1.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
2.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
3.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
4.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
5.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
6.Original Meaning of Concurrent Exogenous and Endogenous Factor Disease Pathology in Oriental Medicine
Kampo Medicine 2012;63(6):407-416
In oriental medicine, when an exopathogen enters the body, the inner spirits (内精) and the exopathogen conflict with each other. Disease occurs in this deficient condition of inner spirits. In most classical formulary, such as the Shanghanlun (傷寒論), the cause of disease is regarded as the external circumstance, such as the cold, the wind or warmth. Here, the authors surveyed the significance of exopathogens and endogenous factors in medical books such as the Shanghanlun, as well as the Jinkuiyaolue (金匱要略), the Suwen (素問), the Lingsue (霊枢) and the others, to obtain the results herein. In the original pathology of a disease concurrent with both an exogenous and an endogenous factor, there is conflict between well-regulated seasonal Qi (四時正気) and unregulated inner spirits. Previous to the development of internal mechanisms for disease causes,this concurrent pathology thinking is concerned significantly with the external world and Shenxien (神仙) thought. Furthermore ambiguities arise from various relationships between exogenous factors and endogenous factors.
7.The Formation of Decoctions from Pills and Powder Formulations in Shanhanlun
Jiro ENDO ; Tatsuhiko SUZUKI ;
Kampo Medicine 2011;62(2):152-160
This paper reveals the formation of the decoctions in the Shanhanlun by comparisons of its pills, powders formulations and decoctions. In the early medicine found in the Huatuofang, pills and powder formulations, which have intense diaphoretic, emetic and laxative effects, were adopted. Although the Shanhanlun steers away from these extreme medicines, in the chapter Kebukepian there are two medical indications for such pills and powder formulations for basic treatment, and for such decoctions for relatively complicated symptoms of diseases. Focusing on the decoction preparations:the doses of the decoctions are related to those of the pills and the powder formulations. In addition, some of the decoction ingredients come from soup or gruel to take with a pill or a powder formulation. These mean that dosage forms are changed from pills and powders, to decoctions in stages. We therefore conclude that the decoctions in the Shanhanlun are derived from pills and powder formulations.
8.Study on the School of Traditional Japanese Medicine in the Dose and the Usage Directions of Medication
Kampo Medicine 2011;62(3):382-391
The authors studied the doses and usage directions for some of the first Traditional Japanese Medicines (TJM) and reached the following conclusions. Since Dosan Manase, who had strong influence on TJM, adopted a method of selecting drugs one by one and refused to use fixed prescriptions, it has been hard to comprehend how much of any drug he administered. As criterion, he showed a half common system of weights. Ekiken Kaibara defined an extremely small dose as 1 ∼ 2 qian. Todo Yoshimasu set around 3 qian as the quantity for one dose, although he calculated that 1 liang was equivalent to about 2 qian (7.5g). Additionally, the Koshogaku school proposed that 1 liang was equivalent to 1.4g.
9.Research on “Shu Ho Ki Ku”
Kampo Medicine 2005;56(3):435-444
This research investigated the “Shuhokiku, ” an Edo-era bestseller, said to have been authored by Manase Dosan (1507-1594) and supplemented by Manase Gensaku (1549-1631), The investigation yielded the following results:
(1) “Shuhokiku” is surmised to be the oral discourse of Manase Gensaku's disciple, Okamoto Genya (1587-1645), transcribed by Genya's student.
(2) Of the prescriptions included in the “Shuhokiku, ” seventy percent are quotations from Gong Ting Xian's medical treatises. There are numerous quotes from Gong Ting Xian's works, particularly the “Wanbing Huichun”; prescriptions stemming from this medical manuscript account for sixty percent of the prescriptions in the “Shuhokiku”.
(3) The “Shuhokiku” is based on a medical system of “basic and modified prescriptions.” The numerous modified prescriptions cited in the “Shuhokiku” demonstrate that the work relied heavily on the “Wanbing Huichun.”
(4) Various editions of the “Shuhokiku” are classified into three groups.


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