CardioCell Begins Phase 2A Trial Of itMSC In HF
Stemedica Cell Technologies subsidiary CardioCell announced that it has initiated its Phase IIA clinical trial investigating its proprietary ischemia-tolerant mesenchymal stem cells (itMSCs) in patients with chronic heart failure (HF) with non-ischemic cardiomyopathy.
The company’s itMSCs are exclusively licensed from CardioCell’s parent company Stemedica and offer greater homing and engraftment properties than other MSCs. Unlike MSCs grown under normoxic conditions, the bone-marrow-derived itMSCs are grown under hypoxic conditions and secrete higher levels of growth factor associated with healing and neoangionesis.
The U.S.-based single blind, placebo controlled, multi-center, crossover, and randomized Phase IIA trial will investigate the safety and preliminary efficacy of itMSCs in patients with HF of non-ischemic etiology. The study will measure improvements in ejection fraction (EF) and segmental changes in contractility from baseline.
Dr. Sergey Sikora, CardioCell’s president and CEO, said, “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.”
Dr. Javed Butler, director of Heart Failure Research and professor of medicine at Emory University, said that a significant percentage of patients fail to respond to existing drug- and device-based therapies and are at risk for exacerbating HF. At present these patients have no option other than a transplant or a mechanical device implantation. He said, “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.” Dr. Butler is the principal investigator at the trial’s Emory University clinical site.
The CardioCell HF program was developed by Dr. Mihai Gheorghiade, professor of medicine and surgery and director of Experimental Therapeutics at the Center for Cardiovascular Innovation at Northwestern University Feinberg School of Medicine. Dr. Gheorghiade spoke at the recent 4th Annual Lugano Stem Cell Meeting held in Switzerland last month.
The company’s investigational new drug (IND) application for the trial received approval from the U.S. Food and Drug Administration (FDA) earlier this year. Over 20 patients are being enrolled across the trial’s three sites. CardioCell said it expects initial results from the study in early 2015.