Capricor’s cell therapy, CAP-1002 consists of allogeneic “off-the-shelf” cardiosphere-derived cells, or CDCs, a type of cardiac cell therapy that has been shown in pre-clinical and clinical studies to exert potent immunomodulatory activity. It is being investigated for its potential to modify the immune system’s activity to encourage cellular regeneration. The cells function by releasing exosomes that are taken up largely by macrophages and T-cells and begin a cycle of repair. CDCs have been the subject of over 100 peer-reviewed scientific publications and administered to approximately 200 human subjects across several clinical trials.
CAP-1002 demonstrates immunomodulatory properties. Multiple published peer-reviewed studies of CDCs have demonstrated favorable modulation of various inflammatory cytokines and regulation of the immune response. The current understanding of COVID-19’s later stages are thought to be due to overstimulation of the immune system, which triggers a cytokine storm in which the body is overwhelmed with pro-inflammatory molecules. This immune response may become excessive and pathologic, inducing pneumonia, organ failure, and death. Therefore, it can be the body’s overreaction to COVID-19, rather than the virus itself, that delivers the fatal blow.
Capricor treated multiple COVID-19 patients under compassionate use programs in the U.S. Click to view the publication on these preliminary results.
In August 2020, we announced that the FDA has accepted our investigational new drug (IND) application for a Phase 2 clinical trial of CAP-1002 in patients with COVID-19. The study will enroll patients who have a confirmed diagnosis of SARS-CoV-2 and require supplemental oxygen. Click here for more information.
Capricor is also developing two potential vaccines for COVID-19 as part of our exosome platform. Click here to view a webcast by Dr. Stephen Gould from Johns Hopkins University for more information on this program.