SEONGNAM, South Korea (Reuters) - 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.
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.”
However, the research for the medication has not been vetted by independent experts. An FCB-Pharmicell official said the company was currently seeking a “peer review” in a publication.
Oh of the Catholic University said the lack of independent expert scrutiny and insufficient testing of the treatment’s effectiveness were disappointing for what could otherwise be seen as an indisputable breakthrough.
“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 said.
South Korea had once been considered a 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, sparking a fraud case that shook the global scientific community.
A peer review of Hwang’s work was subsequently withdrawn.
While his work on human embryonic stem cells was discredited, Hwang’s team has been vindicated in its work on the world’s first cloned dog, an Afghan hound named Snuppy.
There is still controversy over the role Hwang played in that project, with colleagues saying they developed the technology that resulted in the cloned dog. Snuppy was named Most Amazing Invention of the year by Time magazine in 2005.
Park Youn-joo, director of the advanced-therapy product division at the KFDA regulatory body, told Reuters in an interview that authorities had closely monitored research and development in the latest project which began in 2004.
“We’ve been trying to minimise errors of the development process by actively responding to those developers’ consultation from the early stage for the product development,” Park said.
“Domestic researchers’ outstanding technical skill has played an important role in commercialization of the stem cell medication,” Park added.
FCB-Pharmicell specializes in developing stem cell drugs for incurable diseases. 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.
Shares in FCB Twelve Co, which announced a full takeover of its affiliate FCB-Pharmicell on Monday, rose as much as 85 percent in just a week in late June, buoyed by expectations of the KFDA approval of the treatment. FCB Twelve has a market value of around $271 million.
The stem cell medication, if injected into coronary arteries, will help the damaged cells regenerate and recover function, FCB-Pharmicell says.
In the company’s clinical trials over the past six years, patients showed a near 6 percent improvement in heart function six months after one dose of the injection, it says.
“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,” said Lee Sung-hwan, a professor at the Yonsei University Wonju Christian Hospital.
Oh said the public should not be misled into thinking that the approval of the new treatment will soon lead to cures for as-yet-incurable illnesses.
“This approval means a certification that there are no major problems in terms of safety. What it also means is that the (KFDA) will be watching what the market says about the effectiveness,” Oh said.
“We’re not quite at the stage of picking the fruit of our labor to eat it. The consensus around the world is that we are still very much at the stage of research.”
Additional reporting by Jack Kim and Tan Ee Lyn; Writing by Jeremy Laurence; Editing by John Chalmers