San Diego-based biotech CardioCell announced on Wednesday that it has launched two new clinical trials of its stem cell-based treatment for heart attack patients. The company will run a Phase IIa AMI clinical trial in the U.S. along with a Phase III AMI trial in the Republic of Kazakhstan.
CardioCell’s heart attack treatment is based on ischemic tolerant mesenchymal stem cells or itMSCs, produced by parent company Stemedica Cell Technologies, which is also based in San Diego. According to CardioCell, their stem cells are grown under hypoxic, or oxygen-deprived, conditions that “more closely resemble the environment in which they live in the body.” (CardioCell press release)
Dr. Stephen Epstein, chair of CardioCell’s scientific advisory board, and the director of translational and vascular biology research at the MedStar Heart Institute in Washington, D.C., states that stem cells grown under hypoxic conditions express higher levels of molecules associated with healing and are attracted to injured tissue more robustly than are stem cells grown under normal conditions in the lab.
The two clinical trials being launched will help determine if CardioCell’s treatment can minimize cell death during a heart attack and in the process reduce scar tissue, which can lead to chronic heart failure.
The U.S. trial will be conducted at Emory University in Atlanta Georgia, Sanford Health in North Dakota and the Mercy Gilbert Medical Center near Phoenix, Arizona. The Kazakhstan trial will be conducted by that country’s National Scientific Medical Center and is sponsored by local licensee Altaco XXI.
CardioCell was formed by Stemedica in 2013 and focuses specifically on stem cell-based therapies for cardiac conditions such as acute myocardial infarction (AMI), chronic heart failure (CHF), and peripheral artery disease.