●Editorial | Fukushima M | 4-5 | Full text | |
●TRI 10th Anniversary Symposium 1st World Centenarian Initiative Overcoming neuronal system refractory diseases: The current situation and future prospects for the development of innovative therapies for spinal cord injury Organized by:Translational Research Informatics Center, Foundation for Biomedical Research and Innovation Co-organized by:Association for Preventive Medicine of Japan | 7-63 | Abstract | ||
Opening remarks | Fukushima M | 9-10 | ||
Activities of Japan Spinal Cord Foundation, what patients think, and hope for developments of new therapies | Ohama M | 11-4 | ||
The current situation of clinical trials on stem cell therapy for spinal cord injury in the world | Omae K | 15-7 | ||
Spinal cord injury ─ Pathophysiology and requisites for a new therapeutic approach ─ | Yoshimine T | 18-22 | ||
Leading edge of HAL® and medical challenges | Sankai Y | 23-8 | ||
HAL® clinical trial in Germany for patients with spinal cord injury | Schildhauer TA | 29-30 | ||
Basic strategy for HAL® medical application in physician-initiated, GCP-regulated clinical studies for brain, spinal cord, neuro-muscular disorders | Nakajima T | 31-8 | ||
Basic study using bone marrow stromal cells for spinal cord injury | Ide C | 39-45 | ||
The clinical trial of spinal cord regeneration therapy by autologous bone marrow-derived cells | Suzuki Y | 46-9 | ||
Autologous bone marrow mesenchymal stem cell therapy for spinal cord injury | Yamashita T | 50-4 | ||
Olfactory mucosal autografts for chronic complete spinal cord injury | Iwatsuki K | 55-9 | ||
Panel discussion | 60-1 | |||
Summation and closing remarks: Future vision for spinal cord injury treatments | Fukushima M | 62-3 | ||
●Translational Research Center Workshop Management & acceleration strategies of translational researches Organized by:Translational Research Informatics Center, Foundation for Biomedical Research and Innovation | 65-105 | Abstract | ||
Opening remarks: Welcome to this workshop | Saruta T | 67 | ||
National strategies to promote translational researches in Japan | Inoue T | 68-71 | ||
Reports on visits to translational research centers in US | Nagai Y | 72-9 | ||
Translational research initiatives in Singapore: Singapore’s biomedical initiative | Koh S | 80-6 | ||
Translational research initiatives in Germany: Experiences on cell processing services | Schmiedeknecht G | 87-94 | ||
Inserm Transfert: A key to access French excellence in biomedical research | Godard A | 95-102 | ||
General discussion | 103-4 | |||
Closing remarks | Fukushima M | 105 | ||
●Articles | ||||
Clinical development of metreleptin for lipodystrophy | Ito T,Tada H, Tanaka S,et al. | 107-17 | Abstract | |
Information disclosure on clinical trials by the national registries and regulatory agencies in Japan, US, and EU | Hoshi J,Fujii H, Takasaki K,et al. | 119-26 | Abstract | |
The consideration about the file name of the unified form in the application of electromagnetic records of Clinical Trial-related Documents | Wakai S,Yamamoto M, Kusuoka H | 127-31 | Abstract | |
●Translation | ||||
The GRADE approach for assessing new technologies as applied to apheresis devices in ulcerative colitis | Ibargoyen-Roteta N, Gutiérrez-Ibarluzea I, Rico-Iturrioz R,et al. (trans. by Aihara M) | 133-47 | Full text | |
●Forum | ||||
My proposal for conducting clinical trials at the phase III & IV, after reading the articles on Tamiflu appeared in Swiss Newspapers | Suzuki S | 149-51 | ||
●Instructions for authors[Japanese]&[English] | 153-61 | Full text | ||
●Editor’s note | Kageyama S | 163 | Full text |