Korean Patient Dies at Japanese Stem Cell Clinic Affiliated with Naturecell

Korean Woman in Her 60s Dies During Treatment
at Naturecell's Partner Clinic in Japan
Japanese Health Ministry Issues Emergency Suspension Order

A South Korean patient receiving stem cell treatment in Japan has died, prompting the Japanese government to issue an emergency suspension order to the medical institution involved. The facility that received the suspension order is a partner institution operating the "Japan Stem Cell Therapy Program" run by Naturecell, which the South Korean government recently flagged as potentially illegal.

According to domestic and international medical circles and relevant authorities on March 14, the Japanese Ministry of Health, Labour and Welfare announced the previous day that it had issued an emergency temporary suspension order for regenerative medicine treatment to "Neopolis Clinic Ginza," a medical corporation located in Chuo-ku, Tokyo, based on the Act on Securing Quality, Efficacy and Safety of Regenerative Medicine. The Ministry posted the notice on its official website.

This clinic administered an intravenous injection of stem cells, cultured from the patient's own adipose tissue, to a South Korean woman in her 60s who traveled to Japan on March 10 for chronic pain "medical tourism" involving stem cell therapy. During the procedure, the patient's condition deteriorated rapidly, and she went into cardiac arrest while being transported by ambulance. Although she was transferred to a hospital, she ultimately died. The exact cause of death has not yet been determined, and the Ministry of Health, Labour and Welfare is conducting an on-site investigation to determine the cause. This is the second time the Ministry has issued an emergency suspension order in response to a fatal accident related to regenerative medicine, following a similar incident at a different clinic in Tokyo in August last year.

Exterior view of "Ginza Clinic" located in Tokyo, Japan. Screenshot from the JASC website

The Ministry of Health, Labour and Welfare stated that the cell products used in this treatment were manufactured at both the "JASC Kyoto Stem Cell Cultivation Center" in Kyoto, Japan, and the "Albiot Stem Cell Cultivation Center" in South Korea. The Ministry ordered the suspension of manufacturing at the Kyoto facility and requested that the South Korean facility stop supplying cells to Japan.

Naturecell released a statement on the Biostar Stem Cell Technology Research Institute website, explaining, "The patient suffered a severe fall while in transit, resulting in a cervical spine fracture and other injuries, which ultimately led to her death. There were no issues with the cells or related products, and this will be confirmed through the Ministry's investigation."

Rhee Jeongchan, Chairman of Naturecell and Director of the Biostar Stem Cell Technology Research Institute, sent a message to employees on this day, stating, "On March 11, a client received a 150 million cell intravenous stem cell injection at Ginza Clinic. An autopsy confirmed a cervical spine fracture, but since results from blood tests and other examinations are not yet available, the exact cause of death has not been confirmed." He added, "Upon hearing the urgent news, I assisted the patient's family, who traveled from Korea to Japan, throughout the process."

Chairman Rhee also explained that the stem cells used in this treatment had "passed the initial quality test in Korea, and the final product quality test at JASC in Japan showed no issues either."

Naturecell operates regenerative medicine programs spanning Korea and Japan through its affiliates. The Biostar Stem Cell Technology Research Institute, located in Yeouido, Seoul, develops the stem cell technologies used in the program. Stem cells cultured at Albiot, another affiliate based in Geumcheon-gu, Seoul, and at JASC in Japan are used for patient treatments at partner medical institutions, including Ginza Clinic in Japan.

Last month, the Ministry of Health and Welfare, in response to an inquiry from Assemblyman Kim Yoon's office (Democratic Party of Korea) of the National Assembly's Health and Welfare Committee regarding the "Naturecell overseas stem cell therapy program for domestic patients," stated that there may be potential violations of the Medical Service Act. The Ministry explained, "It appears that adipose tissue collection is conducted by domestic medical institutions at the recruitment and collection stages in Korea. If there are actions such as offering money to refer, broker, or solicit patients to specific domestic medical institutions, or providing a percentage of the treatment fee as a commission for sending patients to specific institutions, these could constitute significant disruptions to the medical service market and may violate Article 27, Paragraph 3 of the Medical Service Act." Even if the procedure is performed in Japan, if related activities such as patient recruitment, consultation, reservation, and tissue collection occur in Korea, the relevant laws could apply.

Promotional material for the "2025 Biostar Cancer and Regeneration Special Project" promoted by Biostar Stem Cell Technology Research Institute, an affiliate of Naturecell. The promotional material explains that cell separation and cultivation take place at a cultivation center in Japan. According to the Japanese Ministry of Health, Labour and Welfare, the cell products used in the treatment of the recently deceased patient were also cultivated at Albiot, a Naturecell affiliate located in Geumcheon-gu, Seoul. Screenshot from the Biostar Stem Cell Technology Research Institute website.

Depending on the results of the Ministry's investigation, there could arise additional legal issues, such as potential violations of the Advanced Regenerative Bio Act. Promotional materials for the "2025 Biostar Cancer and Regeneration Special Project," promoted by the Biostar Stem Cell Technology Research Institute, explain that cell separation and cultivation are performed at a cultivation center in Japan. However, the Ministry of Health, Labour and Welfare announced that some of the cells used in the recent stem cell treatment were confirmed to have been produced at a Korean facility.

If the Ministry of Health, Labour and Welfare's announcement regarding this incident is accurate, it would mean that Biostar's promotional claims differ from the facts, and there is a high possibility that activities in violation of Korean law may have occurred. The Ministry of Health and Welfare had previously stated in its legal interpretation that "the stem cell cultivation process may constitute the manufacture of pharmaceuticals or advanced regenerative medicine," indicating that if stem cell cultivation occurred in Korea, it could be subject to the Advanced Regenerative Bio Act, the Pharmaceutical Affairs Act, and related laws.

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