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Stem-cell therapy
Healing treatment utilizing the inherent healing power of humans
What are stem cells?
Life starts from a single fertilized egg, which then proliferates to 37 trillion cells, dividing into 270 different types of cells such as nerves, blood, and muscles. Each of these cells has its own function and maintains the life. Cells that can differentiate into various types of cells during this process are called stem cells.
Functions of stem cells
When our bodies are injured, we can naturally repair the damage, and stem cells play a crucial role in this process. Stem cells have the ability to repair and regenerate damaged tissues, restoring their function. Stem cells also secrete substances such as cytokines and exosomes, which are widely used in tissue repair and anti-aging treatments.
In our daily lives, we may become ill or injured, but stem cells are playing an important roles in healing and restoring damaged tissues.
Case reports of Stem-cell therapy
Stem-cell therapy has the effects of repairing tissues such as skin, muscles, nerves, and internal organs. It has been reported to have numerous effects, including pain relief, treatment of diabetes, neurological disorders (such as ALS and Parkinson's), autoimmune diseases, and anti-aging effects.
Homing effect of stem cells
When tissues in the body are injured, they can send out some signals, like an SOS, to attract stem cells to the area. This mechanism of stem cells gathering at the injured site is called the homing effect. In this therapy, stem cells are taken from the patient's own tissues, cultivated in vitro, and then reintroduced into their body. The stem cells that have returned to the body respond to the SOS signals and gather at the damaged site, acting as a powerful support team to help repairing the injured tissue. This is how Stem-cell therapy that utilizes the homing effect works.
About Stem-cell therapy
This is a treatment that cultivates stem cells picked up from a patient's fat and administers them intravenously. Long-term effects can be expected compared to the culture supernatant. Since the patient's own cells are used, there is a lower risk of unknown infections, making it a safe treatment. (Second-class Regenerative Medical Service Plan Number: PB5220009, Indication: Chronic Pain) (Second-class Regenerative Medical Service Plan Number: PB5220056, Indication: Arteriosclerosis accompanying lifestyle-related diseases such as hypertension, diabetes, Mellites, etc.)
Flow of Stem-cell therapy
STEP-1 CounselingThe doctor and staff will explain the treatment.
STEP-2 Fat CollectionAdipose tissue mainly from the abdomen and other areas will be collected. A laser suction device called LIPOLIFE is used to obtain the maximum number of stem cells with a small amount of fat collection. The stem cells within the collected tissue can be used for culture without damage. By using LIPOLIFE and reducing the amount of collection, patients’ pain, bleeding, and downtime can be minimized.
STEP-3 Stem Cell Cultivation After tissue collection, the cells are immediately cultured at the clinic’s Cell Processing Center (CPC). It will take about 3 weeks to prepare 100 million stem cells for one shot because stem cells can be cultured in high quality.
STEP-4 Drip InfusionThe stem cells are slowly reintroduced by infusion for about an hour. In our clinic, we transport the stem cells in a live state directly from the clinic’s CPC, which allows us to administer healthy cells with higher survival rates than those that have been frozen.
STEP-5 ExaminationAfter the stem cell therapy, we will examine the symptoms at 1, 3, and 6 months (online, etc.). For those who will receive multiple treatments, we will get the next appointment.
Cautions
• The treatment fee will be needed at the time of fat collection, so please pay the treatment fee before the fat collection date.
• We keep the stem cells for infusion in a live state without freezing. If you cancel infusion date suddenly, we have to discard the stem cells. Please note that we cannot refund the treatment fee (cultivation fee) in that case.
LIPOLIFE
LIPOLIFE is a laser-based fat extraction device used for stem cell collection.The device is manufactured in Israel, equipped with the latest technology approved by the US FDA. We can collect stem cells with high survival rates in a gentle way, and reduce the risk of damage to surrounding tissues such as skin and muscle compared to conventional liposuction. The postoperative pain is minimal, and the downtime is also significantly reduced.
Dr. Komura, the director of the Rinku Medical Clinic, and Dr. Muranishi, the director of the Kyoto Oike Medical Clinic, have received certification after completing training at the international training facility for this device.
Cell Processing Center (CPC)
We have equipped our center with state-of-the-art culture devices that meet strict standards, and stem cells are managed by experienced technicians and doctors. Our center is directly connected to the clinic, allowing us to start culturing stem cells in a fresh state with high survival rates and have stem cells with excellent quality *1. Unlike CPCs in other facilities that culture and administer cells, there is less stress during transportation and less depletion, resulting in greater effectiveness. (Facility registration number FC5190068)
A graph shows measuring the energy activity level of stem cells.
Sample 1: Stem cells that were frozen and stored immediately after thawing.
Sample 2: Stem cells that were frozen and stored, then cultured again.
Sample 2 shows a more active energy level in stem cells compared to Sample 1.
Fat Extraction～Image leading up to administration
Fat Extraction
Extraction is performed in an operation room with clean air. The fat collected with LIPOLIFE appears yellow with little blood contamination.
Cultivation
① The adipose tissue is immediately transported to the cultivation facility on the same floor. Materials and specimens used for cultivation are carefully sterilized and transported to the cultivation room through a specific path (pass box).
② The procedure is performed in the cleanest and most sterile area called the safety cabinet. The specific cultivator performs the cultivation carefully to avoid all kinds of contamination. To provide patients with high-quality and highly safe stem cells, cultivators receive specialized training.
③During cultivation, a specimen identification system is used to prevent the patient's cells from being mixed up with those of other patients. Additionally, double-checks are performed by multiple staff.
④Cells are grown in a specific device called an incubator, which is carefully controlled to maintain consistent temperature and humidity.
⑤When passaging (transferring the increased stem cells to a new culture), the cells' shape, size, and other characteristics are checked.
⑥Stem cells that are not immediately used for treatment are stored in liquid nitrogen. The treatment of this tank is always maintained lower than -170℃, allowing cells to be stably preserved. In re-infusing stem cells, frozen cells are re-cultured and re-activated to restore them to a healthy state.
⑦Quality and safety are always checked when cultivating a patient's stem cells. The test results shown below demonstrate the verification of the cultured cells as stem cells by confirming that all surface markers, CD73, CD90, and CD105, are positive.
Administration
The stem cells are administered slowly over approximately 1 hour.
Risks/side effects
There is a risk of bleeding, hematoma, poor wound healing, infection, etc. associated with the incision in the patient's abdomen or thigh during fat inspiration. When injecting stem cells, there is no risk of rejection response, but there may be fever, headache, vomiting, and swelling at the injection site after administration. In addition, there was one report of pulmonary embolism in another hospital in 2010, but the relationship with this treatment is unknown, and no cases have been reported since then.
Approval status of domestic pharmaceuticals and method of acquisition
Because the treatment uses one's own adipose tissue, there are no other domestically approved pharmaceuticals available. The treatment will be performed based on the Second Category Regenerative Medical Care Supply Plan number: PB5220009.
Clarification of information related to safety in other countries
・E Russell Vickers et al., A preliminary report on stem cell therapy for neuropathic pain in humans. Journal of Pain Research, 2014:7 255–263
・Ralph Bright et al., Migraine and tension-type headache treated with stromal vascular fraction: a case series. Journal of Medical Case Reports 2014, 8:237
・Sudabeh Alatab et al., Systemic Infusion of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in Peritoneal Dialysis Patients: Feasibility and Safety. Cell J, Vol 20, No 4, Jan-Mar (Winter) 2019
The idea of storing stem cells
Stem cell therapy is expected to have many benefits. However, it is impossible to administer stem cells from another person, and only the patient's own stem cells can be used for treatment. So, what happens if someone wants to undergo this treatment after suffering a serious injury? The process of undergoing anesthesia and liposuction while in such situation might have additional risks. Additionally, the number of stem cells they can obtain decreases year by year.
Stem cell banking is a proposal to collect and store stem cells while they are still relatively young, for your future. This approach can be done in our clinic because we have a cell culture center where cells can be collected, cultivated, and stored.
Treatment Procedure:
The stem cells are extracted from the collected fat and cultivated to a certain amount. The obtained stem cells are divided into multiple storage containers and kept frozen until needed.
Stem-cell conditioned medium
What is Stem Cell Condition Medium?
SThere are cells in the body's tissues (such as adipose, bone marrow, and dental pulp) that have various abilities. Among them, there are cells with the ability to differentiate into neurons, blood vessels, and so on. They are called "stem cells." Stem cells play a role in repairing and restoring tissues when they are damaged. For example, when you get a scrape, signals are sent to stem cells, which gather at the site of the injury and release various secretions (physiologically active proteins such as cytokines that activate, grow, and proliferate) to repair the wound. Stem cell cultured supernatant refers to the protein components secreted during the culture of mesenchymal stem cells from tissues, and it has been found that it has various effects equivalent to those of administering stem cells. The latest research shows that over 500 physiologically active substances, such as growth factors and cytokines secreted from stem cells, are included, and they can promote tissue regeneration by activating cells in the body.
This is a treatment by using the supernatant produced by cultured stem cells from healthy Japanese women. While it is derived from other individuals, stem cell culture supernatant from various tissues such as fat, dental pulp, and umbilical cord are available. We recommend the appropriate source tissue and administration method (intravenous drip, nasal drops, subcutaneous injection) based on the patient's symptoms. It can be administered on the day of visit, and there are no restrictions on bathing or activities afterward. Stem cell-cultured supernatants derived from fat and dental pulp are produced at the CPC in Rinku Medical Clinic.
Types of growth factors contained in stem cell condition medium and expected effects
VEGF (vascular endothelial growth factor)
• Prevents wrinkles by producing new cells.
BFGF (basic fibroblast growth factor)
• Promotes the growth of vascular endothelial cells and angiogenesis.
• Promotes the growth of fibroblasts that produce collagen.
• Has a tissue repair effect.
EGF (epidermal growth factor)
• Expected to improve wrinkles by forming new skin cells.
• Produces new skin cells and promotes wound healing.
PDGF (platelet-derived growth factor)
• Promotes the regeneration of damaged skin cells.
• Promotes the growth of fibroblasts that produce collagen.
IGF-1 (insulin-like growth factor)
• Expected to improve wrinkles by forming new skin cells.
• Produces collagen, hyaluronic acid, and elastin.
Quality and safety unique to medical institutions
Stem cell condition medium is widely used in cosmetics and other products, mainly imported from overseas. Even if standard values are established, the activity may decrease depending on transportation and management methods. At our clinic, we only use products that guarantee growth factor activity values through research conducted by Japanese institutions. We ensure safety by using products that have undergone 42 donor compatibility tests and virus tests, and are produced under GMP/GLP standards.
Types of symptoms that can be treated:
Diabetes, chronic liver and kidney disease, lipid disorders, heart disease, chronic pain syndrome, allergies/eczema, sports performance enhancement, multiple sclerosis, fibromyalgia, rheumatism, hypertension, tinnitus, macular degeneration, chronic fatigue syndrome, migraine, dizziness, depression, skin revitalization.
Risk and Side Effects
There is a possibility of allergic reactions, although reports of serious side effects are rare.
Declaration of being an unapproved drug, disclosure of acquisition route, etc.
The stem cell condition medium drip used in this treatment is not approved under the Pharmaceutical and Medical Device Act. It is lawfully compounded as an in-house dispensing (partially outsourced). In Japan, unapproved drugs can be used under the responsibility of the physician.
Statement of whether there are approved drugs in Japan
There are no other domestically approved drugs with the same performance that can be used for this treatment.