The Stem Cell Culture Laboratory at Omotesando HELENE Clinic operates under rigorous control and hygiene management. Inside the clean bench, ISO Class 5 (Class 100) clean air is supplied to maintain a sterile environment. To promote the growth and management of cells, our Cell Processing Center (CPC) maintains a highly sterile, bacteria-free space with significantly reduced particle counts. For enhanced safety, virus testing and other inspections are conducted upon cell intake. Furthermore, to prevent sample mix-ups, we implement barcode-based traceability systems and strict process history management, ensuring a robust quality management system for cell culture operations.
Omotesando HELENE Clinic has welcomed Dr. Ravindra Gupta, Professor of Microbiology and Infectious Diseases at the University of Cambridge School of Clinical Medicine, as Technical Advisor. Professor Gupta is a globally recognized researcher in infectious diseases and applies the latest knowledge in stem cells and regenerative medicine to enhance our culture techniques and quality control systems.
Our clinic houses both treatment facilities and a stem cell culture laboratory, enabling us to expand stem cells collected from the body to the quantity and quality suitable for treatment or research. At HELENE Clinic, we focus on mesenchymal stem cells (MSC), optimizing culture media and conditions to safely expand them while preserving their undifferentiated state and function. Our clean benches and clean rooms completely eliminate external microbial contamination. Before entering the lab, staff wear dust-free garments, perform hand disinfection, and wipe instruments with alcohol. At the end of operations, we use UV sterilization to maintain a clean environment. We also implement original contamination risk reduction measures such as the “Minimum Exposure Principle” and “Two-Stage Cleaning,” balancing safety with quality.
From cell culture and cell banking to quality control, all processes are carried out in-house. Process visualization allows patients to receive treatment with confidence.
Following both in-house CPC and third-party testing, we issue a Stem Cell Quality Certificate. Safety and quality are verified through GMP and regenerative medicine GLP testing by Takara Bio.
Using HELENE Medium and proprietary technology, we can culture up to 2 billion MSC within one month, making our 2-billion-cell treatments possible.
Our culture laboratory strictly adheres to the Japanese Ministry of Health, Labour and Welfare’s manufacturing standards for Specified Cell Products. From facility design to work procedures and record keeping, operations follow standardized, unified processes. We have filed the required manufacturing notification and operate under full legal compliance. All culture processes utilize high-performance equipment that meets international standards, with regular inspections and calibrations carried out under the ISO9001 Quality Management System, ensuring a highly safe and reproducible cell culture environment.
Our culture laboratory is fully compliant with Japan’s Ministry of Health, Labour and Welfare manufacturing standards for Specified Cell Products. From facility design to procedures and record keeping, all manufacturing steps are standardized. The required manufacturing notification has been filed, ensuring that stem cells provided to patients are safe and effective.
Each stage of the culture process uses high-performance equipment compliant with international standards. All devices undergo regular inspections and calibrations based on the ISO9001 Quality Management System, ensuring safety and reproducibility.
HELENE Clinic has been recognized by the European Society for Quality Research (ESQR) with an International Quality Award for its high standards in stem cell culture and regenerative medicine. This recognition affirms our sterile management, strict process control, regulatory compliance, and capacity to provide high-quality stem cells suitable for clinical application.
We have been officially appointed as the Japan Branch of the American Society for Regenerative Medicine (ASRM). This allows us to share the latest research findings and technical information through an international academic network, further contributing to the development and clinical application of regenerative medicine in Japan.
Conducted under sterile conditions in a clean bench in compliance with the Japanese MHLW standards for Specified Cell Products. Media changes and passaging follow strict SOPs and record management to ensure safety and quality.
Cultured in incubators maintained at 37°C, 5% CO₂, and over 90% humidity. UV sterilization, HEPA filtration, and “one batch per incubator” prevent cross-contamination.
Evaluating MSC adhesion, morphology, proliferation, and contamination signs. Using inverted phase contrast and fluorescence microscopy, with DAPI nuclear staining and marker expression verification. Early detection is ensured via standardized recording formats.
Low-temperature (~4°C) centrifugation with MDX-310. PRE-TEMP pre-cooling and Soft Brake minimize damage. Temperature, speed, and time are standardized in SOPs to maintain separation quality and viability.
Improving MSC purity (CD73+, CD90+, CD105+, etc.). Using xeno-free beads, with standardized antibody concentration, time, and temperature for safety and traceability.
Automatic counters assess cell number and viability at three points (post-separation, post-passage, pre/post productization). Quality and reproducibility are guaranteed with viability of 92% or higher.
NanoSight analyzes particle size distribution, concentration, and zeta potential. Evaluates secretion capacity and manufacturing stability, reinforcing scientific evidence for regenerative medicine.
Real-time qPCR detects gene expression and mycoplasma with high sensitivity. Targets such as GAPDH and IL-10 are used to evaluate quality and functionality.
Final quality testing measures endotoxins (<0.5 EU/mL) and mycoplasma. Initial, intermediate, and final tests, plus third-party cross-checking, ensure safety.
Serum-free, xeno-free, GMP-grade medium. Maintains MSC morphology, undifferentiated state, and immunomodulatory functions, compatible with cells from multiple sources.
After gradual cooling to −80°C with DMSO-containing cryoprotectant using a programmable freezer, cells are stored long-term in −196°C liquid nitrogen. Post-thaw DMSO removal and multi-tier master/working cell bank management ensure quality.
Following clinical GMP standards, high-pressure steam sterilization at 121°C for 20 minutes or 134°C for 5 minutes. Weekly environmental disinfection, microbial testing, and record management maintain sterility.
| Consultation hours | 10:00～19:00 |
|---|---|
| Closed days | Wednesday · Sunday |
| Address | 〒107-0062 5-9-15 Minami Aoyama, Minato-ku, Tokyo Aoyama OHMOTO Building 3F |
| Tel | 03-3400-2277 |