CardioCell LLC announced that it has received FDA approval for its investigational new drug (IND) application for a U.S.-based Phase IIA clinical study evaluating its allogeneic stem-cell therapy for patients with chronic heart failure (CHF).
Dr. Sergey Sikora, CardioCell’s president and CEO, said, “With the FDA’s IND approval, CardioCell is pleased to proceed with a Phase 2a CHF clinical trial based on the safety data reported in previous clinical trials using our unique, hypoxically grown stem cells. At the study’s conclusion we will understand if our therapy produces signs of improvement in a population of patients with dilated CHF, a condition largely unaddressed by current therapies. Dilated CHF is characterized by a viable but non-functioning myocardium in which cardiomyocytes are alive but are not contracting as they should. We hope that unique properties of our itMSCs will transition patients’ cardiomyocytes from viable to functioning, eventually improving or restoring heart function.”
The company has developed an ischemic tolerant mesenchymal stem cells (itMSC) treatment for the type of dilated CHF that is not related to coronary artery disease. The treatment could potentially apply to about 35 percent of CHF patients. Only CardioCell’s CHF therapies feature itMSCs, exclusively licensed from CardioCell’s parent company Stemedica Cell Technologies Inc. The company said Stemedica’s bone marrow-derived, allogeneic MSCs are different from other MSCs because they are grown under hypoxic conditions that closely resemble the environment in which they thrive on in the body.
Dr. Stephen Epstein, CardioCell’s Scientific Advisory Board Chair, said “Although past trials have tested the efficacy of different stem cells in patients with DCM, CardioCell’s itMSCs, grown under chronic hypoxic conditions, are unique. As compared to stem cells grown under normoxic conditions, they express higher levels of factors that could exert beneficial effects on the mechanisms contributing to myocardial dysfunction and disease progression. This study, therefore, provides an exciting opportunity to test the potential of these itMSCs to attenuate or eliminate these mechanisms and, in so doing, improve patient outcomes.”
The trial entitled “A Phase 2a, Single-Blind, Placebo-Controlled, Crossover, Multi-Center, Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-Tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-Ischemic Etiology,” will be conducted at Emory University, Northwestern University, and the University of Pennsylvania in May this year.