© Peter Maloca. CC BY

The Principles Of Regenerative Medicine | 20 December 2019


Masanori Fukushima, TRI Director, Foundation for Biomedical Research and Innovation at Kobe, Translational Research Center for Medical Innovation (TRI)

Throughout its history, humanity has battled to overcome diseases and disorders. This struggle has yielded revolutionary discoveries that have transformed medical care. For example, in the early 20th century, French surgeon Alexis Carrel developed a technique for sewing blood vessels together, which is used in many surgical procedures including organ transplants. During the same decade, Canadian physician Frederick Banting discovered insulin. A few years later, Scottish bacteriologist Alexander Fleming discovered penicillin; this discovery and subsequent developments made many infectious diseases treatable and triggered an explosion in drug discovery.

In this way, humanity has gained considerable control over many diseases. However, drugs have actually had a limited effect on extending life expectancy since the most important factors for extending human life, namely improving health and nutrition, depend on escaping from poverty. Consequently, most diseases still remain a long way from being overcome.

Nevertheless, you are probably aware of a recent series of breakthroughs in addressing diseases for which there are currently limited treatment options: the practical application of regenerative medicine by using stem cells derived from the human body. For instance, a patient with severe spinal cord injury, who had been unable to move and initially received a hopeless prognosis, was able to recover by receiving stem cell treatment. His recovery is movingly portrayed in a video showing him sufficiently recovered to be able to walk home. I believe that necessary evidence from clinical trials will soon help make this kind of dramatic improvement a clinical reality for many.

"This collection describes the paradigm shift occurring in medicine."

This collection of articles describes six emerging treatments approaches involving the regeneration of nerves, blood vessels, myocardium, cornea, eardrum and bone. The techniques involving the regeneration of nerves and eardrum have been approved for manufacture and sale by the Japanese medical regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA)1, while the other four therapies have been favourably received in Japanese registration trials. Regenerative therapies are characterized by the use of stem cells, or depending on the type of injury, stem cells in combination with tissue engineering.

Some of the investigational approaches described in this collection were showcased in a Nature Outlook on Regenerative Medicine2 and five Nature Outlines3–7, sponsored by TRI and others, which all received positive feedback. Based on this response, we have produced this collection, titled The Principles of Regenerative Medicine, to provide further information on the treatments. It outlines the theory behind their common principles and explains the specifics of each treatment method. In the future, we intend to report on treatments for other difficult diseases based on new therapeutic principles. But the present collection describes the paradigm shift occurring in medicine. We live in a time of unprecedented scientific and technological revolution. Ten years from now, humankind will surely have devised a specific road map for overcoming the major diseases of our time, and we will enter an age in which, by concerting our efforts, the journey’s end will be near8,9.

The Foundation for Biomedical Research and Innovation at Kobe, Translational Research Center for Medical Innovation (TRI), is a Japanese public institution that supports clinical trials led by academia. As TRI’s director, I am very proud to endorse this publication.


  1.  Pharmaceuticals and Medical Devices Agency [pdf; in Japanese] |article
  2. Nature Outlook: Regenerative Medicine, Nature 540, S49 (7 December 2016) | article 
  3. Nature Outline: Corneal Repair, Nature 544, 7650_supp_out (20 April 2017) | article
  4. Nature Outline: Eardrum Regeneration: Membrane Repair, Nature 546, 7659_supp (22 June 2017) | article
  5. Nature Outline: Critical Limb Ischaemia,Nature 548, 7668_supp (24 August 2017) | article
  6. Nature Outline: Non‐union bone fracture: a quicker fix, Nature 550, S193 (26 October 2017) | article
  7. Nature Outline: Spinal‐cord Injury: Spurring Regrowth, Nature 552, 7684_supp (14 December 2017) | article
  8. Fukushima, M., Austin, C., Sato, N., Maruyama, T., Navarro, E. et al. The global academic research organization network: Data sharing to cure diseases and enable learning health systems. Learning Health Systems e10073 (2018) | article
  9. From Lab to Clinic, TRI Advances website| article

Read this next

Feature | 8 August 2019

Spinal cord treatment using stem cells

After a small-scale clinical trial, a promising stem-cell treatment for spinal cord injuries is now available in Japan

Feature | 26 October 2017

Stem cell therapies demonstrating their potential

CD34 positive stem cells could be used to treat a wide range of medical conditions

Feature | 7 March 2018

Living well to a hundred and beyond

The public were given a preview of therapies that promise to preserve the quality of life of people well into old age