World’s 2nd stem cell drug batch to get thumbs-up: A new batch of stem cell-based medicines—only the world’s second so far—is set to be approved this month by South Korean authorities.
Two South Korean biotechnology firms expect their stem cell drugs—Cartistem, a treatment of damaged cartilage produced by Medipost Inc. and a stem cell-based anal fistula drug by Anterogen Co.— to be approved by the Korea Food and Drug Administration (KFDA)
Medipost’s Cartistem is a drug for treating degenerative arthritis and knee cartilage defects.
“We are currently reviewing documents additionally submitted by each company. Permission will be issued sooner or later,” a KFDA official said on condition of anonymity.
If Cartistem and Anterogen’s anal fistula treatment medicine get the green light, they could be available on the market within a month or two, according to market watchers.
According to experts, because the drugs do not use analogous stem cells from patients, these can be mass-produced and its quality can be maintained better but stem cells from other people.
Last July, South Korea became the world’s first country to approve a stem cell-based drug called Hearticellgram-AMI that is used to treat acute myocardial infarction.
The drug is produced by FCB-Pharmicell, a company based in Seongnam, south of capital city Seoul.
Stem Cell is a Medicine: Korean Supreme Court Ruling
04 November 2010
Are stem cells considered as medicines? If you are in South Korea, the answer — according to a recent Supreme Court decision — is “Yes”. Hence, stem cell therapies must require approval from the Korea Food and Drug Administration before they are administered on patients.
According to the Korea Times, the Korean Supreme Court upheld a lower court’s decision which ruled in favor of patients who underwent stem cell transplantation in a Seoul clinic but “found no improvement”.
More from Korea Times:
Justice Min Young-il ruled in favor of 60-year-old Choi and eight others who filed a suit against Kim, an operator of a clinic in Seoul, because the stem cell transplantations they had received were not as effective as they were told they would be.
Min said, “Stem cell use is considered a medicine if it was extracted from the human body for treatment purposes. The clinic’s transplantation without approval from the Korea Food and Drug Administration is a violation of the Pharmaceuticals Law.
Moreover, the use of stem cells was still undergoing debate at the time and the practice was still in the experimental stage.”
The clinic was ordered to pay anywhere between 16 and 30 million won to each of the nine plaintiffs for “having failed to fully explain the risks associated with the practice and for providing uncertain information about the much-hyped treatment”.
Stem Cell Treatment Safety: Patient Deaths After Stem Cell Injections
27 October 2010
Are stem cell therapies safe? Check out the story below about safety concerns surrounding RNL Bio, a South Korean biotechnology firm, and the death of its patients following stem cell treatments in China and Japan.
Questions regarding the safety of stem cell treatments continue to land in the news. Earlier, the death of a baby who underwent therapy at the Xcell Stem Cell Center in Germany became the subject of news stories by The Daily Telegraph.
Now a biotechnology company in South Korea, RNL Bio, is at the center of a controversy following claims that its patients died following stem cell treatments in Japan and China. The stem cell treatment is not approved by health authorities in South Korea so RNL Bio directs its patients to other countries.
The company is contesting suggestions that the two patients died because of the treatment they received and contends that the deaths and the therapy they received are not related at all.
Another patient is claiming that he developed cancer on his neck just weeks after he had stem cell injections in China. RNL Bio CEO Ra Jeong-chan also disputes this claim.
More from the Korea Times:
“There has been no scientific evidence reported here or elsewhere that stem cell injections can be the cause of cancer or cardiovascular disease. In fact our studies with the Seoul National University (SNU) suggest that stem cell injections rather help suppress such conditions,’’ Ra said at a Seoul news conference, which had a circus atmosphere as RNL employees tussled with a group of five or six people, claiming themselves to be victims of faulty stem cell treatments, who attempted to enter the conference room.
Ra added to the drama by bringing up one of his clients, who didn’t reveal his name but spoke emotionally about how the stem cell treatment he received in China saved him from having to have his foot amputated, which was severely damaged due to a diabetes-related infection.
“The 73-year-old patient who died in Japan was a former surgeon, who had been in a state of fatigue, probably due to the flight, and failed to inform Japanese doctors that he previously had heart surgery before the stem cell injections. The patient who received stem cell treatments in China didn’t die there, but in a Korean hospital after failing to wake up from anesthesia, so it’s hard to see the cases being related,’’ Ra said.
According to Ra, RNL has so far introduced around 8,000 of its patients to foreign clinics that provide stem cell treatments. The company is currently conducting a trial of treatment methods for difficult conditions, such as spinal cord injuries and Buerger disease, but has yet to gain approval from the Korea Food and Drug Administration (KFDA).
Ra claims that RNL has no particular business connections with the clinics in Japan and China it has been directing its clients to.