Stem Cell Treatments in South Korea: Cartistem & RNL Bio Stem Cell Deaths

http://healthcarenewsblog.com/stem-cell-treatments-in-south-korea-cartistem-rnl-bio-stem-cell-deaths/

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 Ruling04 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 Injections27 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.

Adventures in Parenting Abroad Part 1: Knocked Up

http://thethreewisemonkeys.com/2012/07/12/adventures-in-parenting-abroad-part-1-knocked-up/

I arrived in Korea from my native U.S. at exactly 32 weeks pregnant. I traveled literally the last day my midwife would allow it, not that she’d have much say now that I was going to be approximately 8,300 kms away. We clutched her handwritten note granting me permission to travel as we checked in at Sea-Tac International Airport, in case the airline, upon observing my giant belly, refused to allow me to board for fear that I’d birth my baby reclined in seat 10A.

We had no such issues and, perhaps due to my excessive and neurotic obsession with water-consumption, I was barely even swollen when we touched down 11+ hours later at Incheon. After a day or two of rest and internal clock readjustment, I set out to explore my new home. My first few days wandering around led me to a few possible conclusions about pregnancy in Seoul. I – or more accurately, my belly – was stared at each time I left the apartment and I noticed very few other pregnant women. I thought perhaps a) there really weren’t that many pregnant women (given that South Korea has the lowest birth-rate in the developed world this seemed like a reasonable conclusion), or b) women did not leave the house when they were pregnant (thus the stares).

After a few more days of wandering I discovered that there were in fact quite a few pregnant women around, I just hadn’t been able to see their bellies under the shapeless tent-like maternity get-up they were sporting combined with the very small (by Western standards) size of their pregnant bellies. My pregnant sisters were in fact everywhere, hidden in plain site. Upon realizing how my skills of observation had initially failed me, I decided I needed to do some investigating of what pregnancy in Korea was all about. What follows, for your information and reading pleasure, is what I learned through both experience (read: trial and error), and through hard-hitting and in-depth (read: rude and invasive) questioning.

One thing I was delighted to discover is that Seoul is very pregnant-lady-bladder friendly. This is no small thing because, let’s face it, the way to a pregnant lady’s heart is not only through her stomach, but also through her bladder. Clean and free toilets are abundant. There’s even a really great app that tells you the closest location of a toilet from wherever you are in the city.

Something I was less excited about was the availability and choice of maternity wear. As I mentioned, one of the reasons I wasn’t able to observe many pregnant women initially was because they were all wearing what can only be described as tents. Unlike modern maternity wear in the US which tends to accentuate the growing belly, maternity wear here in Korea seems to be about camouflaging and/or hiding the shape. I asked my doula about this and was told that Koreans do not find the pregnant female form to be very attractive, which is probably why I was getting stared at so intently as I walked around with my big belly proudly displayed. If floral tents and oddly-long oversized sweatshirts aren’t your thing, you can find reasonably priced maternity wear at H & M in Myeong-dong and D-Cube City. They even have nursing tops and bras that are capable of containing your undoubtedly giant pregnant knockers.

The bellies that Korean women are hiding under their billowing maternity tops are, in fact, quite small. Compared to us western gals, Koreans are petite to begin with, but are also encouraged to gain only about 7 kilos (15.4 lbs) during pregnancy. That’s total, not per trimester, ladies. Caregivers here tell pregnant women that gaining much more will lead to a difficult labour. Contrast this with the US where regular weight gain can be anywhere from 9 to 19 kilos (approximately 20 to 40 lbs) and sometimes even more. At my last appointment with my midwife in the States, I had gained approximately 7 kilos and was told to eat more. By the time I got here and had my first appointment with my caregiver, I had gained about 8 kilos and was told to eat less. It is my belief that this emphasis on minimal weight gain is driven both by a (misguided) belief that smaller babies are easier to birth combined with the Korean obsession with physical appearance and a desire to quickly lose the baby weight. The less you gain, the less you have to lose, and the sooner you can be seen as “attractive” once again.