To limit the damage and to better repair the heart muscle following an infarct, numerous clinical trials have attempted cardiac tissue regeneration with stem cell therapy. Results of larger randomized, controlled studies have been generally disappointing. Recardio’s approach consists of a new regenerative alternative.
Recardio has shown that stem cell homing and retention as well as an improvement in cardiac output are possible using an in-vivo approach that does not rely on the collection, processing, and injection of stem cells to the heart. First, G-CSF, a cytokine that has been used clinically with success for three decades, is given to mobilize bone marrow stem cells in great numbers into circulating blood. Second, our lead candidate dutogliptin is administered over several days. Dutogliptin inhibits DPP-IV which enables the sustained preservation of SDF-1, a chemokine that is critical for homing of stem cells to the site of injury. This is a crucial step as numerous clinical studies have shown that G-CSF alone does not lead to a clinical improvement in this condition. The combination of G-CSF with dutogliptin significantly enhanced survival and reduced infarct size in a pre-clinical model. The clinical evaluation of this therapy is now under way in Recardio’s lead clinical program
The approach with G-CSF and dutogliptin is practical and reproducible. Once the diagnosis of AMI is confirmed and PCI and stent implantation are completed, patients receive daily injections of dutogliptin for 2 weeks in combination with G-CSF for 5 days. Due to its simplicity, this therapeutic strategy can be applied in a wide spectrum of healthcare facilities. Stem cell collections, processing, and reinfusion are not required.