TWO CELLS

What TWO CELLS does

TWO CELLS (株式会社ツーセル) is a Hiroshima University spin-off founded in April 2003 that develops allogeneic mesenchymal stem cell (MSC)-based regenerative medicine products and proprietary serum-free cell culture media. Its lead asset, gMSC®1, is an allogeneic synovial MSC-derived three-dimensional tissue construct (TEC technology) for knee cartilage regeneration that has completed a 70-patient Phase III comparative clinical trial in Japan; the primary endpoint was not met but secondary MRI and arthroscopic endpoints suggested structural efficacy. The pipeline extends to gMSC®2 (cerebral infarction), gMSC®3 (early-stage knee osteoarthritis), gMSC®4 (chronic kidney disease), and gMSC®1-A (autologous free-market variant). The company also sells the STK® series of chemically defined serum-free MSC culture media (STK-1 primary culture, STK-2 expansion, STK-3 osteogenic differentiation) via distributor Kanto Chemical Co., Ltd., and provides regenerative medicine consulting services.

TWO CELLS operates a hybrid business model combining pharmaceutical licensing with direct free-market provision. Under the June 2025 license agreement with Kaken Pharmaceutical Co., Ltd. (科研製薬), TWO CELLS granted exclusive Japan orthopedic development and sales rights for gMSC-1 in exchange for upfront fees, development milestones, and royalties potentially totaling approximately 7 billion yen; this replaced the terminated April 2023 Chugai Pharmaceutical license. A parallel February 2024 license to Kohjin Bio Co., Ltd. covers the autologous gMSC-1-A variant under Japan's Regenerative Medicine Safety Act, enabling free-market treatment at partner medical institutions — the first of which began providing knee cartilage regeneration therapy from April 2025. A December 2023 strategic partnership with HESTA Okura Co., Ltd. targets integration into a smart-city preventive healthcare platform. Customers and partners include Kaken Pharmaceutical, Kohjin Bio, HESTA Okura, Kanto Chemical, Hiroshima University, and Osaka University. The company is headquartered in Hiroshima, Japan, employs 11-50 people, and has a registered capital of 1 billion yen as of March 2025 following multiple capital reductions in 2023-2025 to eliminate accumulated deficit.

Name

TWO CELLS

Legal name

株式会社ツーセル

Website

https://twocells.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

11–50 employees

Short description

TWO CELLS is a Hiroshima University spin-off developing allogeneic mesenchymal stem cell (MSC) regenerative medicine products and serum-free culture media, including lead asset gMSC®1 for knee cartilage regeneration licensed to Kaken Pharmaceutical in Japan.

Ownership category

akta.pro rank

Product category

Regenerative Medicine

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro industry

PRIMARYHLAAABAE

Stem Cell Therapies (MSC/iPSC/HSC-derived)

Healthcare & Life Sciences/Biotechnology & Biologics/Cell Therapy (autologous/allogeneic)

SECONDARYHLAAAGAH

Cartilage, Bone & Musculoskeletal Regeneration

Healthcare & Life Sciences/Biotechnology & Biologics/Regenerative Medicine & Tissue Engineering

SECONDARYHLAAABAB

Cell Therapy Developers (Allogeneic/Off-the-shelf)

Healthcare & Life Sciences/Biotechnology & Biologics/Cell Therapy (autologous/allogeneic)

SECONDARYHLAAAKAC

Cell Therapy Manufacturing Services (GMP, autologous/allogeneic)

Healthcare & Life Sciences/Biotechnology & Biologics/Biomanufacturing Services

Keywords

• Regenerative medicine products
• Mesenchymal stem cell therapy
• Serum-free culture media
• Allogeneic cell therapy
• Cartilage regeneration therapy

Headquarters

HQ city

Hiroshima

HQ country

Japan

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Licensing and Milestone Payments: TWO CELLS receives upfront licensing fees, development milestone payments, and post-approval royalties from pharmaceutical partners. Under the June 2025 Kaken Pharmaceutical agreement, the company is entitled to an upfront signing fee, development milestone payments, and sales-based royalties up to approximately 7 billion yen in total potential deal value.
2. Regenerative Medicine Product Sales: Revenue from the sale of regenerative medicine products and related cellular therapies. The company is expanding into the free-market (自由診療) segment, with the first partner medical institution beginning knee cartilage regeneration treatment from April 2025.
3. STK Series Serum-Free Media Sales: Sale of proprietary MSC serum-free culture media products (STK-1, STK-2, STK-3) for research and clinical applications. Distributed through sales agent Kanto Chemical Co., Ltd. (関東化学株式会社).
4. Stem Cell Auto-Culture Device Sales: Sale of automated stem cell culture equipment, which began in January 2006.
5. Regenerative Medicine Consulting Services: Consulting services leveraging the company's accumulated knowledge and technology in regenerative medicine development, manufacturing, and quality control.

Pricing tiers

Go-to-market motion1 record

Distribution channels5 records

Marketing channels6 records

Core offering

TWO CELLS develops and supplies mesenchymal stem cell (MSC)-based regenerative medicine products and proprietary serum-free cell culture media. Its core product gMSC-1 is an allogeneic synovial MSC-derived three-dimensional artificial tissue for knee cartilage regeneration, licensed to Kaken Pharmaceutical for joint development and exclusive sales in Japan. The company also sells the STK series (STK-1, STK-2, STK-3) of chemically defined serum-free culture media through distributor Kanto Chemical, and provides regenerative medicine consulting services to industry partners.

Product overview

TWO CELLS is a regenerative medicine venture company developing MSC (mesenchymal stem cell)-based therapies and cell culture products. The product portfolio consists of two main lines: (1) gMSC® series regenerative medicine products including gMSC®1 for knee cartilage injury (Phase III completed), gMSC®2 for cerebral infarction, gMSC®3 for osteoarthritis, and gMSC®4 for chronic kidney disease; and (2) STK® series serum-free culture media for MSC research and clinical applications (STK®1 for primary culture, STK®2 for mass expansion, STK®3 for osteogenic differentiation). The company operates a Central-type regenerative medicine business model using allogeneic (donor-derived) cells that can be stocked and used immediately without patient tissue collection.

Differentiator

Problem solved

Functional benefit

Brands

• gMSC: Guaranteed MSC - a brand name for the company's allogeneic mesenchymal stem cell products, including gMSC-1 for knee cartilage regeneration and gMSC-2 for cerebral infarction treatment.
• STK
• TEC

Products and services

• gMSC®1

Quantifiable outcome

• Over 1000x growth rate compared to conventional serum-supplemented MSC culture media
• +4 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Seven partnerships are on record, tiered flagship, core and historical.

• Kaken Pharmaceutical Co., Ltd. (科研製薬株式会社)flagshipOEM/ Whitelabel/ Licensing Partner · 2 June 2025TWO CELLS granted Kaken Pharmaceutical exclusive rights for joint development and exclusive sales of allogeneic synovial MSC-derived 3D artificial tissue product gMSC-1 in Japan's orthopedic field. Kaken receives development and exclusive sales rights in exchange for upfront signing fee, development cost contributions, development and sales milestone payments up to approximately 70 billion yen, and ongoing royalties on sales. This replaced the terminated 2016 Chugai Pharmaceutical license (which ended April 2023).
• Kojin Bio Co., Ltd. (コージンバイオ株式会社)coreChannel Partner/ Reseller/ Distributor · 14 February 2024TWO CELLS licensed gMSC-1-A manufacturing rights to Kojin Bio under the Regenerative Medicine Safety Act for autologous transplantation at medical institutions. Kojin Bio acts as a specific cellular processed product manufacturer for free-market treatments. TWO CELLS receives signing fees and royalties.
• HESTA Okura Co., Ltd. (株式会社HESTA大倉)coreStrategic or Co-development Partner · 22 December 2023Strategic business partnership combining HESTA Okura's smart city / preventive healthcare platform (HESTA Healthcare) with TWO CELLS' MSC culture and quality control technologies. Goal is to deliver both prevention and treatment solutions in the regenerative medicine space. HESTA Okura focuses on lifestyle and healthcare integration in regional cities.
• Hiroshima University Stem Cell Applied Medical Science Joint Research Department (広島大学 幹細胞応用医科学共同研究講座)coreStrategic or Co-development Partner · 26 April 2021Joint research partnership with Hiroshima University on renal fibrosis suppression therapy using mesenchymal stem cells cultured in serum-free medium. Research project led by Professor Nakajima Ayumu was selected for AMED Regenerative Medicine Practical Application Research Program (令和3年度 再生医療実用化研究事業). TWO CELLS supports cell processing methods and overall R&D as a joint research partner.
• Chugai Pharmaceutical Co., Ltd. (中外製薬株式会社)historicalOEM/ Whitelabel/ Licensing Partner · 1 April 2016License agreement for knee cartilage regenerative cell therapy product gMSC-1, entered April 2016. This license was terminated in April 2023, as announced by TWO CELLS. The termination led to the subsequent Kaken Pharmaceutical agreement in June 2025.
• Osaka University (大阪大学)coreStrategic or Co-development Partner · 1 January 2014TWO CELLS collaborated with Osaka University on TEC (Tissue-Engineered Construct) technology development. Osaka University clinical research confirmed the safety and efficacy of TEC in human subjects. The research data (Kazunori S., Norimasa N. et al., Am J Sports Medicine 2018) underpinned gMSC-1 development. In August 2015, Osaka University established an MSC Cell Bank as an outcome of joint research with TWO CELLS.
• DENTSPLY International Inc. (米国)historicalStrategic or Co-development Partner · 1 May 2005License agreement for periodontal disease treatment product development signed May 2005 with US-based DENTSPLY International Inc.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• JCR Pharmaceuticals: Japanese specialty pharma with TEMCELL HS Inj., an approved allogeneic MSC product for acute GVHD, making it a direct domestic peer to TWO CELLS in commercial-stage MSC therapeutics and a natural commercialization benchmark.
• Healios K.K. Japan-based regenerative medicine company developing stem cell therapies (e.g., HLCM051 for stroke, stem cell treatments for ARDS) using somatic stem cells — closely comparable in geography, modality, and clinical-stage positioning.
• SanBio: Japanese regenerative medicine company developing allogeneic cell therapies (SB623) for neurological indications including stroke — directly comparable in MSC-derived allogeneic approach and Japan-centric clinical pipeline.
• Mesoblast: Global MSC therapy developer (Remestemcel-L for pediatric SR-aGVHD; REVASCOR for heart failure) — directly comparable in allogeneic MSC platform, multi-indication strategy, and late-stage clinical positioning.

Emerging players

• Cynata Therapeutics: Australian clinical-stage biotech using a unique MSC manufacturing platform (Cymerus) for inflammatory and orthopedic indications — comparable in allogeneic MSC platform technology but smaller and at earlier commercial stage.
• Pluristem Therapeutics: Israeli cell therapy company using placenta-derived MSC-like adherent stromal cells (PLX-PAD) for multiple indications including muscle injury and CLI — comparable allogeneic, off-the-shelf cell therapy approach.
• Athersys: US clinical-stage company developing MultiStem (multipotent adult progenitor cell) therapies for stroke, ARDS, and trauma — comparable in allogeneic, off-the-shelf cell therapy positioning, though it has faced clinical and financial headwinds.

Broad incumbents

• Rohto Pharmaceutical: Major Japanese pharma with a regenerative medicine business (e.g., corneal endothelial cell therapy) — a broader domestic incumbent in Japan's regenerative medicine ecosystem with greater resources but more diversified portfolio.
• Terumo Corporation: Japanese medical device and cell therapy company (through Terumo BCT and Cell Processing leadership) — relevant incumbent for cell processing, autologous cell therapy manufacturing infrastructure, and Japanese regenerative medicine commercialization.

Regional players

• CellSeed: Japanese regenerative medicine company focused on epithelial cell sheet engineering (e.g., corneal and esophageal applications) — comparable as a domestic Japanese cell therapy developer navigating PMDA regulatory pathways.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds5 records

Investors5 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about TWO CELLS