The in-house lab (CPC) at Helene Clinic operates under the most stringent standards, adhering to rigorous environmental and hygiene control protocols. Inside the clean benches, a continuous supply of ISO Class 5 (Class 100) purified air ensures a completely sterile and contamination-free environment for cell processing.
To safely expand and manage cellular materials, Cell Processing Centers (CPCs) must adhere to exceptionally high standards that minimize microparticulates, creating a strictly sterile environment completely free of microbial contamination. Furthermore, to guarantee the absolute highest level of safety, comprehensive viral screenings and rigorous testing are routinely conducted immediately upon cell arrival.
Furthermore, to completely eliminate the risk of sample mix-ups, we utilize an advanced barcode-driven traceability system alongside a rigorous quality control framework that seamlessly monitors and logs the complete history of every single stage in the cell culture process.
Omotesando Helene Clinic is privileged to welcome Dr. Ravindra Gupta, Professor of Clinical Microbiology at the University of Cambridge, as our technical advisor. As a world-renowned expert in infectious diseases, Professor Gupta integrates cutting-edge insights from the fields of stem cell research and regenerative medicine directly into our clinic’s cultivation techniques and quality control systems.
Helene clinic features an on-site in-house lab (CPC), allowing us to seamlessly expand stem cells harvested from the patients and process them to the precise quantity, quality required for advanced treatments and pioneering research. At Omotesando Helene Clinic, we place a primary focus on mesenchymal stem cells (MSCs), optimizing customized culture mediums and environmental conditions based on specific cellular profiles to safely proliferate cells while meticulously preserving their undifferentiated state and functionality, thereby supplying premium-grade cells perfectly suited for clinical applications.
Inside the in-house lab (CPC), we thoroughly eliminate external microbial contamination through the strategic utilization of clean benches and advanced cleanrooms. Before entry, technicians must don sterile cleanroom suits, perform rigorous hand disinfection, and sanitize all equipment with medical-grade alcohol. Upon the completion of procedures, the environment undergoes UV irradiation sterilization to maintain a consistently pristine and optimal state. Furthermore, we have integrated our own stringent contamination risk reduction measures, such as the "shortest exposure principle" and a "two-stage cleaning" protocol, to seamlessly achieve the highest standards of both safety and quality.
Every single phase of our
operations is fully completed
in-house.
Independent third-party
evaluations, verified by Takara Bio.
Up to 2.25 billion MSCs within one month cultivation.
The cultivation facility at Omotesando Helene Clinic complies with the rigorous standards mandated by the Japanese Ministry of Health, Labour and Welfare (MHLW), operating under a fully standardized, unified protocol. Having successfully acquired the
Notification for the Manufacture of Specific Cell-Processed Products, Helene deliver safe and highly effective stem cells under a robust legal compliance framework. Furthermore, each stage of our cultivation process utilizes high-performance machinery
conforming to strict international standards, with all equipment undergoing routine professional inspection and calibration in
strict accordance with the ISO 9001 Quality Management System. Through these rigorous protocols, we continuously maintain an exceptionally safe and highly reproducible environment for premier cell processing.
The in-house lab (CPC) at Omotesando Helene Clinic
complies with the manufacturing standards for "Specific
Cell-Processed Products" mandated by the Japanese
Ministry of Health, Labour and Welfare (MHLW). Every
single aspect of our operations—from facility architecture
and daily operational workflows to rigorous record
management—is thoroughly standardized, ensuring that all steps in the processing cycle are seamlessly unified.
Furthermore, we operate under a robust regulatory
framework, having successfully submitted the mandatory
Notification for the Manufacture of Specific Cell-Processed Products. Through this unwavering compliance system, we confidently guarantee the ultimate safety and maximum
therapeutic efficacy of the stem cells provided to our
patients.
Each stage of cultivation process utilizes advanced, high-
performance equipment that strictly conforms to
recognized international standards. To ensure absolute
safety and consistent reproducibility, all machinery
undergoes routine, rigorous inspections and professional
calibrations in strict accordance with the ISO 9001 Quality Management System.
Helene clinic has been honored with a prestigious international quality award from the European Society for Quality Research (ESQR), highly recognizing our exceptional quality control systems and unwavering commitment to safety within the fields of stem cell cultivation and regenerative medicine. This global accolade serves as definitive proof that our flawless sterile management, rigorous process controls, strict regulatory compliance, and premium stem cell supply infrastructure meet the highest international standards for clinical applications.
We are proud to announce our official appointment to the Japan Chapter of the American Board of Regenerative Medicine (ABRM). Through this global academic network, we will actively share the latest pioneering research breakthroughs and technical insights, further accelerating the advancement and clinical implementation of cutting-edge regenerative medicine within Japan.
Fully aligned with the strict standards for Specific Cell-Processed Products mandated by the Japanese Ministry of Health, Labour and Welfare (MHLW), every single step of our operation is conducted within a flawless sterile environment using advanced clean benches. We confidently guarantee absolute safety and premium quality by applying rigorous procedural protocols and meticulous record management to both routine culture medium changes and critical subculturing phases.
We achieve stable, high-fidelity cultivation by utilizing state-of-the-art incubators that flawlessly maintain optimal physiological conditions at 37°C, 5% CO₂, and over 90% humidity. To eliminate any risk of cross-contamination, our facilities feature built-in UV sterilization and advanced HEPA filtration, strictly operating under an uncompromised "one batch, one incubator" protocol.
We continuously evaluate the adhesion status, cellular morphology, proliferation rates, and any potential signs of contamination in our Mesenchymal Stem Cells (MSCs). Utilizing advanced inverted phase-contrast and fluorescence microscopy, our specialists precisely verify nuclear staining (such as DAPI) and specific surface marker expressions. By implementing standardized, highly detailed recording formats, we ensure the early detection of even the slightest cellular anomalies.
We conduct precise, low-temperature centrifugation (approximately 4°C) using the high-performance MDX-310 system. By leveraging advanced PRE-TEMP pre-cooling and a specialized Soft Brake function, we successfully minimize cellular stress and physical damage, while strictly standardizing temperature, rotation speed, and duration through our rigorous SOPs to consistently lock in premium separation quality and cellular viability.
We significantly enhance the targeted purity of our Mesenchymal Stem Cells (MSCs), verifying specific key markers such as CD73+, CD90+, and CD105+. By utilizing strictly xeno-free (animal-derived component-free) magnetic beads and fully standardizing our antibody concentrations, processing times, and temperatures, we absolute ensure unparalleled patient safety and complete sample traceability.
We utilize advanced automated counters to precisely evaluate both cell count and viability at three critical stages: post-isolation, post-subculturing, and immediately before and after final product preparation. By maintaining a rigorous benchmark of a 92% or higher viability rate, we confidently guarantee unmatched quality and consistent treatment reproducibility.
By leveraging advanced NanoSight technology, we perform meticulous analyses of particle size distribution, concentration, and zeta potential with absolute precision. This deep characterization allows us to rigorously evaluate the secretion capacity and long-term stability of our manufacturing processes, substantially strengthening the robust scientific foundation of our regenerative medicine therapies.
We leverage high-sensitivity real-time qPCR technology to guarantee the definitive detection of specific gene expressions and ensure absolute freedom from mycoplasma contamination. By precisely monitoring key molecular targets such as GAPDH and IL-10, we rigorously evaluate both the structural quality and therapeutic functionality of our cells.
As our definitive final quality control protocol, we perform ultra-precise testing to measure endotoxin levels (strictly keeping them below 0.5 EU/mL) and definitively confirm the absence of mycoplasma. Our absolute safety is unconditionally guaranteed through a rigorous three-stage inspection process—encompassing the initial, intermediate, and final phases—complemented by independent cross-checking from a certified third-party organization.
We exclusively utilize a premium GMP-grade culture medium that is entirely free of both serum and animal-derived components to maximize patient safety. This advanced formulation perfectly maintains the natural morphology, undifferentiated state, and potent immunomodulatory capacity of Mesenchymal Stem Cells (MSCs), ensuring optimal compatibility with cells derived from multiple tissue sources.
Utilizing an advanced DMSO-free preservation solution combined with a high-precision programmable freezer, the cells are gently and slowly cooled to -80℃ before being safely transferred to liquid nitrogen at -196℃ for long-term cryopreservation. Following a precise thawing process at 37℃, all samples are rigorously monitored and managed within our secure, multi-stage Master and Working Cell Bank system.
Strictly adhering to global clinical GMP standards, we perform rigorous autoclaving sterilization at either 121°C for 20 minutes or 134°C for 5 minutes. A flawless sterile environment is permanently guaranteed through our proactive protocol of weekly environmental disinfection, thorough bacterial testing, and meticulous record management.
| Clinic hours | 10:00～19:00 |
|---|---|
| Close | Sunday, 1st & 3rd Wednesday |
| Address | 〒107-0062 5-9-15 Minamiaoyama, Minato-ku, Tokyo, Aoyama OHMOTO Building 3F |
| Phone | 03-3400-2277 |