A Protocol for a Phase I/II Trial to Evaluate Safety and Efficacy of Autologous Stem Cells Embedded in a Nanogel Patch for Patients with Heart Failure Undergoing Coronary Artery Bypass Graft

Introduction: Heart failure affects numerous patients and carries a 50% 5-year mortality rate from the time of diagnosis. Current treatment is based on medication, device therapy and revascularization to reduce morbidity and mortality. However, stem cell therapy could improve cardiac function and outcomes, using a nanogel patch during coronary bypass graft. Methods: An open label phase I/II trial consisting of an initial sentinel approach to test safety, followed by a randomized approach to test efficacy. Discussion: Preclinical studies have shown safety of nanogel patches and clinical trials showed promise using mesenchymal stem cells. New approaches could contribute to the improvement of morbidity and mortality. Mesenchymal stem cell implantation with a nanogel patch could represent an effective and innovative therapeutic approach for patients with heart failure and reduced ejection fraction