alexa A New National Framework for Clinical Trials and Evalua
ISSN: 2161-0991

Journal of Transplantation Technologies & Research
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Review Article

A New National Framework for Clinical Trials and Evaluation of Innovative Medical Care Technologies Using Living Cell Transplantation in Japan

Kiyoshi Okada1,2*

1Department of Orthopaedics, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

2Department of Medical Innovation, Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka 565-0871, Japan

*Corresponding Author:
Kiyoshi Okada
Department of Medical Innovation
Osaka University Hospital, 2-15 Yamadaoka
Suita, Osaka 565-0871, Japan
Tel: +81-6-6210-8289
Fax: +81-6-6210-8301
E-mail: [email protected]

Received Date: July 25, 2014; Accepted Date: September 27, 2014; Published Date: September 30, 2014

Citation: Okada K (2014) A New National Framework for Clinical Trials and Evaluation of Innovative Medical Care Technologies Using Living Cell Transplantation in Japan. J Transplant Technol Res 4: 137. doi: 10.4172/2161-0991.1000137

Copyright: © 2014 Okada K. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



Following the global initiative to develop medical innovative technologies such as living cell transplantation, the Japanese promotion plan, “Five-year Clinical Trial Vitalization Plan 2012” was launched in 2012. Subsequently, “Clinical Trials Core Hospitals” or medical care institutions that performed research and development of innovative technologies were identified, which were regularly evaluated by the “Evaluation System for Investigational Medical Care.” In addition, the regulatory guidelines for pharmaceuticals and medical devices have been reexamined and the revised Pharmaceutical Affairs Law (PAL), which was renamed as the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act (PMD Act), and the Act on the safety of regenerative medicine were developed in 2013 and is scheduled for implementation in November 2014. Based on these changes in the national framework for innovative medical care in Japan, this article aims to explain and evaluate the possibility for this framework to be utilized as the universal case model for stem cell and living cell transplantation.


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