IN THE NEWSSPRINGHILL GROUP  COUNSELLING      Everything You         Discuss
Stem Cell Treatments in South Korea:   Cartistem & RNL Bio Stem Cell               Deaths• World’s 2nd stem cell drug batc...
• Two South Korean biotechnology firms  expect their stem cell drugs—Cartistem, a  treatment of damaged cartilage produced...
• Medipost’s Cartistem is a drug for treating  degenerative arthritis and knee cartilage  defects.•• “We are currently rev...
• If Cartistem and Anterogen’s anal fistula  treatment medicine get the green light, they  could be available on the marke...
• Last July, South Korea became the world’s  first country to approve a stem cell-based  drug called Hearticellgram-AMI th...
Stem Cell is a Medicine: Korean    Supreme Court Ruling• Are stem cells considered as medicines? If  you are in South Kore...
• According to the Korea Times, the Korean  Supreme Court upheld a lower court’s  decision which ruled in favor of patient...
More from Korea Times:• Justice Min Young-il ruled in favor of 60-  year-old Choi and eight others who filed a  suit again...
• Min said, “Stem cell use is considered a  medicine if it was extracted from the human  body for treatment purposes. The ...
• Moreover, the use of stem cells was still  undergoing debate at the time and the  practice was still in the experimental...
Stem Cell Treatment Safety: Patient Deaths After Stem Cell           Injections• Are stem cell therapies safe? Check out t...
• Questions regarding the safety of stem cell  treatments continue to land in the news.  Earlier, the death of a baby who ...
• Now a biotechnology company in South  Korea, RNL Bio, is at the center of a  controversy following claims that its  pati...
• The company is contesting suggestions that  the two patients died because of the  treatment they received and contends t...
More from the Korea Times:• “There has been no scientific evidence reported here or  elsewhere that stem cell injections c...
• Ra added to the drama by bringing up one  of his clients, who didn’t reveal his name  but spoke emotionally about how th...
• “The 73-year-old patient who died in Japan  was a former surgeon, who had been in a  state of fatigue, probably due to t...
• According to Ra, RNL has so far introduced  around 8,000 of its patients to foreign  clinics that provide stem cell trea...
• Ra claims that RNL has no particular  business connections with the clinics in  Japan and China it has been directing it...
IN THE NEWS - SPRINGHILL GROUP COUNSELLING - Stem Cell Treatments in South Korea
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IN THE NEWS - SPRINGHILL GROUP COUNSELLING - Stem Cell Treatments in South Korea

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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)

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

  1. 1. IN THE NEWSSPRINGHILL GROUP COUNSELLING Everything You Discuss
  2. 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. 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)
  4. 4. • 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.•
  5. 5. • 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.
  6. 6. • 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.
  7. 7. 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.
  8. 8. • 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”.
  9. 9. 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.
  10. 10. • 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.
  11. 11. • 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”.
  12. 12. 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.
  13. 13. • 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.
  14. 14. • 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.
  15. 15. • 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.
  16. 16. 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.
  17. 17. • 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.
  18. 18. • “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.
  19. 19. • 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).
  20. 20. • Ra claims that RNL has no particular business connections with the clinics in Japan and China it has been directing its clients to.

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