Masayo Takahashi received her M.D. in 1986, and her Ph.D. in 1992 from Kyoto University. After an assistant professorship in the Department of Ophthalmology, Kyoto University Hospital, she moved to the Salk Institute in 1995, where she discovered the potential of stem cells as a tool for retinal therapy. She returned to Kyoto University Hospital in 1997, and was appointed associate professor at the Translational Research Center in the same hospital in 2001. She joined the RIKEN as a team leader of the Lab for Retinal Regeneration in 2006. In 2013, her team launched a pilot clinical study of autologous iPS cell-derived RPE cell sheets for exudative aged-related macular degeneration (AMD), and performed the first RPE cell sheet graft transplantation in Sept. 2014. In 2017, the team started using allogeneic iPS cells suspension in the clinical study.

1. Walking toward challenging dream
Masayo Takahashi, M.D., Ph.D.
RIKEN Center for Biosystems Dynamics Research (RIKEN BDR)
Project Leader, Laboratory for Retinal Regeneration
Kobe Eye Center, Kobe City Medical Center
Public Interest Incorporated Association NEXT VISION

2. Google’s next field is medicine
Google CEO announced in 2018.6
Retinal fundus photograph

3. Kobe Eye Center
(2) Ophthalmology
hospital
Kobe City Eye Hospital
(1) Research
RIKEN institute
Patients
with
retinal disease
Retinal
examination,
imaging
Regenerative
medicine
RPE cells
Genetic diagnosis
Gene therapy
Genetic
counseling
(3) Rehabilitation and social experiment
Public interest Incorporated association NEXT VISION
Vision Care Inc. (VC’)
Visual
rehabilitation
development
Hibernation
research
Patient iPSCs
Drug discovery/
development
Regenerative
medicine
Photoreceptors
AI/robotics
Low vision care
device development
Automated
driving

4. The Salk Institute（1995-1996）
Prof. Gage
Neural stem cells 1995〜
Believe & doubt

5. iPS cells 2006〜
5
iPS cell-derived
retinal pigment epithelial cell sheet

6. Nature 504, 7480;357-365 (19 December 2013)
Five to watch in 2014 .
Masayo Takahashi, RIKEN Center for Developmental Biology
Induced pluripotent stem cells could get their first test in the
clinic.
Chris Field, Intergovernmental Panel on Climate Change
As co-chair of the upcoming report on the impacts of climate change
Jean-Pierre Bourguignon, Incoming president, European Research
Council
When the French mathematician replaces Helga Nowotny, he will enjoy a
bigger budget but must protect the grant-giving institution from political and
bureaucratic pressures.
Koppillil Radhakrishnan, Chairman, Indian Space Research
Organisation India’s Mars Orbiter Mission
Gordon Sanghera, Chief executive, Oxford Nanopore
the UK company’s MinION genetic sequencer. If it lives up to its promise,
the device could usher in a new era of dramatically faster, cheaper
sequencing.

7. SURGERY ROOM
（SEP.12.2014）

8. Nature 516: 287-444 (18 December 2014)
365 days: Nature's 10
Ten people who mattered this year. 2014
1. ANDREA ACCOMAZZO: Comet chaser
2. SUZANNE TOPALIAN: Cancer combatant
3. RADHIKA NAGPAL: Robot-maker
4. SHEIK HUMARR KHAN: Ebola doctor
5. DAVID SPERGEL: Cosmic sceptic
6. MARYAM MIRZAKHANI: Surface explorer
7. PETE FRATES: Ice-bucket challenger
8. KOPPILLIL RADHAKRISHNAN: Rocket launcher
9. MASAYO TAKAHASHI: Stem-cell tester
10.SJORS SCHERES: Structure solver
Brave scientist !

9. BasicresearchBasicresearch
Application
research
Application
research
Translational
research
Translational
research
Clinical
research
Clinical
research
ClinicaltrialClinicaltrial
Industrialization
(treatment)
Industrialization
(treatment)
1996 2001 2007 2011 2014 2017 2020
From basic research to clinical application
Why How
Retinal regeneration? Impossible !
ES cells can be used for treatment? never!
iPS cells are too dangerous. Don’t think about clinical use!
Don’t think about industriariization before clinical success
Retinal diseasesRetinal diseases
Test, Treatment
RetinalRetinal
cell biologyStem cells, genetics MarketMarket
Business
Nerual stem cell ES cell iPS cellsNerual stem cell ES cell iPS cells HEALIOS

10. Abduction from the future goal
Rules should be changed if it is not suitable for the goal
Present
Future A
Future B
Future C
Rule
Rule
Good treatment
Patient benefit
Cell
Scientific hurdles

11. Regenerative medicine
Progress of basic research
& technology
PassPass
Goal !!
Well prepared
Running to the goal
Time

12. Regulation for cell therapy in JapanRegulation for cell therapy in Japan
【Regenerative medicine 2014.11.25~ 】
※Earlier Patient Access !
Informed Consent and Post Market
Safety Measures
Marketing
(further confirmation
of efficacy and safety)
Adaptive
Licensing with
condition
Clinical
Research
Approval or
Expiration of
provisional
approval
Marketing
Clinical Trial
(confirmation of
probable benefit*
and safety**)
* Probable benefit: Confirmation of efficacy with small patient population.
** Safety: Earlier detection and evaluation of adverse events.
Enforcement 2015.11.25~
Marketing
(further confirmation
of efficacy and safety)
Application
Clinical research
(Act on the safety of regenerative
medicine) forced on Nov 25, 2014
Clinical trial
(revised Pharmaceutical affairs act)
forced on Nov 25, 2014
Basic
research
Preclinical
research
Reverse Translational research Physician
Company

13. Stepping stone
https://4travel.jp/travelogue/11002351
Turtle stones in Kamogawa, Kyoto

14. Little improvement every day
Time course

15. Progress of retinal cell therapy
Auto RPE
Allo RPE
Multicenter
+Photoreceptor
Universal cells?
(HLA KO + HLA E)
Safety Efficacy, System

16. Patient with AMD
RPE cell sheet
Pure RPE cell
Skin fibroblasts
Gene transfer
Transplantation
iPSC
Induction of differentiation
Skilled technologists are essential
Skilled technologists constitute a rate-limiting
factor for continuous production

17. LabDroid Maholo Two seven-axis arms
(photo provided by Dr. Natsume of the National Institute of
Advanced Industrial Science and Technology)

18. Kobe Eye Center
(2) Ophthalmology
hospital
Kobe City Eye Hospital
(1) Research
RIKEN institute
Patients
with
retinal disease
Retinal
examination,
imaging
Regenerative
medicine
RPE cells
Genetic diagnosis
Gene therapy
Genetic
counseling
(3) Rehabilitation and social experiment
Public interest Incorporated association NEXT VISION
Vision Care Inc. (VC’)
Visual
rehabilitation
development
Hibernation
research
Patient iPSCs
Drug discovery/
development
Regenerative
medicine
Photoreceptors
AI/robotics
Low vision care
device development
Automated
driving

19. Taku Miyake, M.D., CEO, Studio Gift Hands, Inc.; Research Center for Advanced Science and Technology, The University of Tokyo;
Department of Ophthalmology, Tokyo Medical University; industrial doctor
Digital low vision care
Visible memories,
arising thoughts

20. Low vision eyeglasses
At your service at last
A wearable low-vision device for people with night blindness
Improved vision in low light and at night
Low vision aid device
Fully operable on the handheld
controller

21. OTON GLASS CEO Shimakage
Low vision care device, vision support system developed

22. Orcam My Eye 2.0 with AI

23. Kobe Eye Center
(2) Ophthalmology
hospital
Kobe City Eye Hospital
(1) Research
RIKEN institute
Patients
with
retinal disease
Retinal
examination,
imaging
Regenerative
medicine
RPE cells
Genetic diagnosis
Gene therapy
Genetic
counseling
(3) Rehabilitation and social experiment
Public interest Incorporated association NEXT VISION
Vision Care Inc. (VC’)
Visual
rehabilitation
development
Hibernation
research
Patient iPSCs
Drug discovery/
development
Regenerative
medicine
Photoreceptors
AI /robotics
Low vision care
device development
Automated
driving

24. Entrance floor with
books
bouldering walls
driving simulators
devises