South Korean biotechnology firms Medipost and Anterogen are set to receive approvals for their stem cell drugs, Cartistem and a treatment for anal fistulas, respectively, marking the world's second stem cell drug batch. A Korean Supreme Court ruling affirms that stem cell therapies are considered medicines, necessitating approval from the Korea Food and Drug Administration prior to patient administration. Additionally, RNL Bio faces scrutiny over patient deaths linked to its stem cell treatments conducted in other countries, with the company disputing claims that the treatments were the cause.

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2. 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.
•

3. • 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)

5. • 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.
•

6. • 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.

7. • 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.

8. 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.

9. • 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”.

10. 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.

11. • 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.

12. • 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”.

13. 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.

14. • 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.

15. • 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.

16. • 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.

17. 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.

18. • 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.

19. • “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.

20. • 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).

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