Hwang Woo-suk “is a South Korean veterinarian and researcher. He was a professor of theriogenology and biotechnology at Seoul National University (dismissed on March 20, 2006) who became infamous for fabricating a series of experiments, which appeared in high-profile journals, in the field of stem cell research. Until November 2005, he was considered one of the pioneering experts in the field, best known for two articles published in the journal Science in 2004 and 2005 where he reported to have succeeded in creating human embryonic stem cells by cloning”.
Now the S. Korean government has introduced new regulations and is pumping more money into stem-cell research in an effort to rebuild the pre-eminent position that the country once had. The potential for financial benefits for the technology leaders in stem-cell based medical treatment is enormous and the government is responding to pressure from the country’s health care industry. The government sees potential for revenues for the country from stem-cell based treatments equalling or surpassing even that from its IT industry.
FCB-Pharmicell is a leading Korean company trying to use stem-cell based techniques for medical treatments and in July their Hearticellgram-AMI treatment was approved by the Korean Food and Drug Administration for the clinical treatment of heart-attack victims.
InvestorStemCell: 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. …. 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. ….
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.
Now the government is taking regulatory action to strengthen the oversight provisions but also to simplify licencing. The objective is to try and regain the reputation and credibility of the S. Korean researchers and the companies poised to commercialise the new techniques:
Reuters: South Korea’s president vowed on Monday a series of regulatory reforms to help regain its place as a stem cell research powerhouse, trying to reclaim momentum five years after a cloning scandal. President Lee Myung-bak said that by breathing new life into the industry, it could become “core new growth engine” for Asia’s fourth biggest economy along the same lines as its lucrative IT sector.
“Just a decade ago, Korea took the lead in stem cell research in the world along with the United States,” Lee said in a bi-weekly radio address. “Unfortunately, there was a disappointing incident, which caused inevitable damage to the entire stem-cell research community in Korea,” Lee said, referring to the scandal involving the pre-eminent scientist, Hwang Woo-suk. … As a result of the scandal, South Korea all but put stem cell research into the deep freeze. Lee said the lapse had allowed other countries such as the United States, Japan, Britain and China to get the jump on South Korea, depriving the country of valuable revenue. “While we were faltering in our quest for stem cell research, other nations streamlined their regulations and aggressively expanded their investments in research,” he said.
Lee said the government would invest nearly 100 billion won ($90 million) in stem cell research next year and that it would reform related regulations to make clinical and licensing procedures easier. He said the reforms would help the Korea Food and Drug Administration (KFDA) and other agencies “to ensure that they proactively adapt to the changes in the international environment”.
“The government has decided to foster the stem cell industry as a core new growth engine following the footsteps of the IT industry,” he said.
The k2p blog 