Regenerative Medicine Policy Research Unit

Established : Dec. 18, 2008

Photo by AP/AFLO



Regenerative medicine has achieved impressive results in clinical applications on localized articular cartilage defects and skin damage caused by burn-wounds. However, the regenerated tissue used in these cases has a unitary construction, lacks mechanical strength and has a substantial limitation in its repairable size and structure. As the loss of tissue due to aging or lesion found widely in clinical practice is relatively extensive and complex, there is a need for research and development on complex 3D tissue regeneration that will result in new enhanced applications.

It is hoped that the widespread adoption of such technologies will contribute to improved treatments. However, since there are no laws or regulations that cover tissue regeneration adequately under the current system in Japan, there is a pressing need to update the regulatory framework in order to industrialize complex 3D tissue regeneration technology and its clinical application. This unit examines 1) establishment of a practical review system, 2) the technology required for multicenter tissue cultivation, control and transportation, and 3) sets of evidence to resolve the issues they raise. In addition, this unit communicates information which promotes the proposals outlined above.


Presently, in Japan, problems are caused by a lack of law and regulation covering regenerative medicine that uses autologous cells other than the expedient application of the Pharmaceutical Affairs Act. To be more precise, not many companies have achieved the target level on evidence of safety and efficacy required for pharmaceutical approvals, and hence are insecurely placed with regard to their own development goals. The outward or inward transportation of cells and tissues between different institutions is prohibited, while the type of tissue technology created and established by one institution may not be shared with others. These factors militate against successful research and development and hamper the production and spread of complex 3D tissue regeneration technology.

This research unit shows what evidence is required to enact various regulations, establish systems of implementation and resolve a variety of issues, with a view to rapid regulatory and institutional reform. We aim to disseminate our findings on complex 3D tissue regeneration within the medical profession, and thereby promote the development of new-generation medical devices and composites.


Tsuyoshi Takato (Professor, Division of Tissue Engineering, the University of Tokyo Hospital)


Kazuto Hoshi (Associate Professor, Division of Tissue Engineering, the University of Tokyo Hospital)
Yuichi Tei (Professor, Graduate School of Engineering, School of Engineering, the University of Tokyo)
Hiroyuki Koyama (Project Associate Professor, Division of Tissue Engineering, the University of Tokyo Hospital)
Ryoko Hatanaka (Project Researcher, Policy Alternatives Research Institute)