Development of the Combined Hemosorbent for Optimization of Treatment and Prophylaxis of Septic Pathology Caused by Gram-Negative Flora
Tech Area / Field
- CHE-SYN/Basic and Synthetic Chemistry/Chemistry
3 Approved without Funding
Belarusian State Medical University, Belarus, Minsk
- Institute of Bioorganic Chemistry, Belarus, Minsk
- University of Brighton / School of Pharmacy and Biomolecular Siences, UK, Brighton\nTrillium Diagnostics, LLC, USA, ME, Brewer
Project summaryThe Project aim. to create new object of medical technology - the combined hemosorbent for the purpose of efficiently decrease of endotoxin for increase survivability of patients with septic diseases caused gram-negative flora, to lead clinical trials developed sorbent.
Current status. The analysis of a problem point at:
- common sickness rate of the septic pathology is high all over the world and has no tendency to decrease;
- more than half of cases of purulent infections it is caused by gram-negative flora. It is characterized by fast generalization of disease with development of multiple organ failure in 48-90 % (Dellinger R. P., et. al., Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock: 2008, 2008);
- the most perspective methods of the gram-negative sepsis treatment it is considered biospecific hemosorption (Yaroustovsky M.B. et. al., Lipopolysaccharide adsorption in combined therapy of patient with severe sepsis., 2008).
- working out the new, highly effective and affordable sorbent for endotoxin elimination is the actual social problem that will allow to raise survival rate of considerable group of patients.
In that way, this project is important today and very perspective.
The project’ influence on progress in this area.
- application of the combined hemosorbent will allow to optimize methods of treatment and prophylaxis of septic diseases that will allow to increase survival rate of patients greatly;
- using the given sorbent in medical practice led to considerable reduction of hospitalization period for patients with septic pathology;
- the developed methods of treatment and prophylaxis of septic pathology with application of the combined sorbent will allow to save money which can be apply to treatment other patients.
The participants’ expertise. Research workers in laboratory hemo-and lymphosorption in BSMU, have a wide experience in application efferent methods in treatment of various diseases, during many years successfully working out and introducing in medical practice new sorbents, that are patented in Byelorussia (more than 15), publications and performances at the international conferences is available on Internet site “http://www.bsmu.by”. The laboratory of applied biochemistry in the National Academy of Sciences of Belarus, taking part in the project, together with laboratory hemo-and lymphosorption in BSMU, syntheses new hemosorbents successfully. Employees of the given laboratory were patented 7 hemosorbents. Altogether in the project take part 1 Doctor of Medicine, 1 Doctor of Biology Science, 1 candidate of medicine with experience in area efferent medicine. 2 candidates of technical sciences with experience in working out weapons. Experts in chemistry and biology from BSMU and IBOCH have experience in the field of immunology and microbiology, biochemistry and chemical synthesis, including area of creation of the weapon of mass destruction.
Expected results and their application. during realization 5 tasks of the project will take following results:
- technology of synthesis and a pre-production model of the mass-transfer arrangement for the original combined hemosorbent;
- estimation of hemocompatibility and sorption capacities of the combined hemosorbent in vitro;
- estimation of specific efficiency of the hemosorbent on biological models; the project of specifications on a hemosorbent; certificates of sanitary, hygienic and toxicological tests; the program of clinical trials;
- reports of carrying out clinical trials; methods of treatment of pathology with application of the combined hemosorbent;
- long-term statistical forecasts by efficiency of the developed hemosorbent.
As a result, the new combined hemosorbent for elimination bacterial endotoxin and toxic metabolites from blood will be created, clinical trials of the developed sorbent which will confirm its efficiency. The results will allow increase of efficiency of treatment and decrease in death rate of patients with septic diseases.
The scientific importance of the project - new knowledge in pathogenesis and treatment of septic pathology that will allow formulating new and correcting already available hypotheses of sepsis development.
The practical importance of the project assumes introduction of the combined hemosorbent in medical practice in the countries of near and far abroad. Comprehensible cost of a sorbent will allow using widely it in clinical practice of developing countries.
The commercial importance of the project will allow presenting the combined hemosorbent and the developed technology of synthesis of a hemosorbent for sale on the foreign markets in long-term prospect.
The fields of application the results of the project:
- Biochemistry and biotechnology, technology of synthesis and an estimation of efficiency of hemosorbents;
- Clinical medicine (efferent therapy), recommendations for treatment and prophylaxis of septic pathology;
- Experimental medicine, working out and introduction of experimental models for research of hemosorbents.
Meeting the ISTC goals and objectives. The project corresponds to the ISTC goals and objectives:
- reorients the participants of the project connected with working out of weapon technologies on peace activity in the medical purposes by application of their knowledge for creation the combined hemosorbent;
- promotes integration of weapon participants into world scientific community by participation in the decision of actual problems on decrease in death rate of the population;
- supports transition to market economy by creation commercial product, that give possibility in the future to pass to self-financing by the organization of production developed sorbent and place to the foreign and domestic markets;
- supports applied researches - developments and demonstrations technologies in the peace purposes in the field of public health and medicine;
- promotes the decision of national and international problems of the health care by decrease of death rate from septic diseases.
Scope of activities. Project Duration - 30 months; total project effort – 2775 person*days; total project effort of weapon scientists - 1670 person*days. Participants: BSMU - to estimate efficiency of the experimental hemosorbent, work out the treatment schemes of patients with septic pathology, select and treatment patients with septic pathology with application of efferent methods. Experts - chemists BSMU and IBOCH - work out technology of synthesis and application of the experimental hemosorbent, work out and creation the mass-transfer module, chemical synthesis of a hemosorbent, production of experimental samples of hemosorbent. All 5 problems of the project will be carried out sequentially.
Role of Foreign Collaborators/Partners. Group of scientists from USA, Great Britain and Germany expressed their wish to become Collaborators of this Project. Instrument for cooperation:
- Exchange of information during project implementation.
- Review of technical reports.
- Joint seminars, workshops, meetings, consultations.
- Joint publication and other type of project activities public presentation.
Technical approach and methodology. For goal achievement will be used modern methods of chemical synthesis of medical objects. Authors of the project have developed an original technique for estimation of the hemosorbents hemocompatibility with using modern biochemical and immunologic methods. There is beginning in selection the optimum matrix and effective ligands for working out of the combined sorbent. It had positive preliminary results which testify to high efficiency of ligands concerning pathogenic components in septic pathology. It is developed biological systems which model physiological processes for an estimation of hemosorbents efficiency. Clinical trials of the combined hemosorbent will be lead according to the program of clinical trials and the Helsinki Declaration, the international ethical and scientific quality standards of planning and carrying out of researches at the person, and also documentary registration and granting of results. Moreover is planned to organize production of the combined hemosorbent and its representation in the market.
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