Korea to approve world’s 1st stem cell therapeutic drug

Korea will approve the world’s first stem cell therapeutic drug, the Korea Food and Drug Administration said Friday.

The state-run regulator said Hearticellgram-AMI, a stem cell medication for acute myocardial infarction manufactured by the bio-venture company FCB-Pharmcell, will be approved early next month. This will be the world`s first approval of a medication using adult stem cells.

Stem cells have the ability to be differentiated in body organs such as neurons, blood and cartilage. If injected into the body after proliferation, they find their way to damaged regions to heal them.

Clinical trials on the effectiveness and safety of the groundbreaking drug have been conducted on 40 patients over the past five years. The trial results showed a rise of just 5.93 percent in the heart ejection fraction in the patients, while another 40 patients who did not take the drug saw their fraction rise 1.76 percent.

The heart ejection fraction is the share of blood ejection from the heart`s left ventricle to the left atrium, and is a gauge for the improvement of heart function.

An FCB-Pharmcell source said, “If 100 percent of heart function is considered the basis, a 5-percent increase in the heart ejection fraction means a 5-percent improvement. So this translates into around a 10-percent increase for someone whose heart functions at 50-percent capacity.”

The drug is classified as "ethical" and directly injected to a heart blood vessel. It will be available by prescription as early as September.

As of 2009, 68,021 Koreans suffered from acute myocardial infarction. The drug manufacturer said 3-5 percent of such patients in serious condition will be treated first with the stem cell medication.