The cell therapy company CardioCell LLC has completed enrolling 23 patients for its Phase 2a chronic heart failure trial. These subjects were enrolled at Emory University in Atlanta, GA, MedStar Washington Hospital Center in Washington DC, and three other hospitals.
This study has the ponderous title of “Single-blind, Placebo-controlled, Crossover, Multicenter, Randomized Study to Assess the Safety, Tolerability and Preliminary Efficacy of Single Intravenous Dose of Ischemia-tolerant of Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-ischemic Etiology.”
This clinical trial will examine the safety of CardioCell’s proprietary ischemic-tolerant mesenchymal stem cells in heart failure patients. The trial will also test the ability of these cells to improve the heart function of these safe patients.
Ischemia-resistant mesenchymal stem cells have are extracted from bone marrow and then subjected to harsh cell culture conditions that toughen them up and improves their therapeutic capacities.
Cardiologist Javed Butler said that this clinical trial has been designed to use this novel intervention in a carefully selected group of patients who met rigorous inclusion and exclusion criteria.
This trial will deliver ischemia-tolerant mesenchymal stem cells (itMSCs) by means of intravenous infusion into heart failure patients and then monitor these patients to determine if the itMSC-treated patients show signs of improvement in heat function.
These itMSCs are licensed under the parent company Stemedica and these are allogeneic cells that were isolated from young, healthy donors and grown under hypoxic conditions. Once grown under these harsh culture conditions, the itMSCs increase their ability to home to damaged tissues and engraft into those tissues. itMSCs also secrete increased levels of growth and trophic factors that promote neurogenesis and tissue healing.