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Stem Cell Treatments in South Korea:

Cartistem & RNL Bio Stem Cell

Deaths

• 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

• 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

• 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.