FAQ FAQ

At Helene clinic, we place the highest priority on cell "viability" and "purity". By utilizing our proprietary culture medium, "Helene Medium," we are able to successfully proliferate cells while keeping their natural activity at its peak. Furthermore, we employ advanced technologies like MACS (Magnetic Cell Separation) to precisely extract and manage only the specific stem cells that deliver effective therapeutic benefits. Every step of this meticulous process is rigorously carried out within our own state-of-the-art culture facility, which is fully ISO 9001 certified.

Our hospital owns its own cleanroom (CPC) that has obtained the international standard ISO9001. In addition, we use our proprietary culture medium "Helene Growth Medium" which maximizes cell viability, and our specialized culture technicians perform rigorous quality checks (bacterial testing, viral testing, cell counting, etc.) on all cases. This thorough management system supports the overwhelming cell quality of 2.25 billion cells.

Depending on the patient's condition and treatment objectives, our hospital can provide high doses of up to 2.25 billion stem cells in a single administration using our uniquely developed cell culture technology. Generally, the number and quality of cells administered are considered important factors influencing the effectiveness of treatment, and our hospital has earned a strong reputation for providing these "high-concentration, high-quality" cells.

Every single stem cell for our patients is cultured with complete consistency in our specialized, state-of-the-art in-house lab (CPC). Furthermore, all of our cell culture facilities have been formally accepted under the "Notification of Manufacturing Specific Cell-Processed Products" by the Ministry of Health, Labour and Welfare, and have achieved ISO 9001 certification, reflecting our commitment to global quality standards (Helene AO Building clinic is currently in the ISO 9001 application process).

In 2018, we proudly presented the groundbreaking results of our proprietary serum-free culture medium, HELENE Medium, at the prestigious Cambridge International Stem Cell Symposium. Our presentation highlighted two key breakthroughs: First, that HELENE Medium enables the cultivation of a significantly higher volume of cells within the exact same timeframe compared to other standard commercially available options. Second, that mesenchymal stem cells (MSCs) cultured in HELENE Medium retain the smallest and most compact physical size. Crucially, there is strong academic consensus that smaller, more compact stem cells are remarkably less prone to premature differentiation into fibroblasts. By combining these two powerful advantages, we have successfully verified that the adipose tissue collected from just behind the ear contains a highly viable and rich population of MSCs. While the volume of fat tissue harvested from this area is understandably minimal compared to the thigh or abdomen, our unique in-house laboratory technology paired with HELENE Medium makes it entirely possible to culture up to 2.25 billion high-quality MSCs in just one single month.

[Safe and pure stem cell culture technology and culture medium]
https://stemcells.jp/technique/

The seamless combination of three essential pillars—our proprietary serum-free culture medium (HELENE Medium), our advanced vertical culture vessels, and our highly experienced team of cell cultivation specialists—is what uniquely empowers Helene to maintain pristine stem cell quality while successfully culturing and administering up to 2.25 billion stem cells. If even a single one of these elements is missing, achieving this elite standard of both quality and volume becomes simply impossible.

Upon the completion of the stem cell cultivation, our clinic implements a rigorous three-stage verification protocol to ensure the quality. First, we utilize the autoMACS magnetic bead separation system to definitively verify the absolute purity and identity of the stem cells. Second, the Countess 3FL automated cell counter is employed to precisely measure the exact, actual number of viable stem cells. Third, we leverage a cutting-edge AI image recognition system developed entirely in-house to accurately evaluate the overall cell viability rate. Only the cells that have successfully cleared every single one of these three stringent phases are handed over to our medical department for use in patient administration.

[About Helene in-house lab]
https://stemcells.jp/lab/