Standard medical care

Contemporary medical specialized and highly technological healthcare is regulated by the standardized clinical protocols, methodical guidelines, instructions and recommendations approved by the national regulatory authority. In Russia this is the function of the Ministry of Healthcare of the Russian Federation, and the control is performed by the Roszdravnadzor and the Rospotrebnadzor. Medical care can be provided only by a healthcare organization. The term “Healthcare organization” is used in the meaning specified by the Federal law dated 21.11.2011 №323-FZ “On fundamental healthcare principles in the Russian Federation” (hereinafter the law №323-FZ). The healthcare services are provided on the basis of the license issued by the authorized public organization. The list of the activities of the Hospital is specified in the licenses for medical activities. According to the law №323-FZ, medical care is organized and provided according to the order of healthcare delivery that is mandatory for all healthcare organizations on the territory of the Russian Federation on the basis of the healthcare standards as well as with the consideration given to the standards of the healthcare including the healthcare services provided within the framework of clinical testing.

Neurovita Work The program of the state guarantees to deliver free medical care to the citizens of the Russian Federation are formed with the consideration of the order of healthcare delivery and on the basis of the healthcare standards as well as with reference to the characteristics of the age and gender composition of the population, the level and structure of the disease incidence of the population of the Russian Federation based on the medical statistics data. The provided services are covered from the Federal Compulsory Medical Insurance Fund (FFOMS) according to the insurance certificate of the Russian resident. The healthcare organization that provides commercial medical care to the population is obliged to provide the information about the opportunity to receive the appropriate types and scopes of medical care free of charge within the framework of the program of the state guarantees to deliver free medical care to the citizens of the Russian Federation and the territorial program of the state guarantees to deliver free medical care to the citizens of the Russian Federation.

Neurovita Work The medical standard is defined as a minimal mandatory volume of medical care that must be provided to any resident of the country in the case of the specific nosology (type) of the disease. In Moscow and Russian regions these standards vary, but generally they provide high level of diagnostics and therapy. The treatment of Russian patients and foreign residents can be commercial and is regulated by the appropriate regional standard of the medical care; it can be covered by the patient, or by the Voluntary Health Insurance Fund (FDMS) through insurance companies where an individual can be insured on their own or by the employer. The specialists of our Hospital are experienced in providing commercial medical care services to the patients forwarded by the system of the FDMS according to Moscow standards of the healthcare delivery to the population approved by the Healthcare Department of Moscow.

Innovative medical care

The development of new medical standards of diagnostics and therapy of various diseases, injuries and their consequences is a long and complicated path as almost all innovations in medicine have to cover a long way from fundamental research, preclinical cultural and animal trials to long-term multicenter clinical trials. The path from bench to bed is long and winding. On the one hand, it is associated with the conservativeness of medicine as it is, and, on the other side, with potential risks and negative consequences for human health. All stages of introduction of the innovations into medical standards require massive investments at every stage. So, the period of introduction of every new method of diagnostics and treatment into practice may take years, and, sometimes, decades, especially at the stage of their clinical testing. Neurovita Work

However, sometimes in emergency case the regulator of the national healthcare system takes the decision to promote the innovation to the standard in a fast-track procedure. A good example of it is the urgent approval of the coronaviral vaccines in 2020 in different countries of the world. The evidence about a real effect and safety of any innovative method, as well as long-term effects on a human health will be gathered only with the time. The history of innovations promotion especially in pharmacology knows a lot of delusions and even tragedies, especially when the treatment methods were physician-induced or had remote side-effects, such as tumors, autoimmune processes, various tissue degenerations and others.

But development of a new is impossible without a scientifically grounded risk both on the side of the researcher and on the side of the researched. The methods might demonstrate miraculous effectiveness in rats and mice, but might fail in humans.

For over two decades our interests have belonged to the development of the novel methods of treatment of the consequences of severe brain and spinal cord injury using autologous (patient’s own) and allogeneic (donor’s) hematopoietic personalised therapys (cells).

The clinical testing of these technologies in almost 7 000 cases of severe traumatic injury of the brain and spinal cord and over 25000 intrathecal and intraventricular (into the cerebrospinal fluid) administrations as well as intramedullar (into spinal cord) transplantations of the cells humans have convincingly demonstrated their safety and efficiency: 60.4% of recovery of the damaged function.

Neurovita Work In 2005 and 2006 these technologies were approved by the Roszdravnadzor and received official status of the innovative biomedical technology approved for clinical application. Further, we started applying this technology to treat the consequences of the ischemic and hemorrhagic strokes, the neurodegenerative diseases, dementia, atrophic processes in the brain, consequences of neuroinfection and chronic vegetative states. The effectiveness of the restoration of the disordered functions in these types of patients varied from 37% to 65%. We treated the patients who had been rejected from the conventional treatment by contemporary medical care standards, and only palliative care at home or in hospice had been recommended to them. Our experience demonstrates that innovative neurorestorative treatment is able to improve the life quality of these patients and to extend their life span by the years in some cases. The key characteristics of the innovative therapy in the area of regenerative and postgenomic is that it is effective only in the case when the pathological process in the nervous tissue has been arrested, and no less than two to three months have passed since acute injury, hemorrhage, necrosis or ischemia. The therapy has no sense in the case of acute ischemic, inflammatory or hemorrhagic processes in the brain/spinal cord, as all transplanted cells forward to the focus of pathology due to the homing mechanism and are eliminated there because of the inflammation and enema in the neural tissue.

Twenty years of the clinical testing and dynamic follow up of over 12000 patients who received the cells transfusions showed no onset of cells associated cancers or any other adverse complications for 10 and more years of follow up. The explanation of it lies in the fact that we use only autologous or closely related adult cells that have already acquired the differentiation vector (direction for the development to become certain type of tissue) in the body of the donor or patient. Analyzing our 20-year experience of using novel technologies of the therapy we can officially claim that the transfusion of heathy cells is able to prevent cancer and can be a unique agent to treat it.

Thank to this evidence, our team of oncologists developed and patented an innovative technology of the precision personalised oncoimmunological treatment and prevention of cancer and other malignancies in adults. By now NeuroVita hospital has developed over ten biomedical technologies that have no parallels; they are protected by 20 patents of the Russian Federation and one patent of the USA. Over 210 original scientific works have been published and 20 academic monographs, both in Russian and in English. We developed a unique postgenomic technology of an ultra-early diagnostics of cancer and several neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease, Binswanger disease, senile and vascular dementia, amyotrophic lateral sclerosis and other. The technology of ultra-early postgenomic diagnostics of cancer and neurodegenerative diseases was nominated for the Healthcare Department of Moscow Government Award in 2020. The innovative remote controlled contactless method of restoration of the brain and spinal cord that was named radioneurobioengineering of the brain is included into the Rospatent list of 100 best inventions of Russia in 2017.

Our research has acquired a new round of the innovative development thanks to the cooperation with the team of Novosibirsk scientists headed Bogachev SS, the doctor of biological science, and Mikhail A. Shurdov, PhD, the Research Institute of Cytology and Genetic of the Russian Academy of Science. Twenty years of their research of cancer genetics led to the development of a new methodological approach that integrates the methods of tissue engineering and bioengineering of Moscow research team with the genetic works and approaches to the gene therapy of Novosibirsk scientists resulting in new solutions to the previously unapproachable challenges of neurology and oncology. We do hope that these innovations become new standards of the treatment for a whole range of lethal oncological and neurological diseases of civilization in the coming years.

Personalized medical care

The personalized medical care or medicine is the greatest advance and the main direction of the scientific development for contemporary healthcare of the world in the 21^st century. Personalized medical care aims at the individually tailored therapy of extremely severe patients with various types of malignant diseases as well as at the individual therapy of the hereditary diseases of nervous system and organic diseases of the central nervous system (CNS).

The main principle of the personalized approach to the treatment in a specific case is based on the analysis of the patient’s molecular-biological (genomic, transcriptomic, proteomic, metabolomic and secretomic) data and development of an individual personalised and/or gene-therapeutic preparation that affects specifically the detected pathogenetic molecular markers in a certain case.

Neurovita Work To date the opportunity to employ the personalized approach to the treatment of intractable and rare diseases is regulated by the Order of the Ministry of Healthcare of the Russian Federation №186, dated April 24, 2018 “On Validation of the Concept of Predictive, Preventive and Personalized Medicine”. According to the recommendations of the Order of the Minister of Healthcare of the Russian Federation, our Hospital defines its priority directions for the personalized, preventive and predictive medical care: oncology, neurology, autoimmune diseases, rare hereditary diseases of nervous system, as well as the issues of longevity and increase of average lifespan of a human. The choice of these directions is conditioned by our long-term research, the results of which are protected by the patents of invention (30 patents of the Russian Federation and one USA patent). The following competences have been defined as having top priority:

The development of the scientifically grounded methodical recommendations on using the immunotherapy technology of predictive, preventive and personalized medical care in neurology, oncology and geriatrics;
The isolation of the neurological/oncological patient’s biomaterial, the analysis and processing of the molecular-biological (genetic, proteomic, transcriptomic, metabolomic) data using neural networks and artificial intelligence;
The use of genomic and post-genomic biomarkers to monitor the effectiveness of the diagnostics and treatment of the non-infectious nervous and oncological diseases of civilization;
The development, preclinical and clinical trials and registration of the non-manipulated and low-manipulated cell preparations, biomedical cell products (BMCPs) and gene-therapeutic preparations for the personalized regenerative and post-genomic medical care for neurological and oncological patients;
The development and use of the DNA-restored hematopoietic personalised therapy and progenitor cells for the therapy of some of the incurable hereditary, oncological, autoimmune, neurodegenerative and rare diseases of the nervous system;
The development, registration and use of the autologous cell vaccines loaded with virus-specific or pathology-specific protein antigens in the neurooncological cases;
The virus-lytic therapy for the personalized treatment of lethal oncological and neurological diseases;
Development of the standards of efficiency and safety of application of the cell preparations and BMCPs in neurology oncology and geriatrics.

Neurovita Work The personalized molecular-biological diagnostics relies on the complete or partial genome sequencing, transcriptome and proteome mapping and profiling of the cell system, as well as development of individually tailored molecularly targeted personalised and/or gene-therapeutic preparations and BMCPs. This conceptually new scientific, methodological and biotechnological platform of the personalized diagnostics and treatment permitted development of the precision recombinant DNA therapy of the hereditary diseases of nervous system. It takes two to six months, or, sometimes a year, of painstaking work of a large team of immunologists, geneticists and molecular biologists to develop the personalized cell preparation for a specific patient after the main genetic and proteomic markers of his/her pathological process and additional somatic mutations in his cells genome have been detected. Moreover, we are not able to restore the damaged cells of the patient in a 100%. We do not use the technologies of gene editing in our personalized medicines, cell preparations and BMCPs; we employ a nature-like mechanism of sanogenesis (natural instrument of self-restoration of the cells) of frequently dividing cells, which is known as homologous recombination (equal replacement) of the parts of DNA mutations and DNA and RNA of a healthy donor. In our case an autologous (patient’s own) cells independently uses the biomaterial that it is able to “take” from the provided genetic resource represented by the DNA of other tissues of the same organism or by the approved for clinical application therapeutic agent that contains the DNA of a healthy donor.

Neurovita Work The main achievement of our molecular biologists is the opportunity of the biomanagement of the recombination in the autologous cells and installation of the ideal conditions, under which this mechanism is able to activate in the cells of a specific patient. Our task is to verify the quality of the performed self-reconstruction of these personalised therapys, absence of neoplastic transformations and additional mutations that can induce genome instability. Expansion of healthy cells of the patient and re-infusion of them to the immunosuppressed patient helps overcome pathological clones of blood circulation and development of lethal complications.