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  3. Toward development of cell therapy for renal diseases using iPS cells Joint research on the development of monitoring methods for the quality and manufacturing processes of nephron progenitor cells



Toward development of cell therapy for renal diseases using iPS cells Joint research on the development of monitoring methods for the quality and manufacturing processes of nephron progenitor cells

Rege Nephro Co., Ltd. (Headquarters: Sakyo-ku, Kyoto, Representative Director: Toshihiro Ishikiriyama, hereinafter “Rege Nephro”), Center for iPS Cell Research and Application, Kyoto University (Headquarters: Sakyo-ku, Kyoto, Director: Shinya Yamanaka, hereinafter “CiRA”), CiRA Foundation (Headquarters: Sakyo-ku, Kyoto, Representative Director: Shinya Yamanaka, hereinafter “CiRA_F”), NIKKISO CO., LTD. (Headquarters: Shibuya-ku, Tokyo, President and CEO: Toshihiko Kai, hereinafter “NIKKISO”), Shimadzu Corporation (Headquarters: Nakagyo-ku, Kyoto, President and CEO: Teruhisa Ueda, hereinafter “Shimadzu “), have signed a joint research agreement on the development of monitoring methods for quality and manufacturing processes of nephron progenitor cells 1).

Under this joint research agreement, we will analyze proteins, metabolites, etc. by mass analysis toward the development of cell therapy for renal diseases using nephron progenitor cells produced from human iPS cells: HLA-homozygous 2) iPS cell strains. We will identify the therapeutic effect factors secreted by the nephron progenitor cells. In addition, we will analyze unintended cells and impurities generated in the differentiation induction and expansion culture processes of nephron progenitor cells, improve these processes and develop a quality and manufacturing process monitoring method.

Rege Nephro is a venture company established in September 2019 based on the research results of Professor Kenji Osafune of Department of Cell Growth and Differentiation, CiRA. Professor Osafune has succeeded in establishing a technology for highly efficient production of nephron progenitor cells from iPS cells, starting with the world’s first discovery of the existence of nephron progenitor cells, which are a type of renal progenitor cells during the embryonic period.

The number of patients suffering from chronic kidney disease (CKD) is increasing with the aging of society, and the number of patients with CKD is 13% of the adult population in Japan, reaching about 13 million. Effective medicines and treatment techniques for the treatment of CKD are currently hardly available, except for kidney transplants, which have serious donor shortage problems, hence there is no choice but to give symptomatic treatment. When CKD deteriorates, dialysis becomes necessary, but the number of dialysis patients is increasing year by year, and the annual medical expenses exceed 1.5 trillion yen. The development of technology to improve the symptoms of CKD and reduce the number of dialysis patients is an urgent social issue.

The iPS cell-derived nephron progenitor cells invented by Professor Osafune have been shown to improve renal damage in animal experiments. In the future, Rege Nephro will work on the practical application of cell medicine containing iPS cell-derived nephron progenitor cells as an active ingredient, aiming to obtain approval for CKD as an indication.

In this joint research, the Osafune laboratory led by Professor Osafune will play a leading role in the identification of therapeutic effect factors.

CiRA_F will provide a master cell bank of HLA-homozygous iPS cell lines used to induce differentiation to nephron progenitor cells in this joint research.

In this joint research, NIKKISO will provide an expanded culture system for nephron progenitor cells under development using the technologies that NIKKISO has cultivated in its existing businesses, such as fluid control technology and component measurement technology.

Shimadzu plays a central role in the analysis of proteins and metabolites by providing analytical measurement equipment and technologies such as liquid chromatograph mass spectrometer (LC-MS). The company will continue to promote open innovation in the research and development of cell culture solutions in order to support research institutes and companies involved in cell research and cell-related industries.

Rege Nephro will further secure the manufacturing process of cell therapy, which is currently under development, in terms of quality and manufacturing process monitoring by concluding a joint research agreement this time CiRA, CiRA_F, NIKKISO, and Shimadzu. Rege Nephro will promote its business under the mission of improving the quality of life (QOL) of patients suffering from kidney disease and contributing to society.

Note 1) Nephron progenitor cells
Cells that produce tissues called nephrons (glomeruli and tubules) that produce urine in the kidneys. There are separate cells that are the source of the ureter, which is the drainage channel for urine, and interstitial progenitor cells that fill the gaps in the kidney tissue.

Note 2) HLA-homozygous
HLA is an abbreviation for Human Leukocyte Antigen, which is a major histocompatibility complex of humans, and is a type that distinguishes between own cells and others. HLA is distributed not only in white blood cells but also in almost all cells and acts as an important molecule involved in human immunity. When cells or organs are transplanted from a person with an HLA type that is different from the type the recipient has, the body recognizes it as a “foreign body” and causes immune rejection. Therefore, when transplanting cells and organs, it is important to match the mutual HLA type as much as possible to weaken immune rejection. If you inherit the same HLA type from your father and mother, you are called an “HLA homozygous.”

<Overview of Rege Nephro>
Rege Nephro Co., Ltd.
Representative Director: Toshihiro Ishikiriyama
Address: Med-Pharm Collaboration bldg. Kyoto University
46-29 Yoshida Shimoadachi-cho, Sakyo-ku, Kyoto
Business: R & D, production and sales of therapeutic agents for renal diseases Established: September 2019
URL: https://www.regenephro.co.jp/en

<Overview of CiRA>
Center for iPS Cell Research and Application, Kyoto University
Director: Shinya Yamanaka
Address: 53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
Department in charge: Osafune Laboratory, Center for iPS Cell Research and Application, Kyoto University
Established: April 2010
URL: https://www.cira.kyoto-u.ac.jp/e/index.html

<Overview of CiRA_F>
CiRA Foundation
Representative Director: Shinya Yamanaka
Address: 53 Shogoin kawahara-cho, Sakyo-ku, Kyoto
Business: Cell manufacturing, quality evaluation, cell storage management and cell processing center management and operation
Established: September 2019
URL: https://www.cira-foundation.or.jp/e/

<Overview of NIKKISO>
President and CEO: Toshihiko Kai
Address: Yebisu Garden Place Tower 22nd floor, 20-3 Ebisu 4-Chome, Shibuya-ku, Tokyo, Business: Manufacture and sales of industrial specialized pumps and systems, medical equipment, aircraft parts, etc.
Established: March 1950
URL: https://www.nikkiso.com/

<Overview of Shimadzu>
Shimadzu Corporation
President and CEO: Teruhisa Ueda
Address: 1 Nishinokyo Kuwabara-cho, Nakagyo-ku, Kyoto
Business: Manufacture and sale of measuring equipment, medical equipment, industrial equipment, aviation equipment, etc.
Established September 1917
URL: https://www.shimadzu.com/