Pharmicell said Monday that it has published a study result reconfirming the therapeutic effects of Cellgram-AMI, an acute myocardial infarction stem cell therapy.
Cellgram-AMI is the world's first stem cell treatment drug that received marketing approval from the Ministry of Food and Drug Safety in 2011. Its main implication is improving the left ventricular ejection fraction.
The company had been running a follow-up clinical study on 26 patients with acute myocardial infarction at the St. Carollo Hospital in Suncheon from January 2012 to May 2015.
“The hospital studied 26 patients who were reperfused within 24 hours after acute myocardial infarction,” Professor Cho Jang-hyun, head researcher for the study, said. “A single-photon emission computed tomography (SPECT) showed that the improvement rate of left ventricular ejection fraction (heart pumping ability) significantly increased in the group treated with Cellgram-AMI (14 patients) compared to the control group (12 patients).”
The company said the study reconfirmed the left ventricular ejection fraction improves without significant side effects in patients treated with Cellgram-AMI.
“Based on a four-year clinical study conducted at a large-scale general hospital, the company has reaffirmed the efficacy and safety of Cellgram-AMI,” Pharmicell CEO Kim Hyun-soo said.
Since its approval in 2011, the drug has been used in the treatment of patients with acute myocardial infarction, Kim noted.
“As we have reaffirmed the efficacy of the treatment, we believe it will become a necessary remedy for patients suffering from heart failure,” he added.
Cardiovascular Drugs and Therapy published the result of the study.