Investigation opens over stem cell treatments

By Kim Tae-jong

The prosecution said Thursday it had launched an investigation into allegations that RNL Bio, a biotechnology firm, and five of its partner clinics have been engaged in the illegal manufacturing of stem cell treatments and administering them to patients.

RNL, a Kosdaq-listed Seoul-based firm known for its expertise in stem cell research and commercial animal cloning, has long been under suspicion of profiting from manufacturing unauthorized treatments using stem cells.

The investigation came following a complaint filed by the Ministry of Health and Welfare, which reviewed the company’s practices in cooperation with the Korea Food and Drug Administration (KFDA).

The prosecution plans to determine whether stem cell treatments are in the category of medicines defined by the authorities before taking any legal action. Any company seeking to sell medication must receive approval from the KFDA after conducting clinical trials.

The health authorities discovered that the company offered stem cell treatments to about 8,000 patients over a period of three years without approval from the authorities, charging 10 million ($9,000) to 30 million won depending on the therapy.

The company extracted patient-specific stem cells from the adult cells of its customers, and introduced them to clinics in China and Japan for treatment, which was dubbed “stem cell tourism.”

Additionally, the firm has allegedly sold stem cell treatments to five local clinics that have administered them to patients.

The main charges against the firm include the production and sales of unlicensed medication, in violation of the Pharmaceutical Law.

Suspicions of the firm’s unlawful business practices first rose in 2008 after the deaths of two patients after receiving an injection of stem cell treatments at clinics in China and Japan.

Another patient also claimed he was diagnosed with cancer in his neck after receiving injections at a different Chinese clinic.