IN THE NEWS - SPRINGHILL GROUP COUNSELLING - Stem Cell Treatments in South Korea

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

• Worlds 2nd stem cell drug batch to get
  thumbs-up A new batch of stem cell-based
  medicinesonly the worlds second so faris set
  to be approved this month by South Korean
  authorities.
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• Two South Korean biotechnology firms expect their
  stem cell drugsCartistem, 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)

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• Mediposts Cartistem is a drug for treating
  degenerative arthritis and knee cartilage
  defects.
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• 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.
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• If Cartistem and Anterogens anal fistula
  treatment medicine get the green light, they
  could be available on the market within a month
  or two, according to market watchers.
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• 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.

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• Last July, South Korea became the worlds first
  country to approve a stem cell-based drug called
  Hearticellgram-AMI that is used to treat acute
  myocardial infarction.
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• The drug is produced by FCB-Pharmicell, a company
  based in Seongnam, south of capital city Seoul.

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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.

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• According to the Korea Times, the Korean Supreme
  Court upheld a lower courts decision which ruled
  in favor of patients who underwent stem cell
  transplantation in a Seoul clinic but found no
  improvement.

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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.

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• Min said, Stem cell use is considered a medicine
  if it was extracted from the human body for
  treatment purposes. The clinics transplantation
  without approval from the Korea Food and Drug
  Administration is a violation of the
  Pharmaceuticals Law.

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• Moreover, the use of stem cells was still
  undergoing debate at the time and the practice
  was still in the experimental stage.
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• 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.

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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.

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• 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.

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• 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.

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• 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.
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• 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.

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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.

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• Ra added to the drama by bringing up one of his
  clients, who didnt 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.

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• 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 didnt die there, but in a Korean hospital
  after failing to wake up from anesthesia, so its
  hard to see the cases being related, Ra said.

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• 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).

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• Ra claims that RNL has no particular business
  connections with the clinics in Japan and China
  it has been directing its clients to.