Korean Buerger’s disease patients, to receive stem cell therapy in Japan

• An application submitted for approval of therapeutic method in Japan on September 7, using the results of the clinical trial conducted in Korea
• Approval to be granted based on a review by the Committee on Specifically Recognized Regenerative Medicine on September 15

On September 8, the Biostar Stem Cell Research Institute, co-operated by Nature Cell and R Bio, announced that it has completed the application process for acquiring approval of the regenerative medicine treatment method for Buerger’s disease through its medical institution partner in Japan.

In accordance with the Regenerative Medicine Law, enacted on November 25, 2014, the stem cell manufacturers approved by the Ministry of Health, Labour and Welfare (MHLW) will be able to supply stem cells to medical institutions, while the medical institutions, given approval for medical treatment, will be able to administer treatment for designated diseases.

Accordingly, Nishihara Clinic of the Hiromichi Society in Hyogo Prefecture in Japan submitted an application to the Committee on Specifically Recognized Regenerative Medicine for treatment approval, providing a regenerative medicine treatment plan formulated based on the research papers and results of the two-phase clinical trial on VascoStem conducted by Biostar in Korea for treatment of ischemic diseases of the lower extremities such as Buerger’s disease and diabetic foot ulcers.

Upon receiving the approval of the Committee upon review of the treatment plan on September 15, an application will be submitted to MHLW for the final treatment approval. There are a total of 17 committees on Specifically Recognized Regenerative Medicine, and this particular review will be conducted by the Committee on Specifically Recognized Regenerative Medicine, an advanced medicine promotion organization based in Nagoya.

When the treatment plan is approved, R-Japan’s Stem Cell Culture Center, which has already obtained the manufacture approval from the competent authorities, will culture and supply the stem cells necessary for treating Buerger’s disease and diabetic foot ulcer patients from around the world including Korea and Japan.

Biostar plans to establish a broad cooperation network in Japan by forming partnerships with multiple medical institutions in the country, with the aim of providing autologous stem cell therapy to patients suffering from intractable diseases including degenerative arthritis and dementia, regardless of their nationalities.

The Director of the Nishihara Clinic, who completed the application process, said, “There are no adequate therapeutic agents available, even in Japan, and the clinical trial results obtained in Korea in relation to Buerger’s disease, classified as an intractable disease, are considered groundbreaking. As soon as we obtain the necessary approval, we will be able to provide treatment for patients form Korea, China, the U.S. and other parts of the world in Japan.”

Dr. Ra Jeong-chan, the President of the Biostar Stem Cell Research Institute, said, “VascoStem, developed with our own stem cell technology, has been recognized for its safety and efficacy through the clinical trial conducted with patients with severe cases of Buerger’s disease. It brings me great joy to help patients who have been suffering due to the lack of adequate therapeutic agents. I believe that the Ministry of Food and Drug Safety of Korea will designate VascoStem as an orphan drug and grant a conditional approval so as to contribute to the efforts of treating Buerger’s disease and even allow foreign patients to receive treatment in Korea.”

Mr. Jo, aged 51, who participated in the clinical trial on the treatment of Buerger’s disease with VasoStem, lamented the current situation, stating, “The technology was developed and tested in Korea, so why must Korean patients receive the treatment in Japan?”