Diabetology

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The goal, principle and scheme of the medical therapeutic experiment:

A medical therapeutic experiment is a multi-stage procedure aimed at applying an innovative method of treatment, technology or an innovative therapeutic preparation, which is not a standard therapy for a given illness. The medical therapeutic experiment is an alternative for patients who have not yet been treated or previous treatment has not produced the desired therapeutic effects. The main goal of the medical therapeutic experiment is to improve the patient’s health. The use of MSC therapy as part of a medical therapeutic experiment must always be supported by the consent of the Bioethical Commission at the District Medical Chamber in Częstochowa, Poland.

What are stem cells obtained from Wharton jelly?

Wharton’s jelly-derived mesenchymal stem cells – WJ-MSC are a population of multipotent stem cells, located in the umbilical cord, classified as gelatinous connective tissue.
Wharton jelly is made up mainly of mucopolysaccharides, including hyaluronic acid and chondroitin sulphate.
The mesenchymal stem cells used in the experiment have a fibroblast structure, show adhesion to plastic substrates and originate from unrelated and incompatible in the antigen range of tissue compliance and the main groups and Rh blood factor, donor.

Title of the medical therapeutic experiment:

“The use of mesenchymal cells obtained from a Wharton jelly incompatible donor unrelated to the treatment of patients with type 1 diabetes”.

Who can take part in a medical therapeutic experiment in the field of diabetology?

• Type I diabetes – Insulin dependent diabetes is one of the etiopathogenic forms of diabetes. Its underlying disease is a chronic, autoimmune disease process leading to the slow destruction of β-cells of the pancreatic islets (islets of Langerhans) and, consequently, the loss of its ability to secrete needed peptide hormone. The disease is treated by administering throughout the life of the patient peptide hormone with a short duration of action to meals consumed during the day, as well as with a long-acting, no-effect analogue – the so-called base (slowly absorbed in the suspension, which is administered once a day – most often before the second supper) .The treatment requires from the patient several subcutaneous injections of the drug in solution, as well as systematic, repeated determination of the level of glucose in the blood. This is a model of functional intensive therapy, necessary for the normal functioning of the patient.

Symptomatic type 1 diabetes, if not treated with injections, is a fatal disease. Comprehensively treated has a moderate impact on the expected life expectancy of a sick person.

General criteria for the selection of patients receiving therapy using WJ-MSC (Wharton’s jelly mesenchymal stem cells – Wharton jelly stem cells).

• patients of both sexes,
• age range: from 3 to 85,
• the obligation to use contraception during the course of therapy (applies to women).

Exclusion criteria from therapy:

• pregnancy and breast-feeding,
• severe or acute organ damage,
• an infectious disease, e.g. HIV, HBV, HCV, HPV,
• active infection requiring treatment,
• severe mental disorders,
• presence of malignant tumor,
• unstable state of the cardiovascular system,
• allergy to some antibiotics.

How can you qualify for MSC Therapy?

Patients are asked to send the following documents:

• hospital treatment information with confirmation of diagnosis: type I diabetes
• indication of at least one autoantibody associated with diabetes (anti-GAD or anti-IA-2)
• FGB – fasting blood glucose
• hemoglobin level
• creatinine level
• Peptide C
• daily insulin requirement
• HbA1C
• certificate from a cardiologist – in regards to the cardiorespiratory capacity
• Quality HCV RNA, borrelia IGG and IGM by western-blot, anti HBs, HIV
• Hepatitis B vaccination record

to the following address: komorki@cm-klara.pl or by post: Centrum Medyczne Klara, MSC Therapy, ul. Wał Dwernickiego 43/45, 42-202 Częstochowa, Poland where initial verification will take place.

After doctor qualification for MSC Therapy, Klara Medical Center acts on behalf of the Patient for the Bioethical Commission at the District Medical Chamber in Częstochowa, Poland.

At this stage, patients wait for the application to be reviewed by the Bioethical Commission.

In the case of a positively examined application, Klara Medical Center contacts the patient in order to provide information on:

• application dates
• the cost of therapy
• additional tests required
• organizational information

Diagram of a medical treatment experiment:

As part of the approval of the Bioethical Commission, the patient can receive up to 10 administrations of MSC. The duration of therapy is about 1.5 years.

• The interval between single administrations is 4-6 weeks – assessment of the treatment effect before each single injection.
• After the fifth administration of MSC, the patient starts a 6-month break, unless there are medical grounds for continuing therapy without taking into account the interruption.
• After the end of the 6-month interval, the therapy is resumed for a further 1-5 applications at intervals of 4-6 weeks or once every three months, if the patient’s condition has improved – assessment of the treatment effect before each single injection.
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Frequently Asked Questions:

• How long is the hospitalization at Klara Medical Center?

The patient spends 3 days in the hospital.
Day 1 – admission to the ward
Day 2 – administration of the MSC preparation
Day 3 – hospital discharge in the morning hours

• Can a parent / guardian or family member stay with the patient while in the hospital?

Yes, the cost in included.

If you would like to receive more information about stem cells treatment, please contact us at:

komorki@cm-klara.pl and / or +48 34 534 5003