Stem cell therapy for diabetes mellitus | Overview including symptoms and causes

Diabetes mellitus is a disease in which the level of blood sugar remains elevated owing to a decrease in the ability to maintain normal blood sugar levels. With the aging of the population and lifestyle changes, lifestyle-related diseases including diabetes mellitus are increasing worldwide. While medication, diet therapy, and exercise are generally used to slow disease progression, “stem cell therapy” has attracted attention as a type of regenerative medicine in recent years.
In this article, we explain the basic mechanism, symptoms, and causes of diabetes mellitus and introduce stem cell therapy, focusing on its advantages and treatment flow. We provide useful information for those who are anxious about their long-term relationship with diabetes mellitus and for those who are looking for new treatments.

What is diabetes mellitus?

Diabetes mellitus is a condition characterized by chronically high blood sugar level (blood glucose concentration) due to insufficient insulin secretion or action. Japan is estimated to have more than 20 million patients, including at-risk individuals, and diabetes mellitus is recognized as a major medical and social security issue.
Diabetes mellitus is generally divided into the following types:

• Type 1 diabetes mellitus: β cells in the pancreas are destroyed by autoimmunity, and as a result, almost no insulin is produced. Onset is early in life in many cases, often requiring lifelong insulin injections.
• Type 2 diabetes mellitus: A combination of lifestyle habits such as diet, lack of exercise, and obesity and genetic predisposition result in insufficient insulin secretion and action, leading to elevated blood sugar levels. Approximately 90% of Japanese patients with diabetes mellitus reportedly have type 2 diabetes mellitus.

*1

Insulin is a hormone that plays a role in the uptake of glucose from the blood into cells. If insulin is insufficient or its action is not smoothly exerted, the blood sugar level cannot be controlled, which results in a chronic hyperglycemic state.
*1 Reference: Diabetes and Metabolism Information Center

Symptoms of diabetes mellitus

The early stages of diabetes mellitus have almost no subjective symptoms; often, the condition is discovered only after an abnormal blood sugar level is detected in a blood test during a health checkup. However, if the hyperglycemic state persists, the following symptoms may occur.

• Polyuria and thirst: When the glucose level is too high, the kidneys excrete sugar, resulting in increased urine output and increased thirst.
• Malaise and fatigue: Difficulty in cellular uptake of glucose, which is an energy source, renders the patient more prone to chronic fatigue.
• Weight loss: Insulin insufficiency can prevent nutrients from reaching the cells, possibly resulting in body fat and muscle breakdown and weight loss.
• Decreased visual acuity and blurred vision: High blood sugar levels may cause abnormalities in the lens and retina, leading to visual impairment.
• Skin troubles and infections: Decreased immunity and poor blood circulation may increase the risk of dermatitis, impaired wound healing, and periodontal disease.

Diabetes mellitus can cause complications (including retinopathy, nephropathy, and neuropathy) as symptoms progress, and severe symptoms can significantly impair the patient’s quality of life (QOL). *2

*2 Reference: Diabetes and Metabolism Information Center

Causes of diabetes mellitus

Diabetes mellitus (mainly type 2) is believed to occur as a result of a combination of lifestyle and genetic factors. Major factors include the following:

• Excessive energy intake or obesity: Continued intake of too many calories or a diet high in fat leads to an increase in insulin resistance, rendering it difficult to lower blood sugar levels.
• Lack of exercise: When muscle mass decreases, energy consumption also decreases, and as insulin resistance increases, blood sugar control is easily disrupted.
• Genetic predisposition: If parents or siblings have diabetes, the risk of developing the disease increases.
• Stress and aging: Effects of stress hormones and age-related decline in the body functions may interfere with the action of insulin.

In addition, since type 1 diabetes mellitus is caused by autoimmunity-induced destruction of β cells in the pancreas, its causes and treatment methods differ from those of type 2 diabetes mellitus. *3
*3 Reference: Diabetes and Metabolism Information Center

Stem cell therapy as a promising radical treatment for diabetes mellitus

Traditionally, the treatment of diabetes mellitus has centered on drug therapy (e.g., oral antihyperglycemic drugs, insulin injections) and lifestyle modification. These are mostly symptomatic therapies to maintain blood sugar control. In recent years, stem cell therapy has been suggested to restore, at least partly, the ability of the pancreas to produce insulin, and it is attracting attention as a means to achieve fundamental improvements.

What is stem cell therapy?

Stem cell therapy is an area of regenerative medicine that aims to regenerate and repair damaged or functionally impaired tissues using stem cells, which have the ability to both self-renew and undergo multilineage differentiation. In stem cell therapy for diabetes mellitus, an approach to promote cell regeneration and tissue repair using stem cells has been studied and practiced to compensate for the decreased function of insulin-secreting pancreatic β cells. In general, stem cells are harvested from various parts of the human body or umbilical blood, bone marrow, and adipose tissue; cultured and grown; and then administered to the affected area. Stem cells differentiate and proliferate at the sites where they are introduced in the body and support the suppression of inflammation and recovery of cell function.

Advantages of stem cell therapy

Stem cell therapy in diabetes mellitus is believed to display the following advantages:

• Improvement of insulin secretion as a possible goal: The administered stem cells may supplement insulin-producing cells and enhance the quality of blood sugar control.
• Reduced risk of complications: Stabilization of blood sugar levels may stop disease progression to complications such as retinopathy, nephropathy, and neuropathy.
• Alleviation of drug dependence: If symptoms improve, insulin injections and the doses of oral medications may be reduced.

However, similar effects cannot be expected in all patients, and treatment results vary according to the time of onset, disease type, and individual differences.

Reasons why stem cell therapy is effective

In addition to the ability to differentiate, stem cells secrete growth factors called cytokines and support tissue repair and angiogenesis. For this reason, a possibility exists that stem cells may act in a multifaceted manner on the pancreas with damaged insulin-secreting cells and help restore its function.
In addition, stem cells are believed to have immunomodulatory effects, and attention has been drawn to their ability to exert an anti-inflammatory effect on the site of inflammation. Future research may expand indications, possibly for the pathological condition of type 1 diabetes involving autoimmune factors.

Flow of treatment at the Regenerative Medicine Division of Korokai Medical Corporation

At the Regenerative Medicine Division of Korokai Medical Corporation, the following steps are taken when administering stem cell therapy for diabetes mellitus.

• Initial consultation and screening: We will check the patient’s medical history, blood sugar level, and presence or absence of complications to determine whether or not stem cell therapy is appropriate.
• Stem cell collection and culture: Stem cells will be extracted from autologous sources such as fat and bone marrow, and grown and cultured in a clean room, checking safety.
• Preparation of the administration plan: The frequency and method (e.g., intravenous infusion) of stem cell administration will be determined according to the disease state and wishes of each patient.
• Stem cell administration and follow-up: In practice, after stem cell administration, blood sugar levels, HbA1c, and any complications will be monitored regularly, and the treatment plan will be modified as needed.

Possibility of treating diabetes mellitus with stem cells

Diabetes mellitus is a challenging condition where impaired control of blood sugar levels can increase the risk of complications. Conventional treatment measures are mainly based on lifestyle modification and drug therapy; however, these have fundamental limitations as a means to recover insulin secretion. Under such circumstances, stem cell therapy has been investigated and clinically applied as a new approach to recover decreased pancreatic function or improve the body’s internal environment. The Regenerative Medicine Division of Korokai Medical Corporation proposes stem cell therapy tailored to the pathological condition of each patient and works to improve blood sugar control and prevent complications. If you are worried about the progression of diabetes mellitus or you have not had an adequate response to treatments thus far, you may consider stem cell therapy as a new treatment option.

The Regenerative Medicine Division of Korokai Medical Corporation offers stem cell-based regenerative medicine as a medical institution approved by the Ministry of Health, Labour and Welfare. *4

If you are interested in stem cell therapy, please contact our hospital for consultation.
The Regenerative Medicine Division of Korokai Medical Corporation carefully selects evidence-based treatment and offers regenerative medicine according to each individual’s concerns based on novel comprehensive treatment strategies. To optimize the results, a combination of oral therapy, such as bioidentical hormone replacement therapy or peptide therapy, and stem cell therapy will be used.

*4 Source:Ministry of Health, Labour and Welfare

 

The Regenerative Medicine Division of Korokai Medical Corporation – a stem cell therapy clinic in Tokyo

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[1] Therapeutic Method
The treatment involves harvesting and culturing stem cells from the patient’s adipose tissue and then injecting them locally at the affected area or administering them via intravenous infusion.
[2] Risk of side effects
At the time of fat collection: Adverse reactions such as internal bleeding, swelling, postoperative infection, postoperative scar, and pain at the injection site may be observed.
At the time of stem cell administration: Adverse reactions such as pain at the injection site, allergic reaction, and pulmonary embolism may be observed.
[3] Contact information
The Regenerative Medicine Division, Korokai Medical Corporation
5th floor, Precious 18, 4-14-6 Minami-Azabu, Minato-ku, Tokyo
TEL:03-6277-4650
[4] Pricing
This treatment is a private therapeutic strategy that is not covered by public health insurance.
For culture of approximately 100–180 million stem cells
*Since the number of stem cells that can be grown varies from person to person, it may be less than 100 million stem cells.
1 cycle costs 2.5 million yen (tax included)
3 cycles cost 7.2 million yen (payment in installments: 2.5 million yen each for the first and second cycles, 2.3 million yen for the third cycle)
5 cycles cost 11.5 million yen (tax included) (payment in installments: 2.5 million yen each for the first through fourth cycles, 1.5 million yen for the fifth cycle)
For culture of approximately 200–280 million stem cells
*Since the number of stem cells that can be grown varies from person to person, it may be less than 200 million stem cells.
1 cycle costs 3.8 million yen (tax included)
3 cycles cost 11.1 million yen (tax included) (payment in installments: 3.8 million yen each for the first and second cycles, 3.5 million yen for the third cycle)
5 cycles cost 17.5 million yen (tax included) (payment in installments: 3.8 million yen each for the first through fourth cycle, 2.3 million yen for the fifth cycle)
Please consult us for further details.
[5] Route of acquisition
Stem cells will be cultured at the affiliated CPC.
[6] Presence or absence of devices/drugs approved for the indications in Japan
No approved drugs for the indications are available in Japan.
[7] Safety information from other countries
There are no reports on safety in other countries.
*Significant risks may not have been identified.
[8] The fact that it has not been approved
Drugs used in this treatment are yet to receive approval in accordance with the Pharmaceutical and Medical Device Act.
[9] Unapproved drugs/devices
Public aid systems (such as Relief Systems for Adverse Drug Reactions and Infections Acquired through Biological Products) are not applicable to unapproved drugs and devices.
[10] Notification of regenerative medicine provision plans
To perform this treatment, we have submitted the notification of regenerative medicine provision plans to the Ministry of Health, Labour and Welfare in accordance with the Act on the Safety of Regenerative Medicine.
Ministry of Health, Labour and Welfare, Class 2 Regenerative Medicine Provision Plan No. PB3210146
Ministry of Health, Labour and Welfare, Class 2 Regenerative Medicine Provision Plan No. PB3230187
Ministry of Health, Labour and Welfare, Class 2 Regenerative Medicine Provision Plan No. PB3240017
Ministry of Health, Labour and Welfare, Class 2 Regenerative Medicine Provision Plan No. PB3230218