Regenerative infusion biotherapy

Theory and Practice

The treatment of severe diseases is a demanding and labor-intensive process that becomes effective only when the sequence of therapeutic interventions is followed — interventions carried out with the utmost involvement of a team of specialists and with compliance (adherence to therapy) on the part of the patient's family.

The treatment of a number of autoimmune, including neurodegenerative, diseases proceeds in three sequential stages: antigen reduction, detoxification, and generation, all of which are carried out against the background of basic anti-inflammatory, mitochondrial, and hormonal therapy.

An important component of the rehabilitation-regeneration stage is the methodology of Infusion Regenerative Biotherapy.

Infusion Regenerative Biotherapy is a pluripotent cell that "can become" any cell of the human body.

Undifferentiated (i.e., "undecided") infusion regenerative biotherapy is the progenitor of all the body's cells, one that "chooses" its path based on the body's current needs. The principal properties of Infusion Regenerative Biotherapy are the ability to differentiate toward any cell and to further self-maintain.

Infusion Regenerative Biotherapy cells are extremely active; they continuously and rapidly divide, change, transforming into cells of various types and replacing old cells. It is worth noting that the division of Infusion Regenerative Biotherapy leads to the formation of new Infusion Regenerative Biotherapy, which results in a cumulative potential.

The uniqueness of the functionality of Infusion Regenerative Biotherapy lies in its differentiating potential, that is, the ability to replenish the functional capacity of the patient's body. Thus, in autoimmune, neurodegenerative, and neuroinflammatory conditions, upon receiving a neuronal signal about damage to one part of the body or another, the brain directs the externally supplied portion of Infusion Regenerative Biotherapy to the "focus of the lesion," where it transforms into the cells of the tissue and organ, replacing the damaged and non-functional ones. Infusion Regenerative Biotherapy is not the "entry" point for treating severe diseases, because the priorities of the physician and the patient (development, speech, skills, halting regression, halting organ degeneration, etc.) do not always coincide with the priorities of the body as a whole.

Roughly speaking, what is fundamentally important to us as a team is not necessarily fundamental and vitally necessary to the body from the standpoint of survival. Thus, a body in a systemic inflammatory process will never expend the Infusion Regenerative Biotherapy it has received on neuronal regulation, since this does not determine the body's survival.

A "prepared" body — one that has passed through antigen reduction and the detoxification stage — perceives Infusion Regenerative Biotherapy precisely on the basis of its diseased state, and therefore the treatment process becomes targeted (i.e., directed at a goal) and controllable.

The administration of Infusion Regenerative Biotherapy is a controlled and safe process thanks to its low immunogenicity — that is, its ability to provoke an immune response from the body — even in weakened and immunologically compromised patients.

Thus, infusion regenerative biotherapy opens up new possibilities in the rehabilitation and treatment of severe diseases owing not only to its ability to differentiate into the "needed cells" (pancreatic cells in diabetes or neurons in neurodegeneration), but also thanks to its powerful immunomodulatory and paracrine effect.

The rehabilitative and safe transplantation procedure of Infusion Regenerative Biotherapy should not be confused with a bone marrow transplant.

A bone marrow transplant is a method used in hematology-oncology. It is a rather dangerous and difficult method that follows sequentially after chemotherapy and is associated with a number of complications.

A bone marrow transplant involves harvesting Infusion Regenerative Biotherapy from a donor's bone marrow and transplanting it after the patient's own bone marrow has been destroyed by chemotherapy.

Rehabilitative transplantation of Infusion Regenerative Biotherapy is a method that provides not for the suppression, but for the modulation of the patient's immune response and the stimulation of regenerative processes.

Cell Sources

Depending on the source of the cells, cell products can be divided into the following groups:

1. Autologous products (obtained from the patient's own cells). Autologous cells have the greatest chances of functioning in the patient's body, since they are not rejected by their immune system. However, in many diseases the use of one's own cells is impossible due to their functional defect (hereditary diseases), their scarcity and/or the impossibility of extracting them from the patient's body (diseases of the liver, of the nervous system), or contamination with tumor cells.
2. Allogeneic products (cells of a human donor). Despite the absence of a complete match between recipient and donor, the procedure of transplanting donor cells is safe thanks to the low immunogenicity of Infusion Regenerative Biotherapy. This is determined by the characteristically extremely low degree of expression of the antigen-presenting molecules MHC class I and II.
3. Xenogeneic products (animal cells). Despite occasional reports of the effectiveness of such treatment methods in oncological, autoimmune, and chronic diseases, systematic scientific analysis has not confirmed the presence of an objective improvement in patients' condition with their use.

Owing to the frequency of mitochondrial dysfunction, the presence of a number of genetic polymorphisms, and pronounced dysfunction of the immune system, the principal method in our practice is the transplantation of allogeneic Infusion Regenerative Biotherapy (i.e., cells obtained from a healthy donor).

Mechanisms of Action of Infusion Regenerative Biotherapy

Infusion Regenerative Biotherapy contributes to the restoration of homeostasis — the constancy of the internal environment — and becomes involved in the process of regeneration, repair, and adaptation of the mesenchymal cell system.

Of particular significance is the ability of Infusion Regenerative Biotherapy (directly and indirectly) to interact with the cells of the immune system, primarily by means of soluble factors and cell-contact interaction. This effect makes it possible to considerably modulate the body's immune response, suppressing the proliferation of CD4+ T cells, CD8+ T cells, B cells, and NK cells, as well as inducing the proliferation of regulatory T cells, while simultaneously shifting the secretory "profile" toward anti-inflammatory cytokines (promoting the induction of type 1 dendritic cells to reduce the secretion of TNF-α and of type 2 dendritic cells to increase the secretion of IL-10).

One of the fundamental mechanisms of action of Infusion Regenerative Biotherapy is its paracrine effect. The term "paracrine" in our discussion denotes a process in which Infusion Regenerative Biotherapy acts not only directly, replenishing the defect, but also by producing special substances — factors that act as signaling molecules for the surrounding cells, causing them to alter their biochemical processes and leading to the initiation of regeneration.

Infusion Regenerative Biotherapy in the Treatment of Autism

In particular, cell therapy holds enormous potential in the treatment of autism. Underlying the development of autism spectrum disorders, systemic inflammatory and autoimmune processes, dysfunction of innate and adaptive immunity, as well as disruption of the functional activity and plasticity of synaptic connections, are of significant importance.

Infusion Regenerative Biotherapy plays a role in the mechanisms of synaptic modulation and function through:

• modulation of neuronal plasticity by means of the secretion of specific growth factors,
• which support synaptic plasticity, the release of regenerating synaptic mediators, and the integration of the incorporation of neurons into existing synaptic networks.

In addition to their powerful anti-inflammatory action, Infusion Regenerative Biotherapy exerts an influence through the inhibition of dendritic cell maturation, by means of:

• suppression of pro-inflammatory activity, control over the generation of regulatory T cells,
• polarization of macrophages toward an anti-inflammatory state,
• reduction of the proliferation and activation of B cells,
• suppression of the proliferation and cytotoxicity of NK cells
• remodeling or improving the functioning of tissue (improving the vascularization of an ischemic focus, stimulating the regeneration of donor tissues in diseases of the liver or nervous system, etc.);

The procedure of preparation for Infusion Regenerative Biotherapy, its administration, and observation in the post-transplantation period

Infusion Regenerative Biotherapy is a fairly lengthy process owing to the thorough preparation required. Preparation for Infusion Regenerative Biotherapy transplantation is the first stage of therapy, comprising:

• antigen reduction (oral or infusion-based, depending on the clinical situation);
• detoxification infusion therapy or prolonged oral therapy, provided the liver's detoxification systems are intact, often including the use of Membrane Cascade Plasmafiltration and subsequent replacement immunoglobulin therapy;
• comprehensive mitochondrial therapy (oral, which the patient begins on an outpatient basis, and instrumental, in the form of the REMIT mitochondrial support complex);
• membrane-stabilizing infusion therapy;
• combined hormonal support with restoration of the hypothalamic-pituitary-adrenal axis.

The greater part of the preparatory work for Infusion Regenerative Biotherapy is carried out in the format of outpatient work with a physician. The rehabilitation block of mitochondrial, hormonal, and transplantation work can be performed in parallel (this requires separate discussion with the attending physician).

The Transplantation Procedure

In our clinical practice, Infusion Regenerative Biotherapy is the third, rehabilitative stage of therapy, and therefore one cannot "begin" with the cells. The procedure is prescribed exclusively by the attending physician at the moment when the body is ready. This is necessary in order to achieve the maximum effectiveness of the procedure.

After completing the outpatient preparation, a process of preparation for the transplantation is required, which may include instrumental mitochondrial preparation (REMIT) and infusion therapy, or may not include them, depending on the clinical situation.

The patient's preparation and rehabilitation map is developed individually; however, there are basic rules:

1. The transplantation is prescribed by the clinic's attending physician strictly after the preparatory stages have been carried out;
2. Infusion Regenerative Biotherapy should be postponed if any signs of an acute respiratory viral infection or a cold arise (cough, runny nose, nasal congestion, elevated body temperature, nausea and vomiting, acute stool disorders, etc.);
3. The decision on whether the transplantation should be postponed, when to conduct repeat examinations, and setting the dates of the procedures is agreed upon with the attending physician;
4. The dates of the preparatory manipulations and of the transplantation itself are discussed in advance (at least 2 months before the procedure);
5. Before the transplantation it is necessary to undergo additional examinations that rule out acute inflammatory and neuroinflammatory processes, metabolic disorders, immunological tests, and other examinations agreed upon with the attending physician (an approximate list of examinations is provided below);
6. On the appointed date and time, at least 1–2 days before the procedure, a pre-transplantation consultation is held between the attending physician and the clinic's leading specialists;
7. If there are indications, intensive detoxifying, anti-inflammatory therapy and correction of mitochondrial disorders are carried out; the intensity is achieved through the intravenous route of administration and the use of extracorporeal techniques, including Membrane Cascade Plasmafiltration;
8. For the transplantation, a peripheral catheter is placed in the patient;
9. Against the background of the recommended (see item 5) or nonspecific detoxifying metabolic therapy and vitamin therapy, on the 2nd–3rd day the transplantation is carried out;
10. The administration of Infusion Regenerative Biotherapy (2–2.5 billion cells) is performed slowly intravenously over the course of 30 minutes under the supervision of the on-duty physician and nursing staff;
11. The subsequent 1–3 days after the transplantation are conducted under observation; in parallel, hormonal support is provided to enhance the paracrine effects;
12. Discharge follows a concluding consultation or a consultation with the attending physician, with the determination of a road map for further post-transplantation observation (usually, during the first month after the transplantation, follow-up meetings with the physician (in person or remotely) are held once every 10–14 days, and thereafter once a month.
13. During the post-transplantation period, one should maintain a protective regimen, avoid immunological provocation, and adhere to the recommended diet and the schedule of medications prescribed by the attending physician;
14. If necessary, a repeat procedure is possible no earlier than 3 months after the first transplantation.

The Set of Laboratory Examinations in the Pre-transplantation Period:

(The list may change depending on the specific clinical situation at the discretion of the attending physician):

1. Complete blood count with leukocyte differential and ESR;
2. Biochemical blood test;
3. Coagulogram;
4. S100 protein
5. Neuron-specific enolase
6. TNF-alpha
7. Interleukin-1β, 6, 8
8. Rheumatoid factor
9. C-reactive protein
10. Antistreptolysin-O
11. Eosinophil cationic protein, IgE
12. Urine organic acids, 60 indicators;

Additionally, the following may be required:

• Blood amino acid composition;
• Urine amino acid composition;
• Acylcarnitine profile;
• ANF (antinuclear factor)
• ANA immunoblot;
• Neurotest;
• Steroid hormones, steroidogenesis;
• Immunogram;
• Blood and saliva test for herpes viruses (1, 2, 6, CMV, EBV).
• Test for Parvovirus B19.
• Oropharyngeal and nasopharyngeal swab for PCR for respiratory infection viruses.
• Bacterial culture of an oropharyngeal swab.
• Analysis of the state of the small intestine microflora by chromatography-mass spectrometry.
• Culture for Candida of material from the oropharynx and from saliva.
• Analysis of the state of the small intestine microflora by chromatography-mass spectrometry.
• Specific antibodies to the main species of helminths.
• Detection of helminths (various forms) in stool.