Posted March. 13, 2005 22:50,
Koreas first clinical demonstration will be carried out to commercialize a stem-cell remedy, which is considered a hope for curing various incurable diseases and cancers.
On March 13, the Korea Food & Drug Administration (KFDA) revealed its plan, saying, Recently, the Ajou University Hospital and FCD-Pharmacell, a bioventure company, handed in a report on its Project to Conduct Clinical Demonstrations to Commercialize A Stem-cell Remedy for Cerebral Infarction, and we will authorize the project without delay.
So far, there have been a few clinical demonstrations of stem-cell treatments for research purposes. But, the upcoming clinical study is the first one for commercial purposes, which means the development of a new medicine.
Even with highly positive results from academic clinical experiments, developers are required to go though commercial clinical demonstrations to put out new drugs.
After being selected as a government project last year, the Ajou Universitys experiment has already gone through demonstrations for research purposes. An official in the KFDA said, The aim is not to judge the medical validity of the remedy, but to make sure that it is fully qualified to hit the market.
Consequently, the first-ever stem-cell drug in Korea is expected to come to the market in 2007 when all the clinical procedures are over.
How The New Drug Works Against Cerebral Infarction
First, 10cc of the patients marrow has to be extracted from the pelvis. In the extracted marrow, there are two to three stem cells on average. Then those cells are cultured for three to four weeks to obtain as many as one trillion stem cells.
Second, the cultured cells are injected into the patients vein. The injected stem cells travel to the damaged parts in the brain and differentiate into cerebral cells. If the differentiation is successful, damaged brain cells will revive and all the complications of the infarction, such as half-body paralysis, will go away.
The demonstration of the drug on animals was successful. From 2003 on, researchers purposefully have had 400 animals afflicted by cerebral infarction and given them shots of human stem cells. As a result, the brain cells and nerves of all the mice came back to life. Not a single mouse died of cerebral infarction.
The clinical experiments performed for research on people did not show side effects, either. The coming demonstration will be comparing 16 cerebral infarction patients with 34 health subjects.
Intense Competition for Being the Worlds First
If the clinical trial is successful, the new drug will be introduced in the second half of 2007. Still, the faster introduction of the medical product in the first half of 2007 is possible because, in much of the related research, significant progress has been made.
On the matter, a KFDA insider added, The results from the experiments on animals and scholastic studies are so good that it might be possible for the new drug to hit the market in a year and half.
At present, searches for stem-cell treatments are active the world over. However, no medication has been commercialized.
But in January 2005, Osiris Therapeutic, an American bio-pharmaceutical company, began clinical demonstrations of a stem-cell drug for Graft-versus-Host-Disease (GVHD). GVHD is a complication that can occur to marrow recipients. The company, too, aims to launch its product in 2007.
Nevertheless, FCD-Pharmacell stressed that its drug is more likely to be the worlds first stem-cell cure. In America, with authorities permission, pharmaceuticals can fast-track their procedures in order to advance the development. A shortcoming of the method is that they often gain insufficient amounts of data.