Marking a first for the California Institute for Regenerative Medicine, the FDA has given the go-ahead for clinical trials on a stem-cell based approach to repairing damage caused by heart attack. CIRM provided funding to the Cedars-Sinai Heart Institute researchers who worked on the potential therapy; as noted in a press release, “this is the first time that research by a CIRM-funded Disease Team has resulted in an Investigational New Drug (IND) approval from the FDA.” More from the release:
The therapy, which will be taken forward by Los Angeles-based biotechnology company Capricor, uses Cardiosphere Derived Cells (CDCs) to reduce scarring and repair the damage caused to heart muscle by a heart attack. The cells are found in heart tissue and have the potential to change into a variety of different heart cell types. The CIRM funded work enabled development of an “off the shelf” product that has the potential to treat large numbers of patients and be available whenever a patient needs it. The theory is that these cells will help support the heart’s own healing mechanisms.
In preliminary studies with a related product derived from the patient’s own cells (e.g., not an “off the shelf” product), giving patients these modified CDCs were shown by an imaging study to reduce the amount of scarring left by the heart attack.