South Korea back in stem cell spotlight with new treatment

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More than five years after South Korea’s scientific reputation was shattered by a cloning research scandal, the country has approved stem cell medication in the form of a treatment for heart attack victims for the world’s first clinical use.

South Korea all but put stem cell research into the deep freeze after a pre-eminent scientist, Hwang Woo-suk, was found guilty of fraud for his work in the field in 2005.

The state Korea Food and Drug Administration’s (KFDA) approval for the sale of the Hearticellgram-AMI treatment, developed by FCB-Pharmicell, from July 1 signals an ambitious new push to put research in the field back on the frontline.

"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,” said Oh, who previously sat on KFDA panels overseeing stem cell research.

Stem cells are the body’s master cells and the source of all cells and tissues. Because of their ability to generate different types of cells and multiply and self-renew, scientists hope to harness them to treat a variety of diseases and disorders, including cancer and diabetes, and injuries.

Unlike embryonic stem cells, the use of somatic—or adult—stem cells, as in this case, is not controversial as they are derived from adult tissue samples and not destroyed human embryos.

The use of somatic stem cells in treatment is not unprecedented for patients who do not respond to conventional therapy. Countries such as the United States and Germany are using this radical form of treatment in a ‘research’ capacity.

What puts the South Korean team ahead is that it has shown the treatment as being good enough to win regulatory approval and make it available for clinical use.

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After six years of clinical trials, the KFDA said it had finalized all procedures needed to permit the sale of Hearticellgram-AMI, a stem cell therapy for acute myocardial infarction, commonly known as heart attack.

“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 trials were conducted.

“We hope this will serve as a catalyst in the advancement of global stem cell research and its application.”

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