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A peer review of Hwang’s work was subsequently withdrawn.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.

SHARES SOAR ON GROUND-BREAKING TREATMENT

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.”

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By Heejung Jung and Yi Hyun-young

SEONGNAM, South Korea