Stages of Stem Cell Treatment

Treatment with Stem Cells is carried out in several stages

 1. The collection of biomaterials for the isolation of Stem Cells

2. Cell processing and cultivation to obtain the required number of Stem Cells.

3. The procedure of Stem Cell transplantation into the patient’s body

The first stage is the collection of biomaterials for the isolation of Stem Cells.

 When allogeneic (donor) Stem Cells are used:

 In treatment programs can be used Multipotent Mesenchymal Stem Cells (MMSCs) from the placenta and umbilical cord and Hematopoietic cord blood Stem Cells (СВHSCs )

Until the moment of treatment, the Stem Cell biomaterial that was previously subjected to cryopreservation (freezing with liquid nitrogen) is stored in our specialized certified biobank.

Before use, biological cell material is checked for compliance with several indicators, including:

● sufficient percentage of viable cells;

● the purity against DNA viruses;

● sterility against bacteria and microscopic fungi.

As needed, the cells are thawed and cultivated to reach the therapeutic dose. After the cell product is prepared, it is transplanted to the patient – intravenously, intramuscularly, or directly into the affected area.

Ready-made cell products based on placenta-tissue-derived Stem Cells are obtained by a non-invasive method and can be utilized immediately by medical indications. For the patient, there is no need for a long and painful procedure to harvest a portion of their cells for cultivating. Donor cells are always available in our certified biobanks. They are selected individually for the patient in advance; thus, we can immediately begin the treatment procedure on the first visit to the clinic.

 When autologous (own) Stem Cells are used:

 The most common source of Stem Cells for treatment is the bone marrow. But it can also be effectively extracted from adipose tissue.

If qualified specialists perform it with absolute sterility, bone marrow sampling or aspiration is a fast and safe procedure. The fence is made from the hip bone of its posterior-upper ridge. This is in the lateral region of the lower back. The procedure does not require General anaesthesia and is performed under local anaesthesia with an anaesthetic drug, which the doctor inserts into the tissue after careful treatment of the fenced area with antiseptics.

 To extract adipose tissue in the operating room under local anaesthesia, the doctor will take a small amount of adipose tissue (about 60 ml) for Stem Cell isolation. Adipose tissue is taken from the anterior abdominal wall near the navel with a special syringe without incisions, scars, and cosmetic defects. The patient can then remove the bandage the next day.

 We use a special needle that facilitates the procedure and does not damage the Stem Cells during aspiration, taking an average of 200 ml of bone marrow. Then our specialist transfers it to special sterile tubes, and our service transports it to the laboratory for further processing, isolation, and growth of Stem Cells to the required amount for treatment. A specialist applies a sterile aseptic dressing, and a sterile aseptic dressing is applied to the area where the biomaterial is collected. The procedure lasts 20-25 minutes. It is painless, and only the appearance of pulling sensations when inserting and removing the aspiration needle is possible. Perhaps the only complication of the sampling procedure may be the formation of a subcutaneous hematoma (bruise), which disappears independently without requiring specific therapy. Usually, the patient remains under observation in the clinic for 1 day, and after a final examination by specialists, they can go home.

 Cell processing and cultivation to obtain the required number of Stem Cells

 The second stage: cell processing and cultivation. This is the growth of Stem Cells in a cell laboratory according to the standard of GMP and GLP to the required amount for treatment. This is the most important stage since cell therapy results depend on the grown cells’ quality. The number of cells depends on the age and body weight of the patient, but usually, it is at least 1 million cells per kilogram of body weight. On average, it is produced 21 days after collecting the biomaterial. During this time in the laboratory, cells are built up to the amount necessary for treatment in a natural way without the use of stimulants that change the structure and properties of Stem Cells.

 The procedure of Stem Cell transplantation into the patient’s body

 The third stage: the procedure of Stem Cell transplantation into the patient’s body.

There are 4 main ways to introduce Stem Cells into the patient’s body :

1. intravenous

2. intrathecal

3. intranasal.

4. local (optional)

 

1. The intravenous way of administration ensures the penetration of Stem Cells with blood flow to all organs and tissues of the body that are weakened by the disease. They cause the normalization of the functioning of all body systems, thereby significantly improving the patient’s overall condition.

There is no necessity to use immunosuppressive therapy before intravenous transplantation of Stem Cells because regardless of their source, autologous (i.e. own) or donor allogeneic (i.e. donor), all Stem Cells have immunomodulatory and immunosuppressive properties. In treating heart diseases, Stem Cells are introduced by intravenous infusion (dropper). The doctor, in each case, determines the number of cells and frequency of injection procedures. The procedure usually takes 40-45 minutes. It is performed under the supervision of specialists and constant monitoring of blood pressure, pulse, heart rate and respiration, temperature, and General condition of the patient.

When administered intravenously, Stem Cells with blood flow reach the damaged area of the tissue. In the affected area, they are fixed, cause the formation of a whole cascade of regenerative processes and stimulate the formation of new healthy cells. Also, clinical studies have found that the introduced Stem Cells can be modified (differentiated) into other cells of the organs and tissues. By modification, Stem Cells are embedded between the cells of the damaged tissues, thereby replacing all the affected areas. This restores body functioning and leads to the reverse development of disease symptoms.

2. The intrathecal way of administration: Stem Cells are injected directly into the spinal space of the vertebral column. Thus, with the current of cerebrospinal fluid, they penetrate the blood-brain barrier and are fixed directly in damage to the brain and motor neurons. There, they stimulate the central nervous system’s regeneration processes, slow the disease’s progression, and in some cases restore lost functions. The introduction of Stem Cells into the spinal space slows down the process of destruction of motor neurons and promotes partial restoration of the structure of the spinal cord. Replacing dead neurons, Stem Cells reduce symptoms and improve motor disorders, without causing a negative immune response in the body.

3. The intranasal way is the introduction of Stem Cells and exosomes (concentration of regenerative substances that produce Stem Cells) to the patient by inhalation. In this way, the introduction of Stem Cells and exosomes penetrates directly into the brain through the vascular network of the nasal sinuses. The method can be used for the correction of cognitive manifestations of the disease: it improves behavioral responses, speech, attention, mood, sleep, social adaptation, and most importantly, it is very well tolerated by patients.

4. The local route of administration (optional) is the introduction of Stem Cells directly into the damaged area (joints, muscles, skin, etc.). This is achieved by injection of Stem Cells or their introduction with the help of physiotherapy (electrophoresis)