CardioCell LLC, a Stemedica Cell Technologies Inc. subsidiary that creates allogeneic stem-cell therapies for cardiovascular indications, started its Phase 2a clinical trial for chronic heart failure (HF) patients with non-ischemic cardiomyopathy. This trial is the first launch in CardioCell’s HF program that was designed by the company’s Scientific Advisory Board Member Dr. Mihai Gheorghiade. With his support, Principal Investigator Dr. Javed Butler designed this “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,” taking place in the United States.
“CardioCell consulted the world’s leading cardiologists to accelerate our vision for creating breakthrough, allogeneic stem-cell therapies to help patients suffering from chronic HF,” said Dr. Sergey Sikora, CardioCell’s president and CEO. “CardioCell’s Phase 2a clinical trial uses our unique, hypoxically grown stem cells to address non-ischemic cardiomyopathy, a complex condition in which patients have living cardiomyocytes that are not contracting as they should. We hope our itMSCs will assist in reactivating these cardiomyocytes that could, eventually, restore heart function.”
“I joined CardioCell’s Scientific Advisory Board because the company’s therapies hold promise in the field of chronic HF,” said Gheorghiade, professor of medicine and surgery and director of Experimental Therapeutics at the Center for Cardiovascular Innovation at Northwestern University Feinberg School of Medicine. “It’s exciting to see this Phase 2a study– the first CardioCell initiative with which I’ve been involved– launch today.” Dr. Gheorghiade was a featured speaker at the 4th Annual Lugano Stem Cell Meeting in Switzerland June 23 to 24, where he spoke about the potential role of stem-cell therapy in the management of chronic HF.
“Approximately 35% of CHF patients suffer from abnormal heart function not related to coronary artery disease,” said Butler, director of Heart Failure Research and professor of medicine at Emory University. “Some patients respond to standard drug- and device-based therapies, but many others do not. Those patients are at risk for worsening HF, and there are currently no options except a transplant or left-ventricular-assist device implantation for them. We designed this protocol based on CardioCell’s itMSC therapy to test if itMSC treatment via intravenous injection can show efficacy in these patients with non-ischemic cardiomyopathy.”
More than 20 patients are currently being recruited at the study’s three sites– Emory University, which is supervised by Butler; Northwestern University, which is overseen by Principal Investigators Dr. Allen Anderson and Dr. Jane Wilcox; and the University of Pennsylvania, which is led by Principal Investigator Dr. Kenneth Margulies.
The study divides half of the patients into a treatment group and the other half into a control group. CardioCell’s treatment and the placebo are administered intravenously. Progress will be tracked at the baseline, at 90 days and at 180 days and will be measured by MRI to observe improvements in ejection fraction (EF) and segmental changes in contractility. At 90 days after the first injection, the control group will receive CardioCell’s treatment, and the previous treatment group will become the control group receiving saline solution. The endpoint includes EF measurements every three months to observe signs of efficacy via increase in EF. The MRI images will be analyzed in the laboratory of Dr. Raymond Kim, professor of medicine and radiology at Duke University Medical Center and founder and co-director of the Duke Cardiovascular Magnetic Resonance Center. Initial results are expected in early 2015.
Only CardioCell’s 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.
Date: July 8, 2014