The stem cell culture room at Omotesando Helene Clinic is operated under the following strict hygiene controls: ISO Class 5 (Class 100) clean air is supplied to the clean bench, keeping the interior clean.
To grow and manage cells, the Cell Processing Center (CPC) must meet extremely high standards for reducing the number of particles and creating a sterile, bacteria-free room. To ensure a high level of safety, virus testing is also conducted when cells are received.
Furthermore, we have established a cell culture operation management system that incorporates a strict quality control system, including barcode management (traceability system) to prevent sample errors and history management of all processes.
Omotesando Helene Clinic has appointed Dr. Ravindra Gupta, Professor of Microbiology and Infectious Diseases at the Faculty of Medicine, University of Cambridge, as its technical advisor.
Professor Gupta is a world-renowned infectious disease researcher, and he incorporates the latest findings in the fields of stem cells and regenerative medicine into our hospital's culture techniques and quality control system.
Our clinic has both a clinic and a stem cell culture room, where stem cells collected from the body are grown in the culture room until they reach the quantity and quality suitable for treatment and research.
At Omotesando Helene Clinic, we focus on mesenchymal stem cells (MSCs) and aim to safely grow them while maintaining their undifferentiated state and functionality. We optimize the culture medium and culture conditions according to the properties and purpose of the cells, and supply cells that can withstand clinical application.
In the cultivation room, clean benches and clean rooms are used to thoroughly eliminate microbial contamination from outside, and workers wear dust-free clothing, disinfect their hands, and wipe equipment with alcohol before entering the room. After work is completed, equipment is sterilized with UV light to maintain a constantly clean environment. Furthermore, unique contamination risk reduction measures such as the "minimum exposure principle" and "two-stage cleaning" have been introduced to ensure both safety and quality.
Everything from cell culture, cell banking, and quality control is done in-house. By visualizing the culture process, patients can receive treatment with peace of mind.
Omotesando Helene Clinic has an in-house stem cell culture room and has undergone inspection by a third-party organization to issue a stem cell quality certificate, and has certified safety and quality through Takara Bio's GMP and regenerative medicine GLP inspections.
Using HELENE Medium and our proprietary technology, we are able to culture up to 2.25 billion MSCs within one month, enabling our clinic to provide 2.25 billion stem cell therapy.
The Omotesando Helene Clinic's culture room complies with the structural and facility standards and compliance requirements set forth by the Ministry of Health, Labor and Welfare of Japan, and is operated under a standardized, unified process from facility design to work procedures and record management. A notification for the manufacture of specific cell processed products has also been submitted, ensuring the provision of safe and effective stem cells under a legally compliant system.
In addition, high-performance equipment that meets international standards is used in each cultivation process, and all equipment undergoes regular inspection and calibration in accordance with the ISO9001 quality management system.
This allows us to maintain a safe and highly reproducible cell culture environment.
The culture room at Omotesando Helene Clinic is fully compliant with the manufacturing standards for "specific cell processed products" set by the Ministry of Health, Labor and Welfare of Japan.
Every step of the manufacturing process is standardized, from facility design to work procedures and record keeping.
Furthermore, we have submitted a notification of the manufacture of specific cell processed products and are operating under a legal compliance system.
This system ensures the safety and efficacy of the stem cells we provide to patients.
Each cultivation process uses high-performance equipment that meets international standards. All equipment undergoes regular inspection and calibration based on the ISO9001 quality management system to ensure safety and reproducibility.
Omotesando Helene Clinic has received an international quality award from the European Society for Quality Research (ESQR) in recognition of its high quality control system and safety initiatives in the fields of stem cell culture and regenerative medicine. This award is proof that our clinic's sterility control, strict process management, compliance with laws and regulations, and stem cell supply system that can withstand clinical application are recognized by international standards.
We have been officially appointed to the Japanese branch of the American Society for Regenerative Medicine (ASRM). As a result, we will share the latest research results and technical information through an international academic network, and further contribute to the development of regenerative medicine and the promotion of its clinical application in Japan.
All processes are carried out in a sterile environment using a clean bench in accordance with the standards for specific cell processing set by the Ministry of Health, Labor and Welfare of Japan. Safety and quality are ensured through strict procedures and record management for medium changes and subcultures.
Stable culture in an incubator that maintains 37°C, 5% CO₂, and humidity of 90% or more. Equipped with UV sterilization and HEPA, "one batch, one incubator" prevents cross-contamination.
Evaluate MSC adhesion, morphology, proliferation, and signs of contamination. Confirm nuclear staining such as DAPI and marker expression using an inverted phase contrast and fluorescence microscope.
Achieve early detection with standard recording format.
Centrifuge at low temperature (approximately 4°C) using MDX-310.
Pre-temp pre-cooling and soft braking minimize damage. Temperature, rotation speed, and time are standardized in SOP to maintain separation quality and activity.
Improve the purity of MSCs (CD73+/CD90+/CD105+, etc.). Animal-derived component-free beads are used, and antibody concentration, time, and temperature are standardized to ensure safety and traceability.
Cell count and viability were assessed using an automated counter at three time points (after isolation, after passaging, and before and after commercialization).
Quality and reproducibility are guaranteed based on a survival rate of 92% or higher.
NanoSight analyzes particle size distribution, concentration, and zeta potential to evaluate secretory capacity and manufacturing process stability, strengthening the scientific basis for regenerative medicine.
Real-time qPCR detects gene expression and mycoplasma with high sensitivity. Evaluate quality and functionality using targets such as GAPDH and IL-10.
Endotoxin (<0.5EU/mL) and mycoplasma are measured as a final quality inspection. Safety is guaranteed through three-stage inspections (initial, intermediate, and final) and cross-checks by a third-party organization.
This GMP-grade medium is free of serum and animal-derived components. It maintains the morphology, undifferentiated state, and immunomodulatory ability of MSCs and is compatible with cells from multiple sources.
After slow cooling to -80°C in a DMSO-containing storage solution and a programmed freezer, the cells are stored for a long period in liquid nitrogen at -196°C. After thawing at 37°C, the DMSO is removed and the cells are managed in a multi-stage master/working cell bank.
Compliant with clinical GMP standards, the equipment is sterilized by high-pressure steam at 121°C for 20 minutes or 134°C for 5 minutes. A sterile environment is guaranteed through weekly environmental disinfection, bacterial testing, and record management.
| Consultation hours | 10:00～19:00 |
|---|---|
| Closed days | Wed/Sun |
| address | 〒107-0062 5-9-15 Minami Aoyama, Minato Ward, Tokyo Aoyama OHMOTO Building 3F |
| phone | 03-3400-2277 |