepared as a cell suspension for direct intramyocardial injection. The route of administration is intramyocardial, meaning the cells are injected directly into the heart muscle. In the planned trial, the injection was to be given per operatively, during surgery.[1]
Only one clinical trial of CASCS is registered in the EU Clinical Trials Information System. It was a Phase 1/2 interventional study titled "A Phase I-IIa Trial on the Safety and Preliminary Effectiveness of Intramyocardial Injection of Allogeneic Cardiac Atrial Stem Cells for the Treatment of Heart Failure".[1] The trial planned to enroll 20 participants.[1] Its primary outcome was major adverse cardiac events (MACE), defined as death and cause of death, re-admissions and cause of re-admission, myocardial infarction, and tumour formation.[1] The trial status is withdrawn, meaning it was stopped before participants were enrolled.[1] Because the trial was withdrawn, no results are available.
No side effects are reported in the registry data. The withdrawn trial planned to monitor for major adverse cardiac events, including death, re-admission, myocardial infarction, and tumour formation, but no safety data were collected because the study did not proceed.[1]
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