November 28, 2020

The Niche

Knoepfler lab stem cell blog

More new trouble for RNL Bio: Korea reportedly weighs criminal charges over stem cell treatments

RNL Bio has been accused of allegedly smuggling stem cells out of Korea to treat patients in Japan and China without going through customs.

But there is more trouble.

RNL Bio faces additional challenges as reportedly (AsiaOne News) the Korean Government is weighing whether to charge RNL criminally based on their stem cell treatments being illegal even if given abroad. The story is also reported in a different article in the Chosunilbo.

Reportedly, RNL treated more than 15,000 patients in Japan and China (mostly the latter) potentially in violation of Korean law. According to AsiaOne News:

“Due to the safety issue, which has not yet been proven globally, the laboratory formulation is only allowed when it is conducted for research purposes along with approval from the drug agency. Violators are subjected to up to five years in jail or a fine of up to 20 million won.

“We have to look into facts, but it is clearly a violation of Korean drug law if (the company) cultured stem cells without approval in Korea and injected them into patients,” an official at the ministry said.”

The case seems to hinge on whether RNL Bio manufactured the stem cells in Korea or not. The ministry official said in this regard:

“”But if the stem cells were manufactured and injected overseas, it would be hard to apply a local law to the case,” he added.”

According to Chosunilbo:

“The Mainichi Shimbun on Saturday said a hospital in Fukuoka administers stem cell treatments to around 500 Korean patients a month. It said the Hakata branch of Shinjuku Clinic, which opened in May as an ostensible dermatology clinic, is injecting stem cells cultured and stored by RNL Bio, a Seoul-based biotech venture.”

RNL Bio is of course innocent of any and all charges unless proven otherwise, but this is certainly bad PR at the very least.