After six years of clinical trials, the South Korean Food and Drug Administration approved a stem-cell-based treatment for commercial sale last week—making South Korea the first country where a stem cell medication has been green-lighted for clinical use. Developed by FCB-Pharmicell, a Korean biotech that specializes in stem cell drugs, Hearticellgram-AMI consists of an injection of somatic stem cells cultured from the bone marrow into the coronary arteries of patients who have suffered from acute myocardial infarction. According to the company, just one injection is enough to promote a 6 percent improvement in heart function after 6 months. However, there has been concern over a lack of independent validation of the treatment, Reuters reports, as FCB-Pharmicell’s new product is yet to be vetted by a peer review publication.
Backed by two leading medical journals, researchers propose a new plan to publish clinical trial data that pharmaceutical companies often try to bury.