CiRA Foundation

CiRA Foundation
Activity Reportvol.
Message3

December2021

Aiming to make iPS cell therapy a common treatment option
How was 2021 for you, with all of the uncertainty due towork hard every day while dreaming of a future in which

COVID-19? In July, we decided to set up a facility in Osaka

medical treatment using iPS cell technology reaches

for the my iPS project to create iPS cells from patients' own

patients.

cells. We hope to start providing the iPS cells to medical

For us, 2021 was a year where we felt more than everinstitutions from 2025. In August, the project membersthat we were with all of you in our activities: donors who

moved to the Kyoto Research Park in order to securecooperate with blood collection, companies, medical

research space and to accelerate research andinstitutions and research institutes that use our iPS celld eve l o p m ent fo r m o re e ﬃ cient ce ll p ro duc tio n . In

stock, and donors who support

addition, we have also started providing to universities

our activities. May 2022 beand companies overseas iPS cell stock made from thea good year for you all.

blood of donors whose cell types are less likely to cause

Representative Director

immune rejection in many people when transplanted. TheShinya YAMANAKA

production of iPS cells for medical use is completed only
through strict adherence to the prescribed process anddetailed quality testing. Cell manufacturing is a continuous
process that requires steady and patient work, and weContribution

Contribution to the research on COVID-19

We are making the following eﬀorts to quickly clarify the onset mechanism and the causes of the diﬀerent severities of COVID-19.
●Providing iPS cells derived from COVID-19 recovering patients.
We performed the quality testing for the COVID-19 recovery patient-derived iPS cells established at the Center for iPS Cell Research andApplication, (CiRA) Kyoto University, and have been providing them free of charge to domestic and foreign research institutes (including commercialcompanies) since March 2021. This is a project to promote the research on COVID-19 with the cooperation of CiRA, Rinku General Medical Center,
Kyoto University Hospital. Through this project, we aim to contribute to the establishment of appropriate diagnostic, preventive, and therapeutic
methods for COVID-19.
●Genome analysis of COVID-19
We perform the genomic analyses of SARS-CoV-2 and the iPSC-derived airway cells and lung cells infected with SARS-CoV-2, commissioned byKyoto University Graduate School of Medicine, Kyoto University Hospital, and research institutes such as the National Institute of Infectious Diseases.
Through these analyses, we will contribute to the elucidation of the mechanism of virus infection, the rapid monitoring of virus mutant strains, andthe study of measures for controlling epidemics, and we will utilize the test methods for our research and quality evaluation of iPS cells.

Project1Accelerate my iPS project
New base in Kyoto Research Park

iPS cells diﬀerentiate into cells of various tissues and organs in the body. Patients can minimize the risk of rejection andother problems when transplanted with iPS cells made from their own cells. But on the other hand, custom-made treatment
for each patient may be expensive. Our my iPS project (hereafter referred to as "the project") aims to eﬃciently manufacture
iPS cells so that we can provide patients in need with self-derived iPS cells at an aﬀordable price. We have already decided toset up the manufacturing facility for the project at the International Hub for Healthcare Innovation in Nakanoshima, Osaka.
In July, the department responsible for the project branched oﬀ from the Facility for iPS Cell Therapy (FiT) as the Researchand Development Center, with the aim of providing cells from 2025. In August, the center relocated from the Kyoto University
campus to the Kyoto Research Park in Tambaguchi to provide suﬃcient space for its research and development activities,
which are expected to progress in the future. We have already started joint research with various organizations related to theproject, which will further accelerate our research and development.

The practical application of transplantation medicine using one's own iPS cells has great potential toovercome diseases that have been diﬃcult to treat in the past. Nearly 20 researchers are working on researchand development every day to put iPS cell-based medical care to practical use as soon as possible. There arestill many technical challenges to overcome in order to achieve both the safety and cost reduction of thismedical treatment and make it available to everyone. Innovative ideas and steady research are essential.
There are several issues that we cannot solve on our own, such as the design of automated equipment andthe introduction of AI-based image processing technology. Our mission is to overcome these diﬃculties withthe tremendous support and cooperation of corporations, universities, hospitals, and other organizations,both domestic and international, and this is the most "rewarding" challenge for us.

Masayoshi TSUKAHARA,
Head of Research and Development Center

my iPS Project Practical Application Model
Establishment of a technology platform
Development of a series of infrastructureThe my iPS project facility（International Hub for Healthcare Innovation※）

Medicalinstitutions

Consultation
Desk●Reception andconsultation

MedicalExamination●●

Medical interview
Tests forinfectious diseases,
etc

Blood sampling

Medicalinstitutions（Images of the inside of the my iPS project facility）

Cell Reprogramming /Expansion culture of iPS cells※The International Hub for Healthcare Innovation

Induction ofdiﬀerentiationfrom iPS cells

A unique center in Japan that features a concentration of medical
institutions, companies, start-ups, and support organizations underone roof. The Organization for Advanced Healthcare Innovation, ageneral incorporated foundation established by private companies andOsaka Prefecture, will be responsible for the operation of the center.

Patients

Treatment with
diﬀerentiated cells
from iPS cells

External CPC

Frozen storage of cells

Induction of diﬀerentiationfrom iPS cells

A day in the life of a researcher at the R&D CenterTopics

9AM

Going to work

I took my child to apreschool and went to workat 9:00. I usually listen toYuko KITANO
Responsible forprocess development
for my iPS project

music on my way to work toboost my motivation.

Morning work
I checked my email to see if there was any
urgent work to be done. After that, I had ameeting with other staﬀ members toensure that the day's work goes smoothly
and prepare to start my research.
We are examining what the best facilities
for iPS cell production look like and how
they should be designed to reduce costs.
Today, we also compared the equipment

12PM

that might be useful for our project.

Lunch time

I bought a lunch nearby and ate it at
my desk to protect myself fromCOVID-19.

Afternoon work
We discussed how to extract the source of iPS cells fromblood with the company. When creating iPS cells, we canuse fresh blood that has not been stored for a long time,rather than the commonly used commercially available
somatic cells. This is only possible thanks to thecooperation of our blood collection volunteers. The
project's goal is to provide safe and eﬀective medical care
for all patients who wish to receive it. To achieve this, it isnecessary to eﬀectively treat a wide range of blood types,
with diﬀerent conditions for diﬀerent people. I am
grateful every day to all the volunteers. In addition to the5PM

End of work

meeting, I also wrote papers and prepared materials forconferences.

I am currently working shorter hours to raise my child. But
thanks to the support of my colleagues, I have managed toget my work done. Every time I ask them to take over a task

● In closing

on a day oﬀ or after hours, I feel sorry for myself and renew

When I was a student, I studied embryology in the hope that mymy resolve that I will support the next generation ofresearch would lead to helping people, and now I feel that desire

colleagues as they raise their children. Although I amagain. There is still a lot of research and development to be done

inevitably pressed for time, my supervisor leaves it to me tobefore this project becomes a medical system that can actually be

manage my time, which makes it easy for me to work.

provided, but I will continue to do my best while maintaining agood balance between work and family.

Project2

Toward the realization of therapies to regenerate cartilage

It is very diﬃcult for articular cartilage tissue to self-repair once it is damaged. One of the eﬀective treatment approaches is
to take out the patient's own cartilage tissue, culture it, and transplant it into the damaged area. But with this approach, thepatient has to undergo surgery twice. Professor Tsumaki has been conducting clinical research to treat patients who havedamaged cartilage in their knee joints using cartilage made from iPS cells.
In 2019, he submitted a plan for the provision of regenerative medicine to the Japanese government. We have been
assisting him in many ways to ensure that his project proceeds eﬃciently, including regulatory compliance and coordination
with Kyoto University Hospital, with which he is collaborating. The cartilage for transplantation was also manufactured at FiT
using our iPS cell stock. Even though we have extensive experience in manufacturing and quality testing iPS cell-derived
processed products, we are nervous about cooperating in such clinical research. Working towards the same goal as theresearchers is very rewarding for us. We will continue to play our role in realizing clinical applications using iPS cell
technology while staying close to the researchers.
Based on his own experience as an orthopedic surgeon, Professor Tsumaki hopes to cure patients'
diseases and disorders as much as possible. He has been engaged in a wide range of research, including
basic research on the function of genes that are important for cartilage formation and diﬀerentiation, drug
discovery research to ﬁnd therapeutic agents for bone system diseases, and regenerative therapy research
for iPS cell-derived cartilage transplantation.
Graduate School of Medicine /Flontier Biosciences, Osaka University
Center for iPS Cell Research and Application（CiRA）, Kyoto University
Aﬀected part(cartilage)

Noriyuki Tsumaki M.D., Ph.D.

AllograftPatients

iPS Cells

ThanksChondrocytes

Cartilage TissuetransplantThank you for your support of our activities

We are engaged in "translational" activities to support the transfer of university-originated technology to companies
toward the practical application of new medical care using iPS cells. It is important that medical institutions, pharmaceuticalcompanies, venture companies, etc. succeed in commercializing treatments and medical technologies using iPS cells, andthat they eventually reach the people who need them. By producing quality-assured iPS cells for regenerative medicine andproviding them free of charge to non-proﬁt institutions and at a low price to for-proﬁt institutions, we hope to promote theentry of research institutes and companies into this ﬁeld, shorten the time required for the practical application of iPS
cell-based medicine, and reduce R&D costs. Our activities are supported by public research funds and project income, as well
as by your donations. We would like to thank you again for your donations, which are helping us to build bridges withindustry and deliver iPS cell technology to patients.

CiRA Foundation
Activity Report vol.3Published on April 11, 2022

CiRA Foundation
53 Shogoin kawahara-cho,Sakyo-ku, Kyoto 606-8397, Japan.

www.cira-foundation.or.jp