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Diabetes Type 2 Stem Cell Treatment

16/04/2019

How Stem Cell Therapy can help treat patients with type 2 diabetesExpected resultsResults of Swiss Medica patientsHow and why stem cells work?Source of stem cellsWhat does the treatment procedure involve?Preliminary proceduresDurationYour comfort during the proceduresSafety of stem cell therapyRecovery after treatmentList of literature references

Cells of human beings obtain energy from sugar (glucose) which is produced from food or stored in the liver. Molecules of glucose are delivered to cells through the bloodstream. Diabetes is a common chronic disease that develops when cells fail to convert glucose into energy. Thus, the glucose level in blood increases – this is called hyperglycemia, which leads to negative consequences for the major systems of the body – heart, blood vessels, nerves, eyes, and kidneys. Type 2 diabetes also increases the overall likelihood of dying prematurely [1].

Normally, glucose blood levels are regulated by insulin, a hormone secreted by pancreatic beta cells. Type 2 diabetes develops when the pancreas cannot provide enough insulin or when the body cannot effectively use the insulin it produces. Type 1 diabetes is a much less common disease; it develops when the immune system cells destroy the pancreas beta cells, so insulin secretion significantly decreases.

Picture 1. Consequences of uncontrolled diabetes: High level of blood glucose (hyperglycemia) leads to many negative effects for major systems of the body – heart, blood vessels, nerves, eyes, and kidneys, as well as a higher risk of premature death [1] (excerpt from the WHO global report on diabetes, 2016).

Diabetes type 2. Consequences

Type 2 diabetes is usually diagnosed after age 45, however, it is being increasingly diagnosed in children and younger adults [2]. Excessive weight and physical inactivity are the main risk factors for type 2 diabetes [1]. The disease begins gradually; at the early stages, a patient may feel fine. Elevated blood glucose can be revealed accidentally when the patient is examined for another reason. These are major signs and symptoms that should draw your attention as possible signals of diabetes:

  • enhanced thirst and frequent urination;
  • increased hunger;
  • unintentional weight loss;
  • a feeling of tiredness;
  • blurred vision;
  • indolent wounds;
  • frequent infections;
  • areas of darkened skin, usually in the armpits and neck.

Picture 2. Signs of diabetes. If you notice these signs, please contact your doctor and have your blood glucose levels tested.

Signs of diabetes

How stem cell therapy can help treat patients with type 2 diabetes

Scientists have not yet found a cure for type 2 diabetes. All efforts are currently focused on controlling the glucose level. It is recommended that those suffering from type 2 diabetes maintain a healthy diet and body weight, and exercise regularly to manage the disease. If diet and exercise aren’t enough to control blood glucose levels well, the patient may also need diabetes medications or insulin therapy.

Researchers have been developing and adopting different stem cell approaches to treat diabetes since the early 1990s [3]. Recent studies have demonstrated the promising results of using bone marrow mononuclear cells (MNC) and multipotent mesenchymal stem cells (MMSCs), including preserving the function of beta-cells, significant decreases of insulin dosage, and improved regeneration in patients with diabetic foot ulcers [4], [7], [8].

Table 1. Clinical trials using bone marrow hematopoietic and mononuclear cells to treat type 2 diabetes mellitus. (BM-MNC: bone marrow mononuclear cells; IV: intravenous; MSC: mesenchymal stem cells) [4].

Type 2 diabetes. Clinical trials

Table 2. Clinical trials using mesenchymal stem cells to treat type 2 diabetes mellitus. (IV: intravenous) [4].

Type 2 diabetes. Clinical trials2

Expected results

The results of stem cell therapy have been evaluated by both objective and subjective measures. Most of the patients treated with MMSC injections show stable improvement of the following signs and symptoms of the disease:

  • disappearance/reduction of clinical symptoms (normal blood glucose, control of appetite and weight, etc.);
  • insulin dose reduction or oral hypoglycemic drug dose reduction;
  • a decrease in fasting blood glucose;
  • increased serum C-peptide;
  • a lower concentration of glycated hemoglobin;
  • improvement in the quality of life (assessed using a specialized questionnaire SF-36 [5]).

In cases of diabetic ulcer treatment with MMSC injections, the following results may be achieved:

  • disappearance/reduction of clinical symptoms (normal blood glucose, control of appetite and weight, etc.);
  • reduction of the ulcer size (in both radius and depth, if applicable);
  • complete healing of the ulcer;
  • increased transcutaneous oxygen tension in the ulcer;
  • increased ankle-brachial index in the ulcer;
  • improvement in the quality of life (assessed using a specialized questionnaire SF-36 [5]).

Results of Swiss Medica patients

This is the story of a Swiss Media patient from Indonesia: Wahyudin visited the Swiss Medica clinic in Moscow in December 2017 for the first time to receive treatment for type 2 diabetes. Before the treatment, his glucose level was above 200-250 mg/dL (normal range is 79 to 110 mg/dL). The treatment he received involved both IMR therapy and Stem Cell Therapy.

The first visit to Swiss Medica resulted in changes to his lifestyle and diet – he was able to better control his appetite and ended up losing 4.5 kilos. Blood sugar monitoring showed a stable level at about 120-140 mg/dL, and sometimes even below 100 mg/dL. Even when Wahyudin ate some unhealthy food, his glucose levels only increased to just above 140 mg/dL, which is considered under control.

After 6 months, Wahyudin went to Moscow again to receive the second treatment course. At the time of this visit, the procedure involved the use of autologous adipose tissue MMSC therapy and autologous bone marrow mesenchymal stromal fraction cells therapy. As a result, his weight dropped by another 2 kilos, his glucose levels decreased to 100-120 mg/dL, his diet became more stable and he is now able to control his appetite more effectively. The unexpected benefit of the treatment was an improvement to his vision, starting from the first treatment course – thanks to the stem cell treatment, he became able to drive a car during daytime and work on a computer without glasses.

How and why stem cells work in the treatment of type 2 diabetes

Multipotent MSCs can reduce hyperglycemia in type 2 diabetes primarily by stimulating the regeneration of beta cells through several mechanisms:

  1. The activation of pancreas progenitor cell differentiation and an increase in the number of beta cell precursors [4].
  2. The pro-angiogenic activity of MMSCs, which leads to increased vascularization of the pancreatic islets (regions of the pancreas that contain endocrine cells — which are hormone-producing cells) and general improvement of its endocrine function.
  3. And the immunomodulatory effect, which plays a crucial role in the presence of an autoimmune component in the development and persistence of diabetes, and is an important part of the complex effects of MMSCs [6].

When curing diabetic ulcers, the main goal is to restore adequate blood circulation in the area of the ulceration and reduce ischemia. MMSCs activate resident cells and attract circulating progenitor cells. They also induce new vascular growth from existing capillary networks. As a result, nutrient and oxygen supply is restored, which leads to the stimulation of ulcer epithelization. The ability of MMSCs to stimulate the development of capillary networks and the subsequent increase in blood flow helps to improve one of the most serious complications of type 2 diabetes: generalized microvascular dysfunction. The hypoglycemic effect of the MMSCs contributes to the healing of ulcerative skin lesions in patients with diabetes. Local injections of MMSCs directly around the wound further improves the efficiency of the cell product, helping to accelerate the healing of lesions [7].

Source of stem cells used in the treatment of type 2 diabetes

Multipotent MSCs can be obtained both from the patient’s own tissues (bone marrow, adipose tissue, peripheral blood or oral mucosa) or from donor sources (placenta, umbilical cord, etc).

What does the treatment procedure involve?

The treatment procedure occurs in the following stages which typically take several weeks:

  1. Collection of cell product – the source of MMSCs;
  2. Cell processing and cultivation to obtain the required number of MMSCs (this is the most time-consuming step which lasts about 4 weeks) and;
  3. The injection of MMSCs.

When donor cells are used in the treatment, the second step is excluded. Cell material may be prepared in advance from frozen (cryopreserved) and MMSCs can be ready within 24 hours.

Preliminary procedures

Prior to the procedure, a doctor from Swiss Medica will examine the patient and determine their current state of health and individual characteristics, collecting all the available data from their medical history to determine the feasibility and possibility of conducting stem cell therapy using MMSCs. Laboratory and/or instrumental tests are performed so that the specialist can determine the most suitable source of autologous MMSCs (bone marrow, adipose [fat] tissue or gingival tissue).

In the operating room, the doctor prepares the patient’s skin by cleaning with an antiseptic and then administering local or general anesthesia. Following this, the sampling of biological material is performed.

Bone marrow samples are usually collected from the top ridge of the back of a hipbone or sometimes from the front of the hip.

Adipose tissue is harvested in the area of the anterior abdominal wall, side surfaces of the waist, loins, buttocks, and/or the outer side of the hips.
Gingival tissue stem cell samples are obtained by the surgeon cutting 3-4 mm3 of the gum.

Duration

The bone marrow collection takes about an hour on average.

Harvesting of adipose-derived SVF cells takes about 30 minutes and varies depending upon the amount of tissue aspirated from the patient.

Collecting cells from gingival tissue is also a relatively brief procedure.

The patient is monitored after the collection of MMSCs to ensure their safety.

Your comfort during the procedures

You may feel some pain similar to the sensation from an ordinary injection while the doctor introduces an anesthetic drug (in the case of own cells being harvesting or of local cell product injections).

Safety of stem cell therapy

The key safety issue with stem cell therapy is a possible malignant transformation (i.e. risk of cancer). Clinical trial results confirmed that there is no scientific evidence that MMSCs may potentially spontaneously transform when proper quality control of cell cultivation and the injection is ensured [8], [9]. Local injections of stem cells have also exhibited a very safe profile. The procedures are usually well tolerated in the majority of patients. However, individual intolerance, though rare, cannot be excluded. Swiss Medica specialists will monitor your condition to assure a safe and beneficial result. They will also take appropriate measures to mitigate any possible risks.

Recovery after treatment

Patients may feel some pain in the place where stem cells were collected. To clarify the effectiveness of MMSC transplantation and the decision to reintroduce the cell product, patients undergo a routine examination after 3 and 6 months after the stem cell injection. Mandatory examinations include a physical examination, collection of medical history and a panel of laboratory and instrumental tests, which are performed to assess the results of the stem cell therapy.

If you have any questions about the treatments procedures and using stem cell to manage diabetes type 2, please contact our Medical Advisor. You can discuss your individual case with a specialist of the Swiss Medica clinic.

– Published on April 16, 2019 by

Eremin Ilya Igorevich,

Vice Director for Science and Research,

MD, PhD;

Senior Research Associate at the Laboratory for Cellular Biology and Developmental Pathology at the Institute of General Pathology and Pathophysiology;

Associate Professor of the Department of Regenerative Medicine and Biomedical Technology at A.I. Yevdokimov Moscow State University of Medicine and Dentistry;

Member of the Department of Plastic and Reconstructive Surgery, Cosmetology and Cellular Technologies (Pirogov Russian National Research Medical University);

Member of International Federation for Adipose Therapeutics and Science (IFATS);

Member of International Society for Cellular Therapy (ISCT);

Member of International Society of Plastic & Regenerative Surgeons (ISPRES);

Member of Cell Society;

Member of International Society for Stem Cell Research (ISSCR);

Member of International Placenta Stem Cells Society (IPLASS);

Author and co-author of more than 120 scientific articles, and co-author of 6 patents of invention.

List of literature references:

[1]. World Health Organization. Diabetes. 2018.

[2]. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), USA.

[3]. National Institutes of Health, USA.

[4]. Li LHH et al. Infusion with human bone marrow-derived mesenchymal stem cells improves β-cell function in patients and non-obese mice with severe diabetes. Sci Rep. 2016;6:37894.

[5]. 36-Item Short Form Health Survey questionnaire.

[6]. Wang Y et al. Plasticity of mesenchymal stem cells in immunomodulation: pathological and therapeutic implications. Nat Immunol. 2014;15 (11):1009-16.

[7]. Cao Y et al. Mesenchymal stem cells improve healing of diabetic foot ulcer. J Diabetes Res. 2017;2017:9328347.

[8]. Bhansali A et al. Efficacy and safety of autologous bone marrow-derived stem cell transplantation in patients with type 2 diabetes mellitus: a randomized placebo-controlled study. Cell Transplant. 2014;23(9):1075-85.

[9]. Liu X et al. A preliminary evaluation of efficacy and safety of Wharton’s jelly mesenchymal stem cell transplantation in patients with type 2 diabetes mellitus. Stem Cell Res Ther. 2014;5(2):57.

 

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