Death of Patient During Stem Cell Treatment in Japan Draws Scrutiny from Health and Financial Authorities

"Unapproved Regenerative Medicine and Cell Manufacturing Violations Subject to Investigation and Sanctions"

"Domestic Medical Practices Including Patient Recruitment and Brokerage Are Subject to Oversight"

Korea-Based Recruitment and Overseas Procedures Highlight Regulatory Limitations

Authorities are closely monitoring additional announcements from Japan’s Ministry of Health, Labour and Welfare following the death of a Korean patient during stem cell treatment in Japan. Regulators are focusing on the possibility that procedures or distribution took place without undergoing safety verification and review processes. If there is any evidence of advanced regenerative medicine procedures or cell distribution occurring in Korea without the required legal review, the authorities will conduct immediate inspections and take action.

Naturecell affiliate Biostar Stem Cell Technology Research Institute held a press briefing at Ginza Clinic in Tokyo, Japan, in 2024 to announce the results of concurrent intravenous and intrathecal autologous adipose stem cell therapy. Director Rajangchan (first from left) and Japanese physician Yoshio Araki (third) attended. Photo by Yonhap News

According to government and parliamentary sources on March 24, the Ministry of Food and Drug Safety outlined this approach in its report, “Future Response Plan Regarding the Death of a Korean Patient at a Japanese Stem Cell Clinic,” which was submitted to the office of Assemblyman Kim Yoon of the Democratic Party, a member of the National Assembly’s Health and Welfare Committee.

The Japanese Ministry of Health, Labour and Welfare is continuing its investigation into the death of a Korean patient in their 60s who received intravenous stem cell treatment at a medical institution in Tokyo earlier this month. The patient underwent the procedure through a stem cell treatment program operated by an affiliate of the Korean biotech company Naturecell. According to the Japanese ministry, the stem cells administered to the patient were produced at cell manufacturing facilities in both Japan and Korea. Naturecell has stated that the incident was due to a fall and is unrelated to the stem cell treatment itself.

This incident has prompted authorities to consider a comprehensive re-examination of all stem cell treatment programs currently operating in Korea. According to the National Assembly Research Service, the Ministry of Food and Drug Safety can inspect whether domestic cell manufacturing facilities are operating within the scope of their permits and adhering to safety management standards. If unapproved advanced regenerative medicine procedures or similar activities are found in Korea, investigations and sanctions are possible. The Ministry of Health and Welfare can also oversee and supervise domestic medical institutions’ tissue collection, patient recruitment, advertising, and brokerage activities based on medical laws and regulations.

An official from the Ministry of Food and Drug Safety explained regarding this incident, “In order to manufacture and use stem cells in Korea, it is necessary to obtain either advanced biopharmaceutical product approval or approval for clinical research in advanced regenerative medicine.” According to the Ministry of Health and Welfare, the company and affiliates operating the stem cell treatment program linked to this fatality have not applied for clinical research approval for advanced regenerative medicine.

Financial regulators are also paying attention to the profit structures of overseas treatment programs. Their view is that if medical programs with potential legal issues are operated through subsidiaries and profits are transferred to a parent company or related parties, such arrangements can become subject to supervision, regardless of legal separation between entities. A Financial Supervisory Service official explained, “Even if independent legal entities separately handle cell manufacturing and the treatment program, if this structure results in financial gain for the parent company or specific related persons, it can fall under our supervisory purview.”

There are also concerns that authorities have limited ability to comprehensively regulate treatment programs where medical practice is conducted overseas. Kim Eunjeong, legislative investigator at the National Assembly Research Service, pointed out, “There is no regulation capable of integrally managing medical tourism regenerative medicine chains that begin in Korea and end abroad,” adding, “It is structurally difficult for domestic authorities to respond systematically to damages that occur outside the country.”

Naturecell, a stem cell specialist company, has operated Japanese stem cell treatment programs via its affiliate’s website, “naturecell.net.” The stem cells administered to patients are developed and manufactured by Naturecell and its affiliates. According to the “Regenerative Medicine Treatment Plan” submitted by the Japanese clinic where the death occurred, three facilities—including the Naturecell Cell Physiology Education & Research Institute and two affiliate-run sites—were listed as stem cell suppliers. Rajangchan, known as the key developer of the core technology used in the stem cell treatments, holds concurrent positions as CEO of an affiliate operating the program and was appointed as CEO of Naturecell on March 20, following the fatal incident, after previously serving as chairman.

Naturecell stated in a public disclosure on March 16, “The Japanese medical institution where the fatality occurred is neither operated by our company nor under contract with us,” and asserted, “This matter is unrelated to our company.” Regarding ongoing stem cell research and development with affiliates, the company added, “This is a separate issue from the operation of regenerative medicine programs in Japan.”

This content was produced with the assistance of AI translation services.