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What is OK-432 therapy?

Now I would like to explain the details of the OK-432 therapy, using the slides. About 75% of patients are diagnosed by the age of two. Another 5% are diagnosed in later years. It is not uncommon for one to be diagnosed during adulthood. I personally have treated a few patients around the age of fifty.

Lymphatic malformations commonly appear in the cervical region, followed by the axillary region, buccal region, and thoracic wall. Concerning types, the macrocystic type is common in the neck, whereas the cavernous type is common on the tongue and cheek. It is very difficult, in fact, impossible to preserve the nerves and blood vessels running through the lymphatic malformations untouched when excising the lymphatic malformations.

Complications after a surgical procedure have been reported: damage to vital structures such as nerves and blood vessels, dysfunction, recurrence, and cosmetic problems. Another surgery is very difficult. OK-432 is a medicine to treat cancers by its immune system stimulating activity. OK-432 is normally injected into the skin, and it is widely known that it causes inflammation of the skin where the shot was made. However, it is also well known that this inflammation does not leave marks on the skin.

Spontaneous resolution occurs. However, it has been rarely expected to happen. Therefore, treatment was attempted to cause inflammation on the lymphatic malformations. However, this was also unsuccessful.

Dr. Tsuto, my colleague at the Children’s Research Hospital, and I discussed the use of OK-432 for the treatment of lymphatic malformations and we decided to make a trial treatment after various preparations. Our first patient was a child of an acquaintance. In four months following treatment, the lymphatic malformations on the right shoulder completely regressed. The skin became normal looking as well without any cosmetic problem.

My first patient from overseas was a boy from the Netherlands. He had difficulty in breathing from the moment of birth due to the lymphatic malformations. The lymphatic malformations ran from his chin to the cervical area. The lymphatic malformations also ran through the trachea and blocked the respiratory tract. The lymphatic malformations in the trachea were treated in the Netherlands. However, breathing did not become easier, and tracheotomy became necessary. In addition, this posed a high risk due to the heaviness of the lymphatic malformations. To secure respiration, a tube was inserted into the respiratory tract from the nose. Another tube was inserted to send nutrients to the body.

This child was unable to leave ICU for seven months following birth. His medication fees were the highest among child patients in the Netherlands. The insurance company in the Netherlands would like him to be treated in Japan if the treatment in Japan could help him. He was sent to Kyoto for treatment, with all the expenses borne by the insurance company.

After seven to ten days following the treatment, there was a time of danger. In this therapy, there is a period when the lymphatic malformation becomes more swollen than the time prior to therapy. The lymphatic malformation of this child became swollen as well. Respiration was secured after pushing the respiration tube by 5 mm further into his tract. Dr. Deguchi, who was responsible for him, was on duty at that night and I left the hospital once. Heading home, I went to Kawaramachi Station of Hankyu Line, but turned back to the hospital and stayed there for the night.

A few months later, his photos were sent to me from the hospital in the Netherlands, showing his skin with noticeable regression in the size of the lymphatic malformation. The hospital also informed me that the operation on the respiratory tract was successful and that he was safely able to come out of ICU to his home.

In this July when I was invited to make a presentation at Nijmegen University in the Netherlands, I could reunite with the boy. He had grown up and was able to move and play like a normal child. However, because a tube touched his vocal cords for a long time, his larynx did not function properly.

OK-432 is not approved in the U.S. Dr. Smith, Pediatric Otorhinolaryngology Division of University of Iowa, acknowledged the significance of OK-432 therapy and invited me to the States to present a lecture at the Annual Head and Neck Cancer and Reconstructive Surgery Course. I proposed a collaborative study of the therapy in order to obtain the FDA approval for OK-432 and we started the study together. I also gave explanations on clinical side of the treatment as well at the university. Because I do not have a doctor’s license in the U.S., I stood behind the residents and coached them on the procedures.

The girl who is living in Chicago, Shauna was diagnosed with lymphatic malformations in the bone, which was also known as Gorham-Stout syndrome. The lymphatic malformation in the bone melts her bone. In the first report of this disease, it was reported to have a “boneless arm.”

The lymphatic malformation of this girl extended from the second rib to the right shoulder joint. Half of the second rib cage had already melted, and respiration became difficult due to pleural effusion. As her father was an orthopedic surgeon, he was able to give an accurate diagnosis of his daughter. At the same time he understood that there was no treatment method for this disease. Losing all the hope, he was overwhelmed with grief. Soon, he heard about my treatment and contacted me. In fact, I did not know that such disease exists. I studied about this disease with the references provided by him.

I sent the medication, along with treatment procedures to him. Although this patient was living in Chicago,they flew to San Francisco to be treated by a famous pediatric surgeon. One or more faxes had been sent to me every day informing of the progress of the treatment and inquiry about the treatment method. There were times when I gave instructions on the treatment method by time schedule and its progress.

Shauna sent to me a letter of appreciation when all was finished successfully.

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