At the prestigious Cambridge International Stem Cell Symposium in 2018, we proudly unveiled the groundbreaking milestones of our proprietary, serum-free culture medium, HELENE Medium. Superior Ex Vivo Expansion Kinetics: Compared to available alternatives, HELENE Medium demonstrated a significantly higher cell yield within the identical cultivation window, showcasing robust proliferative efficiency. Optimized Small Cell Morphometry & Stemness Retention: Mesenchymal stem cells (MSCs) expanded in HELENE Medium consistently exhibited the most compact cell size. Extensive scientific literature corroborates that smaller MSC dimensions serve as a critical morphological indicator of maintained pluripotency/multipotency, effectively preventing spontaneous fibroblastic differentiation and premature cellular senescence.
By integrating these two rigorous validation points, we definitively confirmed the robust presence of high-quality Mesenchymal Stem Cells (MSCs) within the adipose tissue safely collected from behind the ear. Although the initial volume of fat extracted from this area is significantly smaller than that typically taken from the thigh or abdomen, our proprietary laboratory technology combined with the exceptional performance of HELENE Medium empowers us to successfully culture up to 2.25 billion highly active MSCs in just one month.
To unequivocally guarantee the premium quality of the stem cells we provide to
our valued patients, we outsourced specialized validation testing using identical
stem cell samples manufactured through the exact same rigorous process
outlined in this quality certificate. This comprehensive validation strictly
complies with international GMP (Good Manufacturing Practice) and regenerative medicine GLP (Good Laboratory Practice) standards, incorporating three
advanced, uniquely designed proprietary experiments. While we always perform equivalent high-standard testing within our own advanced laboratory prior to
every patient delivery, we proudly present here the independent results verified
by an unbiased third-party testing company to transparently demonstrate the
supreme quality of our cell therapies.
For this validation, we submitted high-purity cellular samples prepared by
culturing the adipose tissue of three individual sample providers directly inside
our advanced laboratory. These premium samples were carefully extracted from
the tissue behind the ear, which was then systematically isolated and dissociated using our specialized techniques and dedicated premium enzymes. After a precise one-month expansion period to ensure the single cells reached the required therapeutic density, they were highly purified via MACS (Magnetic-Activated Cell
Sorting), verified using an automated cell counter, and subsequently provided to Takara Bio Inc., a renowned and trusted third-party testing organization, for
definitive analysis.
| Test Objectives | Test Name | Cell Samples | Result |
|---|---|---|---|
| Infection / Contamination | Sterility Test (Compliant with Japanese Pharmacopoeia Direct Method / Option: Method Suitability Test) | QC_AL Lot:#13349 | Negative |
| Sterility Test(Conducted via Japanese Pharmacopoeia Direct Method) | QC_AL Lot:#13349 | Negative | |
| Mycoplasma Negative Test (Based on Japanese Pharmacopoeia Reference Information: PCR Method with 7 Species Inhibition Validation) | QC_AL Lot:#13349 | Negative | |
| Endotoxin Test (Validated via Japanese Pharmacopoeia Kinetic Turbidimetric Method / Option: Interfering Factor Test) | QC_AL Lot:#13349 | Negative | |
| Endotoxin Test (Japanese Pharmacopoeia Kinetic - Turbidimetric Method) | QC_AL Lot:#13349 | Below Detection Limit (Not Detected) | |
| Tumor Formation | Colony Formation Assay | QC_AL Lot:#13349 | Negative |
| Stem Cell Confirmation | FCM Test (CD45-CD105+) |
QC_AL Lot:#13349 | CD45- 92.1％ CD105+ 100% |
As illustrated in the diagram above, the round, bean-like structures represent the clusters of adipose tissue. The precious
stem cells actually hide within a specialized, fibrous network known as the "stem cell niche." This means that stem cells do not
exist inside the individual lipid droplets themselves, but are instead intricately woven into the surrounding fibrous matrix.
Let us now examine a comprehensive summary contrasting the unique characteristics of post-auricular (behind-the-ear) fat versus traditional abdominal fat.
| Post-auricular (behind-the-ear) | Abdominal fat | |
| Visual Evidence: Exterior |
 |
 |
| Figure |  |
 |
| Pain | Few | Strong (pain like a bruise) |
| Internal Bleeding |
Very rare | Many |
| Compression | Compression with the bandage | Compression with the gauze |
Adipose-derived cells are not located within the yellow lipid droplets themselves, but rather reside in the specialized
microenvironment surrounding them, known as the stroma—or the "stem cell niche." While stem cells exist within both
abdominal and post-auricular (behind-the-ear) fat, tissue that features fewer lipid droplets and a richer stromal matrix yields a
significantly higher density of these potent stem cells. To ensure a premium and comfortable experience, Helene primarily
harvests fat from behind the ear, an advanced method that drastically minimizes physical burden and post-procedural pain for
our patients. However, we fully accommodate individual preferences; should you prefer traditional abdominal harvesting,
extraction via gentle abdominal liposuction remains readily available.
To guarantee the absolute quality of therapy, stem cells cultured at the HELENE Cell Center undergo a rigorous, multi-stage
measurement process at least twice to verify both cell count and viability prior to patient administration. Every validation result is officially verified and printed directly within our advanced laboratory to maintain complete, unalterable transparency. We are profoundly dedicated to delivering these life-enhancing therapies to all our clients through an impeccably scientific, compliant, and deeply responsible approach.
Once the cell samples are obtained, they are stained using a 0.4% Trypan Blue
solution, a premier vital stain widely trusted to differentiate between viable and
non-viable cells. This technique relies on a classic dye exclusion assay: the stain
effortlessly penetrates the compromised membranes of dead cells while being
completely blocked by the intact membranes of living cells, allowing for an
exceptionally precise viability calculation. While traditional protocols relied on
labor-intensive manual counting under a microscope, our facility utilizes an
automated cell counting system that instantaneously recognizes the fluoroscopic
response to deliver a flawless, automated analysis. Manual counting not only requires meticulous hand-focusing but also demands constant, subjective adjustments of the bright-field illumination between different samples. To eliminate these human variables, the state-of-the-art Countess II FL automated cell counter automatically optimizes both illumination
and focus, capturing the absolute highest image quality for perfectly reproducible results every single time.
Following the initial volumetric measurement with the Countess II FL, our specialized cell center places the sample on a high-precision slide to capture detailed cellular imagery using the advanced ZEISS Axio Vert.A1 microscope. Utilizing
HELENE’s proprietary, custom-developed AI image analytics program, we observe the cytoskeleton at a near-confocal
resolution—intricately calculating the exact cell count and viability by cross-referencing the microscope's precise focal
length, specific cell type (MSC), and the exact cross-sectional surface area of the culture flask. By seamlessly integrating
these two rigorous steps, we achieve a calculation accuracy approaching a flawless 100%, establishing a uniquely
tailored, artisanal process that remains completely unrivaled across the industry, while guaranteeing that HELENE’s
premium therapeutic-grade stem cells are perfectly optimized to fulfill each patient's individual medical needs.
Following every single procedure, HELENE clinic provides each patient with an official Stem Cell Quality Certificate, proudly demonstrating our unwavering commitment to therapeutic excellence, absolute quality, and complete operational transparency.
According to a landmark 2021 meta-analysis titled "The safety of MSC therapy over the past 15 years," 62 rigorous studies were selected for comprehensive review, featuring prominent clinical trial data published in the internationally
renowned medical journal The Lancet. Across these global clinical trials, massive doses ranging from over 500 million to as many as 1 billion MSCs were safely administered—a definitive milestone that completely dispels common
misconceptions while firmly validating that HELENE Clinic’s advanced technological capabilities stand shoulder-to-
shoulder with the world's leading research institutions.
| Author | Year | Location | Dose | |
|---|---|---|---|---|
| Hess | 2017 | USA | 1200×106 cells | 1.2 billion stem cells |
| Bartunek | 2013 | Belgium | 600 -1200×106 cells | 6-1.2 billion stem cells |
| Chanbers | 2017 | Australia | 1×109 cells | 1 billion stem cells / lung injury |
| Steinberg | 2017 | USA | 1×109 cells | 1 billion stem cells / stroke |
| Igresias | 2021 | Mexico | 1×109 cells | 1 billion stem cells / lung injury |
| Matsuoka | 2024 | Japan | 1-2×109 cells | 2 billion stem cells / AntiAging |
Accumulated clinical evidence strongly suggests that low-dose MSC therapies may
fundamentally lack efficacy in certain scenarios, as documented cases of successful
low-dose administrations for specific pathologies remain virtually non-existent. In
the near future, driven by the ongoing evolution of scientific data, the global medical community must continuously refine and standardize MSC treatment protocols,
including target patient demographics, tissue sources, expansion methodologies, and precise dosage parameters to enable rigorous, comparative clinical analysis.
Anticipating this global shift, HELENE Clinic has already pioneered highly tailored
reinfusion programs that adjust the precise quantities of stem cells and exosomes
based on each patient’s unique age, physiological profile, and underlying medical
condition—relentlessly advancing our protocols to guarantee the absolute pinnacle
of therapeutic efficacy under the most stringent safety standards.
[Citation] The safety of MSC therapy over the past 15 years: a meta-analysis.
https://doi.org/10.1186/s13287-021-02609-x
| 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 |