TWO Cells Co., Ltd.

TWO Cells Co., Ltd. (株式会社ツーセル) is a Japanese regenerative medicine bioventure headquartered in Minami-ku, Hiroshima City. It was established on 23 April 2003 as a spin-off from Hiroshima University, at a time when regenerative medicine was still little known in Japan. The company's stated mission is to contribute to world healthcare and human health through regenerative medicine, aspiring to be a "21st-century global company" guided by four pursuits: humanity (fighting disease), sociality (broad adoption in society), economy (contributing to healthcare economics), and internationality (being globally competitive). The company specializes in regenerative medicine technologies using mesenchymal stem cells (MSC), which can be harvested from adult bodies. Its core approach is to take MSCs, expand them outside the body, and transplant them into patients. TWO Cells operates a "centralized" regenerative medicine business model, alongside a culture medium (培地) business, and pursues a pipeline of regenerative medicine products. Its lead candidate is gMSC®1, a three-dimensional artificial tissue derived from allogeneic (donor) synovial mesenchymal stem cells, aimed at cartilage-related conditions. A Phase III clinical trial of gMSC®1 began in 2017; while it did not meet its primary endpoint, secondary endpoints including MRI-based imaging evaluation and arthroscopic visual assessment suggested efficacy in structural cartilage evaluation. The company continues development in consultation with Japan's PMDA. TWO Cells positions itself as a "value-creating company with an integrated R&D-M system," covering research, development, and marketing of MSC technologies in an integrated manner. Its priority therapeutic areas are "bone and cartilage," "cardiac muscle and blood vessels," and "nerves and brain." Beyond product development, the company has expanded into consulting services for the regenerative medicine industry, application of gMSC® technology to private-practice (self-pay) medical services, and continued efforts toward approval of the gMSC® series. The company's name and logo reflect its founding concept: "two cells" that gave rise to TWO Cells, symbolizing the infinite (∞) possibilities of medical technology and the hope it brings. TWO Cells is headquartered at the Otani Building, 1-6-10 Deshio, Minami-ku, Hiroshima, with capital of 100 million yen (as of 31 March 2025). It is led by Representative Director and President Masaya Matsumoto, with directors Moriichi Hasegawa and Minoru Tsukamoto, and accounting advisor Yosuke Yamane. The company maintains a Tokyo office, opened in 2006 in Bunkyo-ku, Tokyo. Its business scope covers research, development, manufacturing, and sales of medical genes and cells, pharmaceuticals, diagnostics, reagents, and medical materials; medical devices and instruments; diagnostic, therapeutic, and culture methods for genes and cells; and computer systems for regenerative medicine.

TWO Cells Co., Ltd. was established on 23 April 2003 in Minami-ku, Hiroshima City, as a venture company originating from Hiroshima University. The founding took place at a time when regenerative medicine was still not widely known in Japan, and the company has since spent more than two decades working toward the commercialization of regenerative medicine products using mesenchymal stem cells (MSC). In May 2005, TWO Cells concluded a development license agreement with DENTSPLY International Inc. (USA) for a periodontal disease treatment product. In January 2006, the company began sales of an automated stem cell culture apparatus. In April 2006, it opened a Tokyo office in Bunkyo-ku, Tokyo, extending its presence beyond Hiroshima. The company's flagship development candidate, gMSC®1, is a three-dimensional artificial tissue derived from allogeneic (donor) synovial mesenchymal stem cells. A Phase III clinical trial of gMSC®1 began in 2017. According to the company's president message, the trial did not meet its primary endpoint; however, secondary endpoints including MRI-based imaging evaluation and arthroscopic visual assessment suggested efficacy in structural cartilage evaluation. The company stated that continued consultation with the PMDA (Pharmaceuticals and Medical Devices Agency) and, if necessary, acquisition of new data may be required, and that the path to approval cannot be viewed optimistically. In response to this situation, TWO Cells has broadened its activities. It has pursued consulting services for the regenerative medicine industry leveraging knowledge and technology gained through development activities, application of gMSC® technology to private-practice (self-pay) medical services, and continued efforts toward approval of the gMSC® series. The company describes itself as aiming for self-sustaining management and growth while fulfilling its mission. As of 31 March 2025, the company's capital stood at 100 million yen. In March 2025, the company issued a notice regarding a reduction of its capital amount. The company files electronic public notices for its fiscal year results; its 22nd fiscal year covered 1 April 2024 to 31 March 2025, and its 23rd fiscal year covered 1 April 2025 to 31 March 2026. In December 2025, the company announced the passing of former Chairman Koichiro Tsuji, and in 2026 held a farewell gathering in his memory. The company has continued to present at academic meetings, including the Japanese Society for Regenerative Medicine and the Japanese Society for Cartilage Metabolism, and to exhibit at events such as the Japan Healthcare Venture Summit and TSUNAGU Hiroshima.

• Established as a Hiroshima University spin-off venture company in Minami-ku, Hiroshima City.

• Concluded a development license agreement with DENTSPLY International Inc. (USA) for a periodontal disease treatment product.

• Began sales of an automated stem cell culture apparatus.

• Opened a Tokyo office in Bunkyo-ku, Tokyo.

• Phase III clinical trial of gMSC®1 began.

• Issued a notice regarding reduction of capital amount.

• Electronic public notice of 22nd fiscal year financial results (1 April 2024 – 31 March 2025).

• Announced the passing of former Chairman Koichiro Tsuji.

• Electronic public notice of 23rd fiscal year financial results (1 April 2025 – 31 March 2026).

• Submitted clinical trial plan notification for Phase III trial of gMSC®1.

A Hiroshima University spin-off bioventure specializing in MSC-based regenerative medicine, aiming to be a value-creating company with an integrated research-development-marketing system for stem cell therapies.

• gMSC®1

  An allogeneic (donor) synovial mesenchymal stem cell-derived three-dimensional artificial tissue, the company's lead regenerative medicine candidate.

• Stem cell automated culture apparatus

  Automated equipment for culturing stem cells, sold since January 2006.

• Culture media

  Culture media business operated by the company.

1. 1株式会社ツーセル｜再生医療に取り組む広島を拠点としたバイオベンチャー企業twocells.com
2. 2会社情報｜株式会社ツーセルtwocells.com
3. 3TWO Cells Co., Ltd. (Japan) - Wikidatawikidata.org
4. 4会社情報｜株式会社ツーセルtwocells.com
5. 5会社情報｜株式会社ツーセルtwocells.com