TiGenix has found in its acute hearth attack study that allogenic cardiac stem cells can be transplanted safely through the coronary tree.
The Belgian biopharmaceutical company on Monday reported top-line one-year results from the CAREMI clinical trial, an exploratory Phase I/II study of AlloCSCs in acute myocardial infarction (AMI), better known as heart attack.
No mortality and major cardiac adverse events (MACE) have been found at 6 months or 12 months follow-up and a larger reduction in infarct size was found in one pre-specified subgroup associated with poor long-term prognosis and representing more than half of the patient population of the randomization phase of the study. Also, no immune-related adverse events have been recorded at one-year follow-up.
CAREMI is the first-in-human clinical trial with the primary objective being safety and evaluating the feasibility of an intracoronary infusion of 35 million of AlloCSCs in patients with AMI and left ventricular dysfunction treated within the first week post-AMI. Importantly, the trial is the first cardiac stem cell study to integrate a highly discriminatory magnetic resonance imaging (MRI) strategy to select patients at increased risk of heart failure and late adverse outcomes. CAREMI was not powered to establish efficacy therefore no conclusion can be drawn on the secondary efficacy end-points, the company said.
Professor Fernández-Avilés, Head of the Department of Cardiology at the Hospital General Universitario Gregorio Marañón in Madrid (Spain), principal investigator on the trial in Spain said that it was encouraging that no cardiac or immunological side effects.
The main investigator in Belgium, Professor Janssens, Head of the Department of Cardiovascular Diseases, University Hospital, Leuven, said: “This is the first study in which we have used a state of the art comprehensive MRI analysis to include patients with a large myocardial infarction in an innovative cell therapy protocol. Serial MRI analysis and extensive immunological profiling will allow us to further explore the encouraging signals we observed in cell treated patients with the worst MRI signature. These findings offer an exciting prospect for targeted follow-up studies in these high-risk patients.”