clinical development of regenerative medicine … ª式会社セルシード...
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株式会社セルシードJASDAQグロース 証券コード:7776
Clinical Development of Regenerative Medicine
Products Based on Cell Sheet Engineering
Technology in Japan and Europe
Setsuko Hashimoto, Ph.D.
President and CEO
Copyright © 2015 CellSeed Inc. All Rights Reserved.
Universities Source of
innovation
Hosp
itals
Patie
nts
products
Research collaborataion
seeds fee
therapy
Product development
Approval
Manufacturing
Business collaboration
partner companies
fee
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Missions of CellSeed
To bring regenerative medicine to the patients
To introduce our unique platform technology for regenerative medicine,
“cell sheet engineering” globally To initiate health innovation by providing safe and high quality products
Copyright © 2015 CellSeed Inc. All Rights Reserved.
Corporate overviewEstablishment May, 2001Basic technology Cell-sheet engineering using temperature-responsive polymers Business • Cell Sheet Regenerative Medicine
• Intelligent cell culturewareHead office Katsura Bldg., 4F, 3-61 Haramachi, Shinjuku-ku, Tokyo 162-0053
Directors President and CEO Setsuko Hashimoto, Ph.DExecutive Director Katsumi KatayamaExecutive Director Hiroshi YoshidaExecutive Director Eiji TakagiAuditor(External) Teruo Okano, Ph.DAuditor Ichiro KobayashiAuditor(External) Noriko SawaiAuditor(External) Toshio Yamaguchi
Fiscal year January - DecemberNo. of employees 30 (as of April 30, 2015)Publicly listed on JASDAQ (in 2010)
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Copyright © 2015 CellSeed Inc. All Rights Reserved.
Core competence: Cell sheet engineeringTemperature-responsive polymers allow recovery of intact cells in a sheet form. Developed by Prof. Teruo Okano, Tokyo Women’s Medical University, Japan
Intelligent surface of the cultureware37℃ hydrophobic ⇔ 20℃ hydrophilic
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Copyright © 2015 CellSeed Inc. All Rights Reserved. 4
Advantages of Cell Sheet: Autonomously Functioning Bioengineered Tissue
Isolated cells (Used in conventional regenerative
medicine and cell therapy)
● Isolated cells not functioning as tissue
● Lost “extra-cellular matrix”
1. Functioning as a basic unit of biological tissue/organ• Low safety risk• Immediately becomes part of the
body
2. Extra-cellular matrix preserved
• Graft possible with no sutures• Remains and continues to produce
factors that aid tissue regeneration over the long term
3. Multiple layering possible= 3D tissues/organs construction possible
Cell Sheet
● Very difficult to construct 3D tissues/organs
Copyright © 2015 CellSeed Inc. All Rights Reserved.
Cell Sheet Regenerative Medicine Pipelines
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角膜
Prioritized business for 2015
•Epithelial cell sheet for
esophageal regeneration
•Regenerated cartilage sheet
Promote our own
development
• Cell Sheet for periodontal
tissue generation sheet
Explore possibility for
joint development
•Epithelial cell sheet for
corneal regeneration
•Regenerated cardiac patch
Explore cooperation
with partner(s)
Starting clinical trial sponsored by CellSeed
Copyright © 2015 CellSeed Inc. All Rights Reserved.
Treatment method to prevent esophageal stricture after removal of esophageal epithelial cancer developed by Tokyo Women’s University
Transplant the cultured autologous oral mucosal epithelial cell sheet in the intelligent cultureware on the ulceration after endoscopic surgery
CellSeed develops devices for transplanting cell sheets
Cell Sheet Regenerative MedicineEpithelial cell-sheet for esophageal regeneration
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Copyright © 2015 CellSeed Inc. All Rights Reserved. 7
Clinical development of epithelial cell sheet for esophageal regeneration
Japan CellSeed
Tokyo Women’s Medical University
Europe
Japan: Tokyo Women’s Medical University 20 patients
Sweden:Karolinska University Hospital 10 patients
Clinical research in academia
Company sponsored clinical trial
Copyright © 2015 CellSeed Inc. All Rights Reserved.
Establishment of a subsidiary in Sweden
Company name: CellSeed Sweden AB
Establishment:May 6, 2015
Location: Vollmervägen 12, SE-187 36 Täby, Sweden
Business:Cell-sheet regenerative medicine products in Europe
Capital: 6,800,000 SEK
Chairman of the board: Setsuko Hashimoto, Ph.D.
Board members : Erik Walden, Helena Nilshans
Country Manager: Camilla Huse Bondesson
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Promoting epithelial cell sheet for esophageal regeneration business in Europe
Copyright © 2015 CellSeed Inc. All Rights Reserved.
Cell sheet regenerative medicine for Regenerated cartilage sheet
In collaboration with Prof. Masato Sato, MD, Ph.D., Dept. of Orthopedic Surgery, Tokai University
Completed pilot clinical research with autologous cells with 8 patients (2011 – 2014)To start clinical trial in 2016 in Japan
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Multi-layered cell sheetsRegeneration of cartilage
3D tissues/organs construction
Prevent proteoglycan to diffuseProtect from catabolic factorsSources of growth factor secretion
“cell sheet” consisting of intact cellswith extra-cellular matrix
Multi-layered
Indication: cartilage defect, knee osteoarthritis
Copyright © 2015 CellSeed Inc. All Rights Reserved.
CellSeed business based on cell sheet engineering Covering all value chain of regenerative medicine business
Culture cell sheetTreatment with
regenerative medicine
Production & delivery of cell sheet
Regenerative medicine
Culture cells
Intelligence culatureware
Body cells・Stem cellsiPS cells
Temperature-responsive cell culatureware
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Copyright © 2015 CellSeed Inc. All Rights Reserved.
This presentation material has been prepared by CellSeed Inc. for information purposes only. Copyright
2014 CellSeed Inc. All rights reserved.
The information and opinions contained in this material have been obtained from sources believed to be
reliable, but no representations or warranties, express or implied, are made that such information is
accurate or complete and no responsibility or liability can be accepted by CellSeed for errors or omissions
or for any losses arising from the use of this material.
This information also contains forward-looking statements concerned with plans, strategies and forecasts
on future business performance of CellSeed group. CellSeed wishes to alert readers that such statements
involve risks and uncertainties, including, without limitation, risks inherent in the development and
commercialization of potential products, reliance on collaborators, need for additional capital, uncertainty
of clinical trial results or regulatory approvals or clearances, maintenance of our intellectual property rights,
changes in the business and economic environment and other factors. Actual results may differ materially
from the results anticipated in these forward-looking statements. CellSeed disclaims any duty to update
information provided herein. No part of this material shall be reproduced or redistributed in any form or by
any means, electronic, mechanical, photocopying, recording or otherwise, without prior written permission
of CellSeed Inc.
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Thank you for your attention.
Contact : Setsuko Hashimoto, Ph.D., President & CEO,CellSeed Inc. shashimoto@cellseed.comhttp://www.cellseed.com
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