RNL Bio probed over stem cell treatmentsHealth authorities said yesterday that it requested prosecutors to investigate RNL Bio, a Seoul-based biopharmaceutical firm, and its five local partner clinics for manufacturing unauthorized stem cell treatments or administering them to patients.
The move came two months after the Ministry of Health and Welfare, together with the Korea Food and Drug Administration, opened an internal investigation of RNL Bio after allegations at a parliamentary audit that two Koreans had died after receiving stem cell treatments at RNL Bio’s partner clinics overseas.
In Korea, restrictions on producing, selling and administering medicines made of stem cells or ingredients extracted from the process of cultivating stem cells are stringent because of the unconfirmed safety of stem cell treatments.
RNL had been allowed only to conduct a clinical experiment of stem cell medicines on patients who consented to the experiment. The ministry yesterday suspended the company’s clinical experiment for three months.
The Ministry of Health and Welfare said in a statement that its internal investigation concluded that RNL Bio as well as five partner clinics - three in Seoul, one in Gyeonggi and one in South Gyeongsang - violated the pharmaceutical affairs law because they were supposed to provide treatment to the subjects of the clinical experiment for free but actually charged them.
The ministry said RNL Bio extracted adipose-derived stem cells from around 8,000 patients between 2007 and last year, cultivated the stem cells, and requested partner hospitals to administer medicine made from the cultivated cells to the patients. The patients paid 10 million won ($8,921) to 30 million won for the treatments.
Most patients received treatment overseas, but some received them in Korea, the ministry said. The ministry conducted a telephone survey of 50 patients randomly selected from the 8,000. Among the sample group of 50, slightly more than 20 people answered they received treatment in Japan while three said it was done in Korea. The others declined to respond.
RNL Bio drew media attention when Joo Seung-yong, a Democratic Party lawmaker, disclosed in November that two people receiving stem cell treatment overseas on RNL’s “medical tour” service died afterward.
The International Cellular Medicine Society, an international group that acts as a watchdog for adult stem cell therapy, issued a statement on Dec. 13 that said the death of one of the patients, Lim Sang-keun, was likely to have been caused or triggered by the procedure. Lim, 74, died on the same day as the treatment in Japan.
The ministry said it did not investigate the deaths of the two patients.
RNL Bio said it was innocent. “We extracted, cultivated and stored stem cells and were paid for the services only,” said Kim Ju-seon, an RNL executive. “It was the patients who went to the hospitals and got treated, so the treatment has nothing to do with us.”
By Shin Sung-sik, Moon Gwang-lip [firstname.lastname@example.org]
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