Two hospitals ordered to stop stem cell treatment

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Two hospitals ordered to stop stem cell treatment

Two hospitals authorized to implement a clinical experiment using stem cell treatment developed by RNL Bio were suspended from doing the experiment for three months due to violating required procedures, JoongAng Ilbo learned on Wednesday.

The measure was taken on Tuesday, the same day that health authorities suspended RNL Bio’s clinical experiment for three months and asked prosecutors to investigate the Seoul-based biopharmaceutical company for allegedly selling unapproved stem cell medicine.

The Korea Food and Drug Administration said it suspended Seoul-based Asan Medical Center and Busan-based Pusan National University Hospital from doing an experiment using RNL Bio’s stem cell medicine because they received consent from representatives of the patients participating in the experiment, not from the patients themselves, as is required by the pharmaceutical affairs law.

The KFDA also said that Pusan National University Hospital and Anyang-based Sam Medical Center were given a warning for not implementing the experiment in the way that they said they would do in plans they submitted.

On Tuesday, the KFDA and the Ministry of Health and Welfare said RNL Bio sold unauthorized stem cell medicine to about 8,000 patients through its partner clinics overseas at 10 million won ($8,873) to 30 million won for each patient.

An allegation raised at a parliamentary audit in November that two Koreans died after receiving stem cell treatments at RNL Bio’s partner clinics overseas sparked the health authorities’ investigation.

The company yesterday issued a statement on its Web site denying that it was involved in a benefit-seeking activity. The company said it will cooperate with prosecutors.

By Shin Sung-sik, Moon Gwang-lip []
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