The Korea Food and Drug Administration (KFDA) has approved the sale of Hearticellgram-AMI, a stem cell therapy for acute myocardial infarction, commonly known as heart attack, which was derived from experimentation with donated adult stem cells.
“This is the first stem-cell medication to be approved for clinical use not only in Korea, but the entire world,” said Song Jae-mann, president of the Yonsei University Wonju Christian Hospital where medical trials were conducted. “We hope this will serve as a catalyst in the advancement of global stem cell research and its application.”
It took six years of clinical trials before the KFDA said it had finalized all procedures needed to permit the sale of the new therapy.
“This marks the government opening the road for progressive development in stem cell research,” said Oh Il-hwan, professor of molecular biology at the Catholic University School of Medicine in Seoul. “It is expected to make it more accommodating for clinical research in this field.”
The developers of the new treatment, FCB-Pharmicell, say that when the medication is injected into the coronary arteries after a heart attack, it will help damaged cells regenerate and recover function.
Clinical trials over the past six years showed a near 6% improvement in patients’ heart function six months after one dose of the injection.
Research for the new therapy still needs to be verified by outside independent experts in the field.
While advocates for embryonic stem cell research (ESCR) often claim that ESCR miracle cures are just around the corner, despite the objections of ethicists and scientists, embryonic stem cell research has yet to produce any significant medical results, and has not led to a single cure. The use of adult stem cells, on the other hand, has already produced many great results in improving health and medicine – without the destruction of human life to obtain the cells.