July 7, 2011
S Korea Approves Stem Cell Treatment For Heart Attack Victims
Five years after South Korea's scientific reputation was shattered by a cloning research scandal, the country has approved stem cell medication for heart attack victims.
South Korea put stem cell research on hold after Hwang Woo-Suk was found guilty of fraud for his work in the field in 2005.
The Korea Food and Drug Administration (KFDA) approved the sale of the Hearticellgram-AMI treatment, developed by FCB-Pharmicell. This approval demonstrates the new push to put research back in the field.
"This marks the government opening the road for progressive development in stem cell research," Oh Il-hwan, professor of molecular biology at the Catholic University School of Medicine in Seoul, told Reuters.
"It is expected to make it more accommodating for clinical research in this field," said Oh.
The South Korean team is ahead of other stem cell researchers because it has shown the treatment as being good enough to win regulatory approval and make it available for clinical use.
The KFDA said that after six years of clinical trials, it had finalized all procedures needed to permit the sale of Hearticellgram-AMI, a stem cell therapy for acute myocardial infarction.
"This is the first stem-cell medication to be approved for clinical use not only in Korea, but the entire world," Song Jae-mann, president of the Yonsei University Wonju Christian Hospital where trials were conducted, told Reuters.
"We hope this will serve as a catalyst in the advancement of global stem cell research and its application."
Independent experts have still not vetted the medication, but an FCB-Pharmicell official said the company was currently seeking a "peer review" in a publication.
Oh said the lack of independent expert scrutiny and insufficient testing of the treatment's effectiveness were disappointing for what could be seen as a breakthrough medication.
"Whether the government has done everything in its obligations to be transparent with the public, when it comes to the effectiveness of the treatment, there is some disappointment about that," Oh told Reuters.
South Korea was once considered the global leader in human embryonic stem cell research until review boards said in 2005 that the team led by Hwang had manipulated key data in its studies on cloning stem cells.
Park Youn-joo, director of the advanced-therapy product division at the KFDA regulatory body, told Reuters that authorities closely monitored research and development in the latest project which began in 2004.
"We've been trying to minimize errors of the development process by actively responding to those developers' consultation from the early stage for the product development," Park told Reuters.
"Domestic researchers' outstanding technical skill has played an important role in commercialization of the stem cell medication."
Hearticellgram-AMI takes somatic stem cells extracted from the patient's own bone marrow that are then cultured and directly injected into the damaged heart.
"Our first goal is to apply them in patients with illnesses that are not curable through conventional treatment procedures and medications," FCB-Pharmicell Chief Executive Officer Kim Hyun-soo said from the company's headquarters in Seongnam, south of Seoul.
FCB-Pharmicell said that the stem cell medication will help the damage cells regenerate and recover function.
It said patients have shown in the last six years of clinical trials that there has been a near 6 percent improvement in heart function six months after one dose of the injection.
"Although it's still too early to talk about full recovery rate and survival rate, we can talk about hope for more development and improvements in treatment," Lee Sung-hwan, a professor at the Yonsei University Wonju Christian Hospital, told Reuters.