Deaths, Violations Occur in Patient-Paid Regenerative Care

Tokyo, April 3 (Jiji Press)–A series of fatal accidents and violations involving regenerative medicine have occurred in Japan in patient-paid care, including beauty care and cancer treatment, prompting health authorities to review related systems. Regenerative medicine, which uses cells or genes to restore bodily functions lost due to illness or injury, is not only employed in government-approved pharmaceutical and other medical products but is also widely offered as patient-paid medical care in Japan. Patient-paid care involves large medical bills because it is not covered by the country’s public medical insurance system. Yet patient-paid care using regenerative medicine is often provided without adequate verifications of its effects and safety. In Japan, medical institutions can offer regenerative medicine following submission to the health ministry of regenerative medicine provision plans screened by a government-certified committee. At a clinic in Tokyo in August last year, a patient died after sudden deterioration while fat-derived stem cells were being administered. The health ministry issued an improvement order to a facility linked to the clinic. Other clinics in Tokyo have also had fatal cases or violated regulations by using pharmaceutical products not included in their regenerative medicine provision plans. Lack of scientific support is another issue. A study published in 2023 by the National Cancer Center Japan and others found about one-fourth of regenerative medicine classified as carrying medium levels of risk to be inadequate in terms of scientific support. Last month, the Japanese Society for Regenerative Medicine said it will classify treatment in line with the reliability of evidence, expressing concern over regenerative medicine provided in patient-paid care without adequate evidence. “We want to establish guidelines by listening to patient opinions and working in industry-academic-government collaborations,” Koji Nishida, president of the society, said. He showed readiness to compile a draft in the first half of fiscal 2026. Another factor in the background to the series of accidents and violations is lack of public understanding about the system for regenerative medicine. The government does not evaluate the efficacy and safety of treatments with regenerative medicine. Still, regenerative medicine is often viewed as approved by the government because medical institutions’ regenerative medicine provision plans are screened by the government-certified committee. Concerns about such circumstances are shared within an expert panel at the health ministry, and the ministry intends to work to make the system better understood and also to review the law aimed at securing the safety of regenerative medicine with a view to strengthening patient follow-ups and the monitoring of medical institutions. END [Copyright The Jiji Press, Ltd.]