Prosecutors on Thursday started an investigation into RNL Bio, which is suspected of illegally formulating stem cells and brokering their overseas injections, the Seoul Central District Prosecutors’ Office said.
The probe, the first of its kind here, came after the Ministry of Health and Welfare filed charges against the company Tuesday, which the ministry said had manufactured stem cells without approval in Korea and connected patients to foreign partner clinics for injections.
“Some of the procedures are believed to have been carried out in domestic hospitals too,” said Lee Dong-wook, director general of healthcare policy at the ministry.
The ministry launched an investigation, along with the Korea Food and Drug Administration, into the company after two people died last year after receiving stem cell injections in Japan and China. A team of international researchers confirmed in December that the two deaths were not directly linked to the procedure.
According to the probe result, some 8,000 patients have received stem cell therapy since 2007 at RNL Bio, with the procedure costs ranging from 10 million won ($9,000) to 30 million won.
It is a legal and common medical procedure for doctors to take stem cells from a patient’s fat tissue or placenta and inject them directly into the patient.
However, to maximize the treatment effect, the amount of stem cells needs to be increased by 20 to 50-fold in the laboratory.
Due to the safety issue, which has not yet been proved globally, the laboratory formulation is only allowed when it is conducted for research purposes along with approval from the drug agency.
Of the 19 medicines under clinical trials, no single case has been finally approved. The situation is the same in other countries.
“RNL Bio has been carrying out clinical trials on three medicines using stem cells. The injections should be offered free of charge to the patients participating in the tests. However, the company also violated a related law by selling the injections to patients,” said Lee.
The prosecution plans to, among other things, decide whether stem cell injections can be considered a treatment that can be conducted without a doctor’s prescription.
Amid fierce controversies, even among academics, they will look into a variety of data including foreign cases.
“Because this is an unprecedented investigation, we should pay greater care in interpreting related laws and legal principles,” said a prosecution official.
However, the company has denied all allegations, hinting at possible legal actions against the ministry.
“We are doing a business formulating stem cells deprived from fat tissue. We don’t do other profit-oriented activities such as injections and brokering an overseas procedure,” said an official from the venture company.
“We will disclose everything clearly to the prosecution.”