Korean deaths spark inquiry

Cases highlight the challenge of policing multinational trade in stem-cell treatments.

RNL Life Science offers patient testimony at its California offices.D. Cyranoski

The controversy over stem-cell tourism, in which patients travel to other countries for unapproved stem-cell treatments, continues to grow. In June, researchers in Thailand reported finding "strange lesions" in a patient who had died following stem-cell therapy for kidney disease (see Nature 465, 997; 2010). And in August, an 18-month-old Romanian boy died after receiving a brain injection of stem cells.

Now South Korea is trying to crack down on the practice. Following the recent deaths of two Koreans who had received injections of stem cells, the Korea Food and Drug Administration and the health ministry last week launched an investigation into companies offering the treatments. But the latest cases highlight the difficulty of policing these therapies or determining their safety, because some companies are setting up operations around the globe, taking advantage of loopholes in other countries' regulations.

One of the companies under scrutiny is Seoul-based RNL Bio, which formulated the cells used to treat the two Korean patients. The firm prepares stem cells at its processing centre in Seoul and sends them to affiliated clinics in China, Japan or elsewhere. Patients travel to these clinics to have the injections, which are illegal in South Korea.

Drug or body part?

In a statement, RNL Bio's chief executive, Ra Jeong-chan, has denied that his company's treatments had anything to do with the deaths. The Korean media are reporting that one patient, a 73-year-old man, died in Japan following a pulmonary embolism; the other failed to wake after receiving an anaesthetic while in China.

Jin Han Hong, president of RNL Life Science, the company's subsidiary in Los Angeles, California, says that the government's investigation will try to determine whether their stem-cell processing in Korea should be banned. "The government wants to define it as a drug and make it illegal," says Hong, who defends the practice: "From our viewpoint it is just part of the patient's body."

Nobuyoshi Tani, head of the regenerative medicine office of the Japanese health ministry's Research and Development Division, says that companies must gain government approval before they can sell stem-cell therapies in Japan. But Japanese doctors don't need approval to import stem cells for use in their practice.

Last year, China passed regulations that would require stem-cell therapies to pass clinical trials, but there has been much debate about how those rules should be implemented. While the gov­ernment puts together guidelines, companies such as RNL Bio face an uncertain regulatory situation.

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