Stages of Stem Cell Biotherapy
This article describes every stage of stem cell biotherapy in detail.
ADVANCED MEDICAL TECHNOLOGIES
What Is Regenerative Stem Cell Biotherapy?
The stem cell procedure is carried out in several stages:
1. Collecting biomaterial to isolate stem cells.
2. Processing and culturing to obtain the necessary quantity of stem cells.
3. The procedure to transplant the stem cells into the body.
First stage — collecting biomaterial to isolate stem cells.
Our programs may use donor (allogeneic) or the patient's own (autologous) stem cells.
When using allogeneic (donor) stem cells, the stem cell biomaterial (umbilical cord blood, mesenchymal stem cells from the placenta and umbilical cord) is stored in a specialized, certified biobank until it is needed.
Before use, the stem cell biomaterial undergoes double-checked testing against several criteria, including:
● the required percentage of viable stem cells;
● biological purity: testing for complete sample sterility (the absence of viruses, bacteria, and other infectious agents)
If needed, the stem cells are cultured (grown) until reaching a therapeutic dose. Once the stem cell biomaterial has passed testing, it is transplanted into the patient — intravenously, intramuscularly, into the spinal canal, or directly into the affected area.
One major advantage of using donor stem cells is that they're obtained in a way that's noninvasive for the patient — the patient doesn't have to go through the discomfort of having their own biomaterial collected and isn't exposed to general anesthesia. The absence of anesthesia, and the possible depressive effect it can have on the brain, is especially important for patients with neurological conditions. There are also no surgical risks associated with collecting biomaterial — particularly bone marrow, where damage or impaired function can lead to irreversible health consequences.
Another major advantage is that donor cells are always available from certified biobanks. They are selected individually for the patient in advance, so treatment can begin right at the patient's first clinic visit.
When using autologous (the patient's own) stem cells: the most common source of stem cells is bone marrow, but they can also be effectively extracted from adipose tissue.
When performed by qualified specialists under strict sterile conditions, bone marrow collection (aspiration) is a fast, safe procedure. The biomaterial is collected from the posterior superior iliac crest of the pelvic bone, in the lateral lower back area. The procedure is performed under general anesthesia (if indicated) or local anesthesia, which the doctor administers into the tissue after thoroughly disinfecting the area with antiseptics.
To extract adipose tissue, the doctor performs the procedure in an operating room under local anesthesia, taking a small amount of fat (around 60 mL) to isolate stem cells. The tissue is collected from the front of the abdomen near the navel using a special syringe, with no incisions, scarring, or cosmetic defects. The patient can remove the bandage the next day.
A special needle is used for collection that makes the procedure easier and doesn't damage the stem cells during aspiration, typically drawing about 200 mL of bone marrow or 60 mL of adipose tissue. The biomaterial is then transferred into special sterile tubes and sent to the lab for further processing, isolation, and expansion of the stem cells to the quantity needed for treatment. The doctor applies a sterile aseptic dressing to the collection site. The procedure takes 20–25 minutes and is painless, though a pulling sensation may occur as the aspiration needle is inserted and withdrawn. The only real complication that can occur is a subcutaneous hematoma (bruise), which resolves on its own without specific treatment. The patient is typically monitored at the clinic for 1 day and can go home after a final check-up with our specialists.
Second stage: processing and culturing the cells.
This is the growing of stem cells in a cell laboratory following the GMP and GLP standard, up to the quantity needed for treatment. This is the most important stage, since the quality of the cultured cells determines the outcome of the cell therapy. The number of cells needed depends on age and body weight, but is typically at least 1 million cells per kilogram of body weight. On average, the patient's own (autologous) cells take 28–30 days to prepare after biomaterial collection. During this time, the lab expands the cells naturally to the quantity needed for treatment, without using stimulants that would alter the structure and properties of the stem cells.
Donor biomaterial usually already contains the necessary quantity of stem cells ready for use.
Third stage: the procedure to transplant stem cells into the patient's body.
There are 4 main methods of administering stem cells:
1. Intravenous
2. Intrathecal
3. Intranasal.
4. Local (if indicated)
1. Intravenous route of administration delivers stem cells via the bloodstream to every organ and tissue weakened by the disease. They help normalize the function of all body systems, significantly improving the patient's overall condition.
There's no need for immunosuppressive therapy before intravenous stem cell transplantation, since all stem cells — regardless of whether they're autologous (the patient's own) or allogeneic (donor) — have immunomodulatory and immunosuppressive properties.
Stem cells are administered via a wide-bore IV drip. The doctor determines the number of cells and the frequency of injection sessions for each individual case. The procedure typically takes 40–45 minutes and is carried out under specialist supervision, with continuous monitoring of blood pressure, pulse, heart rate, breathing, temperature, and the patient's overall condition.
2. Intrathecal route of administration: stem cells are administered directly into the spinal canal. Carried by the flow of cerebrospinal fluid, they cross the blood-brain barrier and settle directly in nerve tissue at sites of brain and motor neuron damage. There, they stimulate central nervous system regeneration, slow disease progression, and in some cases restore lost function. Administering stem cells into the spinal canal slows the destruction of motor neurons and helps partially restore the structure of the spinal cord. By replacing dead neurons, stem cells reduce symptoms and improve motor impairments without triggering a negative immune response in the body.
3. Intranasal route — administering stem cells and exosomes (a concentrate of regenerative substances in the form of vesicles produced by stem cells) to the patient by inhalation. This allows stem cells and exosomes to reach the brain directly through the vascular network of the nasal passages. This method can be used to address the cognitive manifestations of a condition: it improves behavioral responses, speech, attention, mood, sleep, and social adaptation, and importantly, it's very well tolerated by patients.
4. Local route of administration — administering stem cells directly into the affected area (joints, muscles, skin, etc.). This is achieved through injection or via physiotherapy (electrophoresis).
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