Stem cell therapy

Sunfield Clinic is a medical institution that provides regenerative medicine using stem cells.

Medical institutions that provide regenerative medicine using stem cells must create a regenerative medicine provision plan for each regenerative medical technique they implement, and undergo a review of safety, effectiveness, etc.
by the Specially Certified Regenerative Medicine Committee, approved by the Ministry of Health, Labour and Welfare . Sunfield Clinic is a medical institution that has submitted an approved regenerative medicine plan to the Ministry of Health, Labour and Welfare and obtained a Type 2 regenerative medicine provision plan number.
□ Regenerative medicine, etc. provided: “Autologous adipose-derived mesenchymal stem cell therapy for the prevention of the progression of arteriosclerosis”
(Classification of regenerative medicine, etc.: Type 2, Plan number PB3230222)
□ Regenerative medicine, etc. provided: “Autologous adipose-derived mesenchymal stem cell therapy for the relief of chronic pain”
(Classification of regenerative medicine, etc.: Type 2, Plan number PB3230228)

Stem-cell therapy

~The potential of mesenchymal stem cells~

There are approximately 60 trillion cells in our bodies. Our tissues, such as the heart, brain, and skin, are made up of a collection of cells, and they play very important roles in our daily lives. Cells are divided into approximately 270 types depending on their role. The cells that are the source of these cells are “stem cells.” Stem cells can change into various cells and tissues, and exist in specific locations within the body. They are cells that produce cells to replace tissue when it is damaged.

These stem cells have long been known to exist in bone marrow. However, there is a limit to the number of stem cells that can be extracted from bone marrow, and extraction requires surgery that places a burden on the patient, such as general anesthesia. In 2000, Dr. Hedrick of UCLA (University of California, Los Angeles) discovered that abdominal subcutaneous fat contains large amounts of stem cells. A wide range of research has been conducted into the basic characteristics of adipose-derived mesenchymal stem cells. Adipose-derived mesenchymal stem cells are easy to extract, highly safe, and have a wide range of efficacy, making them garnering attention as key cells in regenerative medicine.

Furthermore, the Act on Ensuring the Safety of Regenerative Medicine, etc. (Act No. 85 of 2013) came into effect on November 25, 2014, establishing rules that medical institutions and cell processing product manufacturers must respect in order to ensure the safe progress of clinical research (such as clinical research using human stem cells) and the research, development, and practical application of high-quality regenerative medicine, etc., under the elective medical treatment system. This has created an environment in which regenerative medicine, etc., can be provided quickly and safely.

Sanfield Clinic has received regenerative medicine provision plan numbers from the Ministry of Health, Labor and Welfare, and offers the following treatments: “Autologous adipose-derived mesenchymal stem cell therapy for the prevention of the progression of arteriosclerosis” (Type 2, plan number PB3230222) and “Autologous adipose-derived mesenchymal stem cell therapy for the relief of chronic pain” (Type 2, plan number PB3230288).

Flow of treatment

Prior explanation and consent

When undergoing stem cell therapy, your doctor will thoroughly explain the purpose, safety, risks, and effectiveness of each stem cell therapy.
Stem cell therapy can only be performed with the consent of both the patient and the doctor.
1

Pre-inspection

(Selection criteria and viral blood tests)
You will undergo tests (in-hospital and blood) to determine the selection criteria for stem cell therapy according to your donation plan, and a doctor will determine your suitability. If your suitability is confirmed, your blood will be drawn for a virus test (7 items). The virus test results will be available in about a week, and if all results are negative, you will proceed to fat collection.
2

fat harvesting

(Collection of subcutaneous adipose tissue)
Subcutaneous adipose tissue is mainly collected from the subcutaneous fat of the abdomen.
Local anesthesia is administered, and the amount collected is approximately 20 to 30 grams or more.
3
4

Stem cell culture/processing

Stem cells are extracted from the collected fat tissue and carefully cultured for approximately six weeks. The cells are then subjected to quality testing for two weeks. The stem cells are grown under strict quality control, and it takes approximately eight weeks from the date of fat collection until they are administered.
Stem cell cultivation is carried out under strict quality control at a contracted cell processing manufacturing facility.

Stem cell administration

(Administered by intravenous drip injection)
The cultured stem cells are administered via intravenous drip infusion, which
is administered slowly over a period of about 40 minutes.
5

Follow-up examination

(Prognosis checkup)
Patients will be asked to visit our clinic to verify the effectiveness of each stem cell therapy.
We will confirm the efficacy and safety of stem cell therapy for each patient.
6

cell culture

Sanfield Clinic outsources cell culture to a “specified cell processing manufacturer” licensed by the Ministry of Health, Labor and Welfare in accordance with the “Act on the Safety of Regenerative Medicine, etc.”.
The adipose tissue collected from the patient is brought to the designated cell processing facility, where it is treated with enzymes and then the stem cells are isolated from the fat, cultured, and expanded. Cell culture is carried out under strict control.

To ensure a high level of safety, we conduct cell tests such as virus tests when the cells are brought in. Furthermore, to prevent mistakes in sample collection, cells are cultured under an operational management system that has introduced a strict quality control system, including history management for all processes.

~Cell safety = culturing in serum-free medium~
Some products labeled as serum-free medium contain serum-derived substances. These carry the same risks as serum use and may not be suitable for clinical use from a safety perspective. The culture medium used at Sanfield Clinic is completely serum-free, even in its secondary raw materials.
[Advantages of culturing in serum-free medium]
・Minimize the risk of pathogen infection
・Standardize the culture process
・Does not depend on serum, allowing for the preparation of a variety of cells
Additionally, while manufacturing-related products used in everything from adipose tissue dispersion to packaging of cell preparations typically contain human- and animal-derived ingredients, we have achieved manufacturing processes that are free of animal- and human-derived substances, at least up to the secondary raw materials.

Offered by Sunfield ClinicRegenerative medicine (stem cell therapy) provided by Sanfield Clinic

Autologous adipose-derived mesenchymal stem cell therapy for the prevention of arteriosclerosis progression

Currently, the average life expectancy is said to be 80 years, but the average “healthy life expectancy” – the period during which one can live a healthy life without any problems in daily life – is said to be 75 years. How to prevent disorders that occur with aging is very important in order to live out one’s life in good health. As the term “vascular age” suggests, vascular disorders are one of the common disorders that occur with aging.
It has recently become clear that chronic inflammation occurs throughout the body as a disorder associated with aging. It is also known that arteriosclerosis, a typical vascular disorder, is triggered by chronic inflammation. In other words, aging, chronic inflammation, and arteriosclerosis are closely related events.
The mesenchymal stem cells used in this treatment can be extracted from sources within the body, such as fat, bone marrow, and the umbilical cord. When the body is injured, mesenchymal stem cells gather at the site of injury to fill the wound and suppress swelling (inflammation). It has been discovered that mesenchymal stem cells extracted from the body can be cultured and multiplied, and then returned to the body, thereby suppressing various types of inflammation, and research and clinical trials are currently underway around the world.
It is now known that arteriosclerosis is also caused by chronic inflammation, so it is thought that suppressing inflammation by administering mesenchymal stem cells will lead to the improvement or prevention of arteriosclerosis.
Regenerative medicine etc. provided
Autologous adipose-derived mesenchymal stem cell therapy for the prevention of arteriosclerosis progression
Classification of regenerative medicine, etc.
Second type
Regenerative medicine provision plan number

PB3230222

Targeted Therapists
1) Those who are judged to have arteriosclerotic lesions based on the following selection criteria ① to ③:
① Pulse wave velocity (PWV) ≧ 1400 (cm/s) or CAVI (Ankle Brachial Index) ≧ 8.0
② ABI test (Ankle Brachial Index) ≦ 0.9
③ Carotid ultrasound: Those with plaque (IMT ≧ 1.1) in the carotid artery (common carotid artery, internal carotid artery)
2) Those aged 18 or older
3) Those who are physically fit and in good health to withstand fat collection
4) Those who have normal capacity to consent, or those who can obtain consent from a legal representative
5) Those who have been given a consent form for this treatment, have received a sufficient explanation, and have obtained written consent of the patient’s own free will (if the patient does not have the capacity to consent, a legal representative can provide written consent)
6) Those whose doctor in charge has determined eligibility based on interviews, tests, etc.
There are other inclusion and exclusion criteria, so please contact the clinic for details.
Treatment duration
After prior explanation and consent, from fat collection to stem cell administration: Approximately 8 weeks
*Follow-up examinations after stem cell administration (1, 3, 6, 12, 18, and 24 months after administration)
Time required for cell administration
40 to 60 minutes
Cost
Initial consultation fee: 50,000 yen (excluding consumption tax)
Treatment fee: 2,950,000 yen (excluding consumption tax)
Risks and side effects of treatment
During fat collection:
bleeding from the wound, subcutaneous bleeding at the fat collection site, pain, infection, and exudate at the wound, side effects of anesthetics (nausea, vomiting, cold sweats, palpitations, etc.)
During stem cell administration:
anaphylactic reaction, shock, pulmonary embolism, difficulty breathing, decreased blood pressure, increased blood pressure, headache, cold sweat, nausea, vomiting, abdominal pain, nerve damage, numbness in the fingers and toes, pain at the puncture site, internal bleeding at the puncture site, erythema, rash, itching, edema, liver dysfunction, fatigue, fever, etc.

Autologous adipose-derived mesenchymal stem cell therapy for chronic pain relief

People experience a variety of pains, including injuries, burns, and headaches. Many types of pain are caused by some kind of illness, and chronic pain is a condition in which a certain level of pain persists for a long period of time. It is said that one in four or five Japanese people suffer from chronic pain, such as lower back pain (commonly known as lumbago). However, current treatments are not sufficient to provide adequate pain relief.
This treatment uses stem cells called autologous adipose-derived mesenchymal stem cells. Mesenchymal stem cells are isolated and cultured from various tissues, such as bone marrow, fat, and the umbilical cord. They have the ability to accumulate at the site of the disease, and there have been a growing number of reports that they also have anti-inflammatory and immunosuppressive effects. In recent years, there has also been an increasing number of research reports that they are effective in alleviating pain. We have demonstrated that adipose-derived mesenchymal stem cells cultured using the same method as the cells used in this treatment also have anti-inflammatory and pain-relieving effects. It is believed that administering mesenchymal stem cells to patients suffering from chronic pain may make it possible to alleviate pain.
Regenerative medicine etc. provided
Autologous adipose-derived mesenchymal stem cell therapy for chronic pain relief
Classification of regenerative medicine, etc.
Second type
Regenerative medicine provision plan number

PB3230228

Targeted Therapists
1) People with chronic pain.
2) People who have not experienced satisfactory pain relief with other standard treatments for chronic pain, or who, despite fully understanding the standard treatments, do not wish to undergo treatment with the drugs used in standard treatments due to concerns about side effects,
etc. There are other inclusion and exclusion criteria, so please contact the clinic for details.
Treatment duration
After prior explanation and consent, from fat collection to stem cell administration: Approximately 8 weeks
*Follow-up examinations after stem cell administration (1, 3, 6, and 12 months after administration)
Time required for cell administration
40 to 60 minutes
Cost
Initial consultation fee: 50,000 yen (excluding consumption tax)
Treatment fee: 2,950,000 yen (excluding consumption tax)
Risks and side effects of treatment
During fat collection:
bleeding from the wound, subcutaneous bleeding at the fat collection site, pain, infection, and exudate at the wound, side effects of anesthetics (nausea, vomiting, cold sweats, palpitations, etc.)

During stem cell administration:
anaphylactic reaction, shock, pulmonary embolism, difficulty breathing, decreased blood pressure, increased blood pressure, headache, cold sweat, nausea, vomiting, abdominal pain, nerve damage, numbness in the fingers and toes, pain at the puncture site, internal bleeding at the puncture site, erythema, rash, itching, edema, liver dysfunction, fatigue, fever, etc.

If you are considering stem cell therapy, please contact our clinic first.
We will provide you with detailed information and explanations about the treatment.

FAQ

What are stem cells?
The bodies of all living things are made up of cells. There are approximately 60 trillion cells in the human body. Each cell has a specific role depending on its location.
A characteristic of stem cells is that they can produce cells that serve as the basis for other cells. When stem cells produce other cells, they divide into two. One of these divided cells remains as a stem cell, and the other cell becomes a cell that can transform into another cell. Stem cells create new cells in this way to replace damaged or old cells.
What is stem cell therapy?
This is a treatment method that uses stem cells to repair and regenerate damaged cells and tissues in patients.
Stem cells from the patient’s body are collected and mass-cultured at a CPC. After culturing, the stem cells may be administered into the bloodstream or transplanted directly into the affected area. For a detailed treatment procedure, please see Q.3 What is the process for stem cell therapy?
What is the process for stem cell therapy?
This is a treatment method that uses stem cells to repair and regenerate damaged cells and tissues in patients.
Stem cells from the patient’s body are collected and mass-cultured at a CPC. After culturing, the stem cells may be administered into the bloodstream or transplanted directly into the affected area. For a detailed treatment procedure, please see Q.3 What is the process for stem cell therapy?

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