Hitachi Provides and Launches Regenerative Medicine Value Chain Integrated Management Platform for CellSeed's Clinical Trials

Overview of the Solution

Hitachi, Ltd. (hereinafter 'Hitachi') has provided the 'Hitachi Value Chain Traceability service for Regenerative Medicine' (hereinafter 'HVCT RM'), an integrated value chain management platform for regenerative medicine products, to CellSeed Inc. (hereinafter 'CellSeed'), a bio-venture developing 'cell sheets' that create tissue from cells, and commenced its operation in April 2026. HVCT RM, a Lumada*1 solution, is an integrated management platform that supports the optimization of the entire supply chain for regenerative medicine products, from cell collection to production, transport, and administration. On this occasion, it was provided for the clinical trials (Phase 3 trials*2) conducted by CellSeed for the commercialization of allogeneic cartilage cell sheets*3. For the first time, a new 'Resource Reservation Management Function' (hereinafter 'this function') has been implemented to streamline schedule adjustments for the shipment of regenerative medicine products. This allows the manufacturing company of regenerative medicine products to create and publish available reservation slots based on information such as the availability of manufacturing lines for cell cultivation and processing, enabling medical institutions to easily select and reserve their preferred dates from the candidate options. Moving forward, Hitachi will actively deploy HVCT RM as a data collection and accumulation foundation supporting 'HMAX Industry'.

CellSeed is a leading bio-venture in regenerative medicine, utilizing technology to create tissue from cells. Its strength lies in its proprietary 'cell sheet engineering,' which maintains cell-to-cell junctions while retrieving them in sheet form. 'Cell sheet engineering' uses temperature-responsive cell cultureware to harvest cells as a sheet. Using cell sheets created with this technology, CellSeed is striving to realize novel medical treatments that repair tissues and organs difficult to treat with conventional pharmacotherapy, aiming to contribute to patients' healthy lives.

Currently, CellSeed is advancing efforts toward the clinical application of 'allogeneic cartilage cell sheets' to repair damaged knee joint cartilage in patients with knee osteoarthritis. Furthermore, as part of its regenerative medicine contract manufacturing services, CellSeed currently manufactures cell sheets for 'esophageal regenerated epithelial sheets' aimed at preventing strictures after endoscopic surgery for esophageal cancer led by medical institutions, and 'autologous cartilage regeneration sheets' using the patients' own cells for treating knee osteoarthritis. Additionally, it develops and sells 'temperature-responsive cell cultureware' that allows cells to be detached without damage simply by changing the temperature, providing technical support to researchers worldwide.

In the pharmaceutical and regenerative medicine fields, the Hitachi Group contributes to solving issues across the entire value chain. Alongside HVCT RM, it offers 'HITPHAMS,' a manufacturing and quality control system with a top-tier track record in Japan for the pharmaceutical and medical device manufacturing industries, as well as a wide range of products including cell culture processing facilities, automated cell culture systems, regenerative medicine cabinets, and rapid microbial testing systems. These latest technologies from the Hitachi Group are showcased at showrooms in 'Nakanoshima Qross' (Osaka City, Osaka), an international hub for future medicine, and the 'Regenerative Medicine Innovation Center' (Chuo-ku, Tokyo).

For the industrial sector, Hitachi is focusing on 'HMAX Industry,' a suite of next-generation solutions that combine domain knowledge and advanced AI with the rich installed base (digitalized assets) data of its products. Through the provision of these core 'Industrial Solutions,' Hitachi aims to maximize customer lifetime value and transform industries globally, striving to realize a prosperous society.

*1 Lumada: A collective term for solutions, services, and technologies utilizing Hitachi's advanced digital technology to create value from customer data and accelerate digital innovation.

*2 Allogeneic cartilage cell sheets: Sheets produced by cultivating and processing cartilage cells from healthy individuals (donors).

*3 Phase 3 trial: The final stage of clinical trials involving a large number of patients, confirming the ultimate efficacy and safety of a new drug by comparing it to existing standard treatments or a placebo.

Features and Benefits of This Implementation

1. First Implementation of the 'Resource Reservation Management Function': Ensuring Reliable Schedule Adjustments and Reducing Man-Hours

This time, the 'Resource Reservation Management Function' has been implemented as a new feature of HVCT RM for the first time. By simply registering available shipping slots based on its manufacturing status, CellSeed's candidate administration dates are automatically planned and published to medical institutions. Medical institutions then select and enter their preferred date from the presented slots, completing the reservation.