CardioCell adds Stony Brook University to sites conducting phase IIa trial
CardioCell, a Stemedica Cell Technologies subsidiary that designs allogeneic stem-cell therapies for cardiovascular indications, has expanded patient recruitment to Stony Brook University’s Heart Institute for its phase IIa clinical trial for chronic heart failure (HF). Recruitment for 20 qualified patients currently is underway at only Emory University in Atlanta, Northwestern University in Chicago, Stony Brook University on Long Island and the University of Pennsylvania in Philadelphia.
“The Heart Institute of Stony Brook University Medical Center is ideally suited for CardioCell’s chronic HF study,” said Dr. Sergey Sikora, CardioCell’s president and CEO. “The hospital delivers superior cardiovascular care to all of Long Island and surrounding areas, and its state-of the-art labs are staffed by experts at handling live cells like the itMSCs used in this study’s protocols.”
“For patients whose heart failure is due to blockages in their arteries, a number of therapies—including the use of cardiac stents and bypass surgery—have been available for decades,” said Dr. Hal Andrew Skopicki, Stony Brook University’s Heart Failure and Cardiomyopathy Program director and ventricular assist device co-director, as well as Principal Investigator for CardioCell’s New York study site. “For other patients whose heart failure is due to other causes, there currently are no approved therapies that specifically try to recover their failing heart function.”
CardioCell’s itMSCs secrete large numbers of cytokines and growth factors, and this FDA-approved clinical trial will test if these stem cell properties can cause the patient’s own cardiomyocytes to improve their ability to contract, eventually restoring or improving heart function.
Only CardioCell’s chronic HF therapies feature itMSCs, which are exclusively licensed from CardioCell’s parent company Stemedica. Unlike all other MSCs—which are grown under normoxic conditions—Stemedica’s bone-marrow-derived, allogeneic itMSCs are unique because they are grown under hypoxic conditions. In vitro experiments demonstrate cells that are exposed to hypoxic conditions show greater homing and engraftment than cells grown under normoxic conditions. Compared to other MSCs, itMSCs secrete higher levels of growth factors and other important proteins associated with neoangiogenesis and healing.
Founded in San Diego, California, in 2013, CardioCell is a global biotechnology company that explores therapeutic applications of unique, patented, ischemia-tolerant mesenchymal stem cells manufactured under cGMP conditions.