What Metcela does

Metcela Inc. (株式会社メトセラ) is a clinical-stage Japanese biotechnology company founded in 2016 as a Keio University spin-off and headquartered at King Skyfront in Kawasaki. The company develops autologous cell therapies for cardiovascular disease, with two principal programs: JRM-001, an autologous cardiac stem cell (CSC) therapy for pediatric patients with functional single ventricle (currently in Phase 3 after resuming in January 2025), and MTC001, an autologous VCAM-1-positive cardiac fibroblast (VCF) therapy combined with a dedicated catheter delivery system for adult chronic ischemic heart failure (Phase 1 initiated 2021 at University of Tsukuba; development halted in 2024 due to investigational product supply challenges).

The company's core technology rests on two autologous cell populations: CSCs sourced from cardiac tissue and patented by Kyoto University (licensed exclusively to Metcela), and VCFs, a fibroblast subpopulation discovered by co-founder Takahiro Iwamiya that promotes cardiac lymphangiogenesis and cardiomyocyte proliferation. Both products are patient-derived (autologous) and cardiac-derived (homologous), which the company positions as enabling administration without immunosuppression. Metcela holds granted patents including Japanese Patent No. 6618066 covering VCF production and use, with PCT filings in the US, Europe, and Asia. JRM-001 has been granted both SAKIGAKE Designation and Orphan Regenerative Medicine Product status from Japan's Ministry of Health, Labour and Welfare.

Metcela's business model is structured around future commercialization of approved autologous cell therapy products to medical institutions in Japan, distributed through direct enterprise sales to hospitals and academic medical centers that administer the treatments. The company has no current product revenue; cumulative funding since inception totals approximately JPY 4.6 billion ($35M) including grants, drawn from venture capital (UTEC, Eight Roads Ventures, F-Prime, Sony Innovation Fund, Beyond Next Ventures), strategic corporate investors (CYBERDYNE, Japan Lifeline, Alfresa, Dai-ichi Life), and government grants (NEDO, AMED). Strategic and operational partnerships span Okayama University, University of Tsukuba, Nagoya University, Japan Lifeline (catheter co-development), and Japan Tissue Engineering (commercial manufacturing). Leadership transitioned in July 2024 with Kohtaro Toda assuming the CEO role from co-founders Iwamiya and Nogami.

Name

Metcela

Legal name

Metcela Inc.

Website

https://metcela.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

Metcela is a clinical-stage Japanese biotech developing autologous cell therapies (JRM-001 for pediatric single ventricle and MTC001 for adult heart failure) using cardiac stem cells and VCAM-1-positive cardiac fibroblasts, with products targeting Japanese regulators under SAKIGAKE designation.

Ownership category

akta.pro rank

Product category

Regenerative Medicine / Cell Therapy

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Surgical and Medical Instrument Manufacturing (339112)

SIC

Biological Products, (No Disgnostic Substances) (2836), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

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

akta.pro secondary industries

Cardiovascular & Vascular Regeneration (vascular grafts, angiogenesis) (HLAAAGAJ), Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL)

Keywords

• Regenerative medicine
• Autologous cell therapy
• Cardiac fibroblast therapy
• Heart failure treatment
• Cell processing services

Headquarters

HQ city

Kawasaki

HQ country

Japan

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Autologous Cell Therapy Products: Metcela develops and commercializes autologous cell therapy products (JRM-001 for pediatric single ventricle, MTC001 for adult chronic heart failure). Revenue will be generated through product sales to medical institutions upon regulatory approval.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Metcela develops and manufactures autologous regenerative cell therapy products for cardiovascular diseases, including JRM-001 (cardiac stem cell therapy for pediatric single ventricle patients) and MTC001 (VCAM-1-positive cardiac fibroblast therapy combined with a dedicated catheter delivery system for adult chronic heart failure). Products are manufactured at the company's cell processing facility in Kawasaki and supplied to hospitals and clinical trial sites in Japan.

Product overview

Metcela is a clinical-stage biotechnology company developing autologous cell therapies for cardiovascular diseases. The company operates two main product pipelines: JRM-001, an autologous cardiac stem cell therapy for pediatric single ventricle patients currently in Phase 3 clinical trials, and MTC001, an autologous VCAM-1-positive cardiac fibroblast (VCF) therapy combined with a dedicated catheter delivery system for adult chronic heart failure (Phase 1 initiated but development halted in 2024). Both products use the patient's own cells to avoid immune rejection, representing a platform of minimally invasive, tissue-specific regenerative medicine products.

Differentiator

Problem solved

Functional benefit

Products and services

• JRM-001 Autologous cell therapy product composed of cardiac stem cells (CSCs) for treating pediatric patients with functional single ventricle. Cardiac tissue is collected during standard surgery, CSCs are cultured at the cell processing facility, and the product is administered back via intracoronary injection during routine cardiac catheter examination. JRM-001 is the first regenerative medicine product in Japan designated under the SAKIGAKE Designation System and as an Orphan Regenerative Medicine Product.
• MTC001 Autologous cell therapy combining VCAM-1-positive cardiac fibroblasts (VCFs) with a dedicated catheter delivery system for treatment of adult chronic ischemic heart failure. Delivered via minimally invasive catheter-based transendocardial injection, reducing patient burden compared to open chest surgery.
• VCF Catheter Delivery System Specialized catheter system co-developed with Japan Lifeline for transendocardial injection of VCF cells into myocardial tissue, equipped with a highly functional injection needle for reliable and safe cell administration. Connects to commercially available 3D electroanatomical mapping systems for precision targeting of lesion sites.

Quantifiable outcome

• Phase 1 (TICAP) and Phase 2 (PERSEUS) clinical studies demonstrated safety and long-term efficacy of cardiac stem cells for single ventricle at Okayama University
• +2 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature4 records

Partnerships

Seven partnerships are on record, tiered core and major.

• Okayama UniversitycoreStrategic or Co-development PartnerCollaboration with Okayama University Hospital for clinical development of JRM-001. Phase 1 (TICAP) and Phase 2 (PERSEUS) clinical studies conducted by research team at Okayama University. Metcela acquired exclusive license and technical guidance from Okayama University on CSC manufacturing methods and clinical applications.
• Japan Lifeline Co., Ltd.coreStrategic or Co-development PartnerBusiness partnership agreement signed June 2020 for co-development and commercialization of MTC001 cell therapy product combining VCF with specialized catheter. Japan Lifeline developing catheter delivery system while Metcela provides cell product. Japan Lifeline is also an investor in Series B and Series C rounds.
• University of TsukubacoreStrategic or Co-development PartnerJoint research agreement for VCF development since 2017. Investigator-initiated Phase 1 clinical trial of MTC001 conducted at University of Tsukuba Hospital. Collaboration with Tsukuba Clinical Research & Development Organization (T-CReReDO).
• Nagoya UniversitycoreStrategic or Co-development PartnerIndustry-Academia Collaborative Chair established September 2023 for development of fibroblast-based pipelines in cardiovascular and respiratory diseases. Researchers stationed at Nagoya University as specially-appointed faculty. Joint research with Professor Toyoaki Murohara on mechanism of action of fibroblasts.
• Japan Tissue Engineering Co., Ltd.majorStrategic or Co-development PartnerManufacturing agreement signed for reliable production of JRM-001 autologous regenerative therapy. Japan Tissue Engineering is a pioneering regenerative medicine company with the most commercialized regenerative medicine products in Japan.
• Japan Regenerative Medicine Co., Ltd. (JRM)coreStrategic or Co-development PartnerAcquired April 2022 as wholly owned subsidiary, merged June 2022. JRM developed JRM-001 for pediatric congenital heart disease. Acquisition added pediatric autologous cell product to pipeline and strengthened clinical development infrastructure. Key team members including Kohtaro Toda continued development leadership.
• Kidswell Bio Co., Ltd.majorStrategic or Co-development PartnerFormer parent company of Japan Regenerative Medicine Co., Ltd. Business alliance established January 2022. Metcela allocated new shares to Kidswell Bio as part of acquisition agreement for JRM.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• Pluristem Therapeutics: Israel-based cell therapy company developing placenta-derived cell therapies for multiple indications including cardiovascular. Comparable as an emerging cell therapy player, though using allogeneic rather than autologous platform.

Broad incumbents

• Terumo Corporation: Major Japanese medical device manufacturer with extensive cardiac and cardiovascular product portfolio including catheters and interventional devices. Comparable as an established Japanese medtech incumbent with overlapping catheter delivery and cardiac therapy capabilities.
• Japan Tissue Engineering Co., Ltd. (J-TEC): Japan's leading regenerative medicine company with the most commercialized cell therapy products in Japan, including autologous cultured epidermis and cartilage. Comparable as a broader regenerative medicine incumbent that also serves as Metcela's manufacturing partner for JRM-001.
• Daiichi Sankyo Co., Ltd. Large Japanese pharmaceutical company with cardiovascular franchise and growing investment in cell and gene therapies. Comparable as a broad incumbent in cardiovascular therapeutics with potential strategic interest in cell therapy platforms.

Direct peers

• Capricor Therapeutics: US clinical-stage biotech developing CAP-1002, a cell therapy for Duchenne muscular dystrophy-associated cardiomyopathy and other cardiac conditions. Direct peer in cardiac cell therapy with proprietary cell-based platform.
• Mesoblast Limited: Australia/US-listed cell therapy company with REVASCOR for chronic heart failure using mesenchymal precursor cells. Direct peer in autologous/allogeneic cell therapy for cardiac indications at advanced clinical stage.
• Heartseed Inc. Japan-based clinical-stage cell therapy company developing HS-001, an iPSC-derived cardiomyocyte therapy for heart failure. Directly comparable as a Japanese cardiac cell therapy peer at similar clinical stage with autologous/allogeneic cell platform.
• BioCardia, Inc. US clinical-stage cell therapy company developing autologous cell therapies for heart failure delivered via catheter-based systems. Comparable for its cardiac cell therapy plus catheter combination product approach mirroring Metcela's MTC001 strategy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/metcelainc
• LinkedInlinkedin.com/company/metcela-inc

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Subsidiaries2 records

Funding overview

Funding rounds5 records

Investors15 records

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M&A1 record

Investments

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Frequently asked questions about Metcela