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【English】Human Stem Cell Culture Supernatant (Exosome-Enriched) Therapy

What Is Stem Cell Conditioned Media (Exosome-Containing Solution)?

Diagram showing how cytokines and exosomes function

Human stem cell conditioned media is a purified form of the culture medium used when culturing and expanding human stem cells – the supernatant obtained during stem cell culture. While this conditioned media does not contain the cells themselves, it is rich in active components such as cytokines – including various growth factors, immune-regulating factors, anti-inflammatory factors, and nerve regeneration factors – and exosomes, and is expected to contribute to the repair of damaged and aged cells, suppression of inflammation, and regeneration of blood vessels and nerves, serving as a complement to or alternative for stem cell therapy.
Our clinic carefully selects highly reliable manufacturers and thoroughly verifies component specifications, content, and safety testing before providing safe and effective stem cell conditioned media therapy.

For those considering conditioned media / exosome therapy

*Cytokines are signaling molecules that regulate cell proliferation and immune function, transmitting information to other cells. Exosomes are vesicles secreted outside the cell that contain growth factors and other substances and are involved in intercellular communication and tissue regeneration. Both are expected to produce effects similar to stem cell therapy in the field of regenerative medicine.

The Various Growth Factors Contained in Stem Cell Conditioned Media (Exosome-Containing Solution)

  • HGF (Hepatocyte Growth Factor)
  • Anti-fibrotic, anti-inflammatory, repair-promoting: HGF promotes cell migration and survival, playing a central role in cell accumulation at damaged sites and tissue repair. It also has anti-fibrotic effects and is broadly involved in the regenerative process following organ damage to the liver, lungs, kidneys, and other organs.
  • NGF (Nerve Growth Factor)
  • Nerve regeneration and neuroprotection: Suppresses cell death at the time of injury and contributes to nerve cell growth, maintenance, and regeneration through axonal elongation and neurite formation after injury. Some reports suggest it may help improve cognitive function.
  • VEGF (Vascular Endothelial Growth Factor)
  • Angiogenesis and improved microcirculation: Promotes the proliferation of vascular endothelial cells and angiogenesis, improving blood supply to tissue. Normalizes oxygen and nutrient supply and hypoxia at wound sites, supporting the tissue repair process.
  • EGF (Epidermal Growth Factor)
  • Epithelial repair, cell proliferation: Promotes the proliferation and migration of epithelial progenitor cells, supporting functional recovery of a wide range of epithelial tissues including skin, digestive, and respiratory systems.
  • KGF/FGF-7 (Keratinocyte Growth Factor)
  • Induces epithelial cell differentiation: Acts selectively on keratinocytes, promoting proliferation and differentiation, contributing to skin/mucosal barrier function, moisture retention, and epithelial stability.
  • TGF-α (Transforming Growth Factor)
  • Tissue regeneration (fibrosis management): Acts on dermal fibroblasts, promoting the production of structural components such as collagen and elastin, contributing to tissue structure stabilization and reconstruction during the repair process.
  • Exosomes
  • Extracellular vesicles that contain growth factors and other substances, involved in intercellular communication and tissue regeneration.

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Our Commitment

  1. Carefully Selected Human Stem Cell Conditioned Media (Exosome-Containing Solution)
    All components are derived from human sources. For adipose- and dental pulp-derived products, donors are healthy Japanese individuals. *For umbilical cord-derived products, donors are Korean.
  2. Ensuring Safety
    Under strict quality control, the conditioned media we select are manufactured entirely within Japanese university research laboratories or Class 100 CPC (Cell Processing Center) facilities, undergo thorough purification of impurities, and have their safety confirmed through virus testing, sterility testing, and other methods.
  3. Using Conditioned Media High in the Growth Factor HGF

    Graph showing HGF content of adipose-derived conditioned media

    The [adipose-derived] conditioned media uses a special concentration technology to achieve the highest HGF content among human stem cell conditioned media (exosome-containing solutions). HGF is one of the most important growth factors among cytokines, with combined effects including tissue repair/regeneration (particularly in the liver, kidneys, and lungs), anti-inflammatory action, anti-fibrotic action (suppressing TGF-β), and neuroprotective action, which is why it is increasingly used alone or in combination with other factors. The abundant HGF and related factors are expected to contribute comprehensively to organ repair, blood vessel and tissue regeneration, and improved skin/hair quality.
    Impurities in the conditioned media are also strictly removed (purified), including infectious viruses, bacteria, and unnecessary DNA fragments. All stem cell donors are healthy Japanese women, and the product is manufactured under centralized management within a domestic university research laboratory.
  4. Combining IV Infusion and Nasal Spray for Cognitive Improvement

    Graph showing improvement in dementia scale scores with nasal administration

    For cognitive improvement, combining [adipose-derived] IV infusion with [nasal spray] has been shown to be effective. A clinical study administering conditioned media preparations via nasal spray reported improved dementia scale scores in 18 patients with mild to moderate symptoms.
    *”Safety and Clinical Efficacy of Intranasal Administration of Mesenchymal Stem Cell Secretome for Alzheimer’s Disease and Future Prospects” Morita Y, Izawa H, Ohga H, Sugie H, Yamamoto T, Hirano A, Nakamura M, Isozaki S, Seino K, Yonei Y. Safety and clinical efficacy on intranasal administration of mesenchymal stem cell-derived secretome in patients with Alzheimer’s disease and its future prospect. Glycative Stress Research. 2024;11(3):103–110. (Figure cited from https://www.toukastress.jp/webj/article/405)
  5. A Lineup Tailored to Your Goals
    In addition to [adipose-derived], which offers comprehensive effects, [dental pulp-derived] and [umbilical cord-derived] options are also available.
  6. Also Used in Aesthetic Treatments
    Conditioned media options are available for delivering active ingredients into the scalp (hair regrowth treatment HART-F) or skin (Mesona Plus skin treatment) via electroporation.

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Who This Is For

  • Those who tire easily or feel their age catching up with them (a general sense of decline, physically and mentally)
  • Those who feel unwell or lack vitality
  • Those who want to feel more youthful
  • Those whose hair lacks volume, with a noticeable scalp
  • Those experiencing significant hair loss
  • Those with dullness, wrinkles, spots, or melasma
  • Those whose skin has lost firmness and radiance

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A Somewhat Technical Explanation > What Are Growth Factors / Cytokines?

Details

Diagram showing how growth factors and cytokines are transmitted between cells

Growth factors and cytokines are signaling molecules that regulate cellular activity, triggering a wide range of physiological responses in the body by controlling gene transcription within the cell nucleus. Growth factors in particular are involved in a broad range of physiological processes in the adult body, including cell proliferation and differentiation, apoptosis, immune regulation, hematopoiesis, angiogenesis, metabolism, wound healing, and maintenance of tissue homeostasis. These signals are released when the cells secreting the growth factor or cytokine receive some form of stimulus, and they exert their function once transmitted to target cells.

A Somewhat Technical Explanation > What Are Exosomes?

Details

Diagram showing the mechanism by which exosomes support tissue repair

Exosomes are extracellular vesicles (EVs) secreted by cells that mainly contain growth factors and intercellular signaling substances that promote tissue regeneration. Exosomes play an important role in cell-to-cell communication and are expected to have applications across a wide range of diseases. In the field of regenerative medicine, exosomes derived from mesenchymal stem cells (MSCs) have attracted particular attention. They exhibit a variety of therapeutic effects, including anti-inflammatory action, anti-fibrotic action, promotion of angiogenesis, and promotion of tissue repair, and are expected to serve as a form of “cell-free therapy.” For example, in myocardial infarction models, MSC-derived exosomes have been shown to suppress cardiomyocyte apoptosis (cell death), promote angiogenesis, and reduce inflammation. Protective and regenerative effects on tissue have also been demonstrated in various disease models including renal failure, pulmonary fibrosis, and arthritis. These effects are thought to be exerted through miRNAs and proteins contained within exosomes, which regulate gene expression in target cells; going forward, exosomes are expected to find applications as a complement to, or alternative for, cell therapy.

Late-Phase Clinical Trials of Exosome Administration in Humans [Adipose-Derived]

Details

Below is a selection of clinical trials in which exosomes and related substances have been administered to humans. Exosome therapy for the improvement of various inflammatory conditions and diseases is expected to continue developing going forward. At the same time, the level of scientific evidence cannot yet be described as fully established. While many medical institutions already offer exosome-based treatments, current clinical application should be approached carefully and with the utmost caution. (Phase 2/3)
• Efficacy and Safety of EXOSOME-MSC Therapy to Reduce Hyper-inflammation In Moderate COVID-19 Patients
• Effect of Microvesicles and Exosomes Therapy on β-cell Mass in Type I Diabetes Mellitus (T1DM)
• The Effect of Stem Cells and Stem Cell Exosomes on Visual Functions in Patients With Retinitis Pigmentosa
• Use of Autologous Plasma Rich in Platelets and Extracellular Vesicles in the Surgical Treatment of Chronic Middle Ear Infections
(Phase 3)
• Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)

Reagent Specifications and Safety Test Results [Adipose-Derived]

Overview

Product name: Human Adipose Stem Cell Conditioned Media Extract (Freeze-dried)
Classification: Research reagent
Origin: This product is a freeze-dried solution obtained by purifying and concentrating the culture medium of cultured human adipose-derived stem cells
Country of origin: Japan

Preparation Site (Manufacturing Site) CPC attached to a university hospital (GMP-compliant)
Product Contents Undiluted solution
Country of Manufacture Japan
Donor Japanese
Donor Screening (Infectious Disease) 7 items
Number of Donor Blood Tests 1
Virus Testing (Finished Product) Tested
Mycoplasma Testing Negative
Sterility Testing Negative
Endotoxin Testing Less than 0.015 EU/ml
Product Control Per lot
Exosome Measurement
*Exosome content in the conditioned media is not disclosed, as measurement standards have not yet been established and reliable measurement is difficult.

Analysis Items

Appearance: White powder; transparent to pale yellow, odorless liquid (when dissolved)
TBU: 120 TBU or higher <ELISA method>
NH3: Less than 10 µg/dl (when dissolved in 2ml) <indicator method>
pH: 7.4 ± 0.3 (when dissolved in 2ml) <glass electrode method>
Heavy metals: Not detected <sodium sulfide colorimetric method>
Arsenic: Not detected <atomic absorption spectrophotometry>
Storage conditions: Store refrigerated (2-6°C) in a sealed container, avoiding direct sunlight
Shelf life: 3 years after manufacture (once opened, use promptly to avoid microbial contamination)
Allergens: None
GMO: Not applicable
Animal-derived components: None

Safety Test Results

1. Bacterial Testing
– Sterility test <detection by SCDLP agar plate and GPLP agar plate methods> Negative: Passed
– Mycoplasma test <detection by NAT method> Negative: Passed
– Endotoxin test <measurement by gelation method> Less than 0.015 EU/ml: Passed
2. Skin Primary Irritation Test <LabCyte EPI-MODEL24 SIT test method using a 3D cultured intradermal model>
Overview: Cell viability of the test substance was shown. Because the cell viability of the test substance (measured value: 101.1 ± 1.1%) was higher than 50%, the skin primary irritation of the test substance, “10% solution of human adipose stem cell conditioned media purified extract (freeze-dried),” was classified as “not applicable” (i.e., a substance that can be considered non-irritating to the skin).
3. Toxicity Testing (Mouse Oral Administration)
No toxicity was observed in a single-dose oral toxicity test in mice (up to 2000 mg/kg).
Overview: 5 male and 5 female mice were each given a single oral dose of 2000 mg/kg of the human adipose stem cell conditioned media purified extract (freeze-dried) sample (dissolved in distilled water), observed for 14 days from Day 1 (day of administration), and necropsied on Day 15.

Virus Testing

1) Adipose Stem Cell Donor Testing
– Hepatitis B Virus (HBV) <HBs antigen, HBc antibody detected by CLIA method> Negative: Passed
– Hepatitis C Virus (HCV) <HCV antibody II detected by CLIA method> Negative: Passed
– Human Immunodeficiency Virus (HIV) <HIV antigen/antibody detected by CLIA method> Negative: Passed
– Human T-cell Leukemia Virus (HTLV) <HTLV-1 antibody detected by CLEIA method> Negative: Passed
– Human Parvovirus B19 (PVB-19) <PVB19-DNA identified by PCR method> Negative: Passed

2) Product Testing
– Hepatitis B Virus (HBV) antigen <HBs antigen detected by CLIA method> Negative: Passed (less than 0.005 IU/ml)
– Hepatitis B Virus (HBV) antibody <HBs antibody detected by CLIA method> Negative: Passed (less than 0.1 COI)
– Hepatitis C Virus (HCV) antibody <HCV antibody II detected by CLIA method> Negative: Passed (less than 0.1 COI)
– Human Immunodeficiency Virus (HIV) antigen <HIV antigen detected by CLIA method> Negative: Passed
– Human Immunodeficiency Virus (HIV) antibody <HIV antibody detected by CLIA method> Negative: Passed
– Human T-cell Leukemia Virus (HTLV) antibody <HTLV-I antibody detected by CLIA method> Negative: Passed
– Human Parvovirus B19 (PVB-19) <PVB19-DNA identified by PCR method> Negative: Passed

Source: Manufacturer’s report

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Treatment Flow

  1. Counseling
  2. The physician will check your symptoms and concerns during counseling and determine the method and dosage of administration.
  3. Administration (IV infusion / injection)
  4. An injection takes about 5 minutes; an IV infusion takes about 30-60 minutes.
*Optional administration via HART-F (scalp introduction) or Mesona Plus (skin introduction) is described on each respective treatment page.

Treatment Frequency and Duration

IV infusions are generally administered once every 1 to 4 weeks. Some patients notice an effect after a single treatment, but many report gradually experiencing more effect with repeated treatments. Local injections are administered into localized areas such as joints to help manage chronic pain.
*Optional administration via HART-F (scalp introduction) or Mesona Plus (skin introduction) has its own treatment frequency and duration described on each respective treatment page.

Side Effects / Risks

Bruising or mild pain may occur at the injection/infusion site.
*Optional administration via HART-F (scalp introduction) or Mesona Plus (skin introduction) has its own side effects/risks described on each respective treatment page.

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Price List

Stem Cell Conditioned Media (Exosome-Containing Solution) Treatment Fees

Umbilical Cord-Derived: “Young Cells” Rich in Exosomes 1V ¥70,000
(Tax incl. ¥77,000)
3V ¥199,500
(Tax incl. ¥219,450)
5V ¥315,000
(Tax incl. ¥346,500)
Adipose-Derived: High-Density Concentrated HGF, All-Purpose Type 1V ¥50,000
(Tax incl. ¥55,000)
3V ¥142,500
(Tax incl. ¥156,750)
5V ¥225,000
(Tax incl. ¥247,500)
Dental Pulp-Derived: Nerve Cell Regeneration 1V ¥30,000
(Tax incl. ¥33,000)
3V ¥85,500
(Tax incl. ¥94,050)
5V ¥135,000
(Tax incl. ¥148,500)

Nasal Spray (Adipose-Derived)

Nasal Spray (Adipose-Derived) 1 bottle (approx. 1 month supply) ¥45,000
(Tax incl. ¥49,500)
4 bottles (40 pushes, approx. 1 week supply) ¥171,000
(Tax incl. ¥188,100)

Combination Plan Example (Equal Quantities of Dental Pulp, Adipose, and Umbilical Cord)

Combination Dental Pulp 1V + Adipose 1V + Umbilical Cord 1V ¥150,000
(Tax incl. ¥165,000)
Dental Pulp 3V + Adipose 3V + Umbilical Cord 3V ¥427,500
(Tax incl. ¥470,250)
Dental Pulp 5V + Adipose 5V + Umbilical Cord 5V ¥675,000
(Tax incl. ¥742,500)

◆ Dosage: For each line, you may choose 1V to 5V per infusion session. Multiple treatment sessions may be proposed depending on your treatment goals.
◆ Combining multiple lines: Combination plans of Dental Pulp, Adipose, and Umbilical Cord are also available. Please consult us for individualized plans.
◆ Method of administration: IV infusion, local injection, or electroporation-based introduction (Mesona Plus / HART-F).
◆ Fees include: The cost of the conditioned media preparation and the infusion procedure fee.

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