The first part (Phase I/IIa) of the CAREMI clinical trial concluded in November 2015, as announced by Dr. Antonio Bernad, researcher at the Centro Nacional de Biotecnología of the CSIC (CNB-CSIC) and project coordinator. In this first phase, 55 patients have been treated with AlloCSC-01, a new product based on cardiac stem cells isolated from donor hearts. All will be monitored regularly over the next year to ensure the effectiveness and safety of the treatment. The final results of the study are expected in the first half of 2017.
Alloc C-01 was developed by Coretherapix (part of the Tigenix group). According to Bernad, preclinical results are positive. "It seems that AlloCSC-01 administration in the first week after infarction limits pathological remodelling and promotes cardiac regeneration. But we will have to wait at least a year for conclusive results," explains the researcher.
Several clinical centers are participating in the trial, under the coordination of Prof. Francisco Fernández Avilés at the Hospital Gregorio Marañón in Madrid. "Thanks to the cooperation and efforts of the participating hospitals, recruitment was completed in a shorter time than anticipated, successfully overcoming the challenges of an acute condition and the use of a novel treatment, and setting a precedent in the field cell therapy," said the doctor. The trial was funded by the European Union Seventh Framework Programme and is coordinated by the National Centre for Cardiovascular Research (CNIC).
The trial is part of the CARE-MI consortium, which has worked for the past five years to develop a product that limits tissue damage, based on the heart’s natural ability for repair.
Among the participating clinical centres, in addition to the Hospital Gregorio Marañón, are the Hospital UZ Leuven in Belgium, coordinated by Prof. Stefan Janssens, the Hospital of Navarre, Valladolid University Hospital, University Hospital Donostia, University Hospital Salamanca, Valencia University Hospital, Hospital Vall d'Hebron in Barcelona and the Hospital Virgen de la Victoria in Malaga, all in Spain.