Regenerative Medicine: How Can Problems with Out-of-Pocket Treatments Be Prevented?

Editorial

16:20 JST, March 23, 2025

Hopes are high for regenerative medicine, which seeks to use the cells of the body to cure patients. However, some regenerative treatments that have not been covered by public health insurance have been of poor quality, causing health problems.

Regenerative medicine is a kind of treatment that repairs tissues and organs damaged by an illness or injury, using methods such as converting cells.

For example, treatments using induced pluripotent stem (iPS) cells are a type of regenerative medicine. University hospitals and research institutes have conducted clinical research on iPS cells with the aim of applying them to the treatment of intractable diseases such as heart and eye conditions.

Meanwhile, treatments using regenerative medicine have been performed on an out-of-pocket basis at private clinics for cosmetic purposes such as wrinkle removal, as well as for treating cancer and other conditions, with practitioners touting the purported effects. Even when scientific evidence of their effectiveness is insufficient, such therapies have been provided at the request of patients and at their own expense, as they are not covered by public health insurance.

The Law on the Safety of Regenerative Medicine, which took effect in 2014, requires all medical institutions that use regenerative medicine to formulate a treatment plan and submit it to the central government. Their plans also must be screened by government-approved committees of experts to ensure the safety of patients and other matters.

In reality, however, problems have continued to arise over regenerative medicine.

Last autumn, two people who had received cell injections to prevent cancer at clinics in Tokyo were taken to the hospital after developing serious infections. An investigation by the Health, Labor and Welfare Ministry found deficiencies in the procedures, including the fact that the treatments were not performed in line with the plans submitted by the clinics.

The National Cancer Center and other entities examined the treatment plans that had been submitted to the central government. The safety of 25% of these plans was found to be questionable.

Even though such treatments are not covered by public health insurance, it will likely be necessary to introduce a system in which government entities will check whether medical institutions formulate appropriate plans and ensure the safety of patients.

The treatment plans examined must have been screened by expert committees in the first place, so these results can be said to indicate laxity in the committees’ checks.

Last year, the government implemented a legal revision that allows it to conduct on-site inspections of committees suspected of not performing appropriate screenings. It should give thorough instructions to such committees.

Last month, the International Society for Stem Cell Research, which mainly consists of doctors from around the world, called for the ministry to strengthen its surveillance of regenerative medicine. The society cited concerns about the safety of patients amid the current situation in which the use of regenerative medicine has expanded through out-of-pocket treatments.

If low-quality treatments that are not covered by public health insurance are left unchecked, that could damage the credibility of Japan’s regenerative medicine as a whole.

Some patients may have high hopes when they see ads using such language as “groundbreaking effects,” but each patient seeking such treatment should bear in mind that the risks associated with new therapies are not remotely small.

(From The Yomiuri Shimbun, March 23, 2025)