The number of South Koreans traveling to Japan for immune cell therapy, which is banned in Korea, has been surging.

Although the treatment costs at least several million won, patients feel they have no choice due to the lack of options in Korea. While countries such as Japan, the United States, and Europe actively foster regenerative medicine industries using stem cells, Korea remains hindered by regulatory restrictions.

According to multiple sources from the medical circle on Monday, about 30,000 Koreans undergo stem cell therapy tourism annually. With each treatment costing 6 million won ($4,284) to 8 million won, nearly 200 billion won flows in Japan yearly. This stands in stark contrast to the trend of global patients seeking medical care in Korea.

Experts attribute this situation to strict regulations implemented after the 2005 Hwang Woo-suk scandal, which limited stem cell research and treatments for nearly 20 years.

However, Korea has been making efforts to ease restrictions. The Advanced Regenerative Bio Act was introduced in 2020, and amendments were passed in the National Assembly in February 2024. The Ministry of Health and Welfare plans to finalize regulations by December 9th, 2024, with implementation set for February 2025.

These changes aim to expand clinical research to cover all diseases and allow patients to receive treatments approved through strict evaluations.

Despite the moves forward, the regulatory changes fall short of meeting patient demand, according to the experts.

“Although the government has made improvements, we have a long road ahead of us to catch up to Japan,” CHA Bio Group Chief Business Officer Yang Eun-young said, at. “Moreover, the treatments are still limited to those with severe, rare, or intractable diseases, leaving most patients traveling to Japan without domestic options.”

At the Tokyo-based Total Cell Clinic run by CHA Bio Group, 30 to 40 percent of Korean patients over the past decade were cancer survivors, 30 percent were arthritis patients suffering from chronic pain, and another 30 percent sought anti-aging or cosmetic benefits. These patients are not classified as severe or intractable cases under current Korean law, so they remain ineligible for treatment domestically.

In Japan, stem cell therapy is considered a medical procedure with minimal regulatory oversight, and Japanese law has permitted unrestricted cell therapy at medical institutions since 2015. Following Professor Shinya Yamanaka’s Nobel Prize win in 2012 for his work on induced pluripotent stem cells, Japan embraced stem cell research as a core focus of future medicine while significantly loosening restrictions.

Treatment costs in Japan range from several million won to over 100 million won. The stem cell therapy market, including related industries, is estimated to be worth trillions of won, with Korean companies operating clinics in Tokyo or partnering with Japanese hospitals.

“Japan treats cell therapies as a medical practice rather than pharmaceuticals, with looser Good Manufacturing Practice (GMP) standards, cutting production costs in half compared to Korea.

However, concerns persist about the safety of unregulated procedures. While most clinics in Japan are run by Korean-verified hospitals, some operate in legal gray areas, risking medical accidents.

“Some companies lure patients with convincing promises and conduct borderline illegal treatments, making it a precarious situation,” a biotech industry insider said.

“Since these treatments often use the patient’s own stem cells, there is no reason to ban them in Korea,” the official said. “It would be better to incorporate them into the regulatory framework so that they are properly regulated.”