Regenerative medicine approaches, such as replacement of damaged tissue by ex vivo manufactured constructions or stimulation of endogenous reparative and regenerative processes to treat different diseases, are actively developing. One of the major tools for regenerative medicine are stem and progenitor cells, including multipotent mesenchymal stem/stromal cells (MSC). Because the paracrine action of bioactive factors secreted by MSC is considered as a main mechanism underlying MSC regenerative effects, application of MSC extracellular secreted products could be a promising approach to stimulate tissue regeneration; it also has some advantages compared to the injection of the cells themselves. However, because of the complexity of composition and multiplicity of mechanisms of action distinguished the medicinal products based on bioactive factors secreted by human MSC from the most of pharmaceuticals, it is important to develop the approaches to their standardization and quality control. In the current study, based on the literature data and guidelines as well as on our own experimental results, we provided rationalization for nomenclature and methods of quality control for the complex of extracellular products secreted by human adipose-derived MSC on key indicators, such as “Identification”, “Specific activity” and “Biological safety”. Developed approaches were tested on the samples of conditioned media contained products secreted by MSC isolated from subcutaneous adipose tissue of 30 donors. This strategy for the standardization of innovative medicinal products and biomaterials based on the bioactive extracellular factors secreted by human MSC could be applicable for a wide range of bioactive complex products, produced using the different types of stem and progenitor cells.

Objective: Evaluation of the lag timelines for the launch of innovative drugs to the Russian market and pharmacoeconomic factors they can depend on. Methods: To complete the investigation, we used information about drug products, namely, dates of submission and approval, and pharmacological groups recovered from national registers and official databases. Results: Due to impacts of market factors and imperfection of the state regulation, original drugs developed abroad enter the Russian market a few years after their registration in the United States of America, the European Union, and Japan. The average time from the moment of initial approval of a drug in the aforementioned countries and jurisdictions to the moment of registration in Russia is 4 years and 8 months, with a median value of 2.5 years. It has been shown that half of this term is spent on the performance of the procedures of the expertise of the drug registration dossier in the Russian Federation. Conclusion: To attain the goal of adequate supplies to the population of the Russian Federation of the most up-to-date, high quality, safe, and efficacious medications, apart from the support of national originators of innovative drugs, we are required to upgrade the existing system of original drug registration. Improvement should be primary focused on the drugs already approved by the leading national regulatory authorities in order to ensure innovative medicine access for Russian patients.

The intensive development of cellular technologies stipulates the introduction at the global level of medicinal products based on viable human cells, which in most countries are referred to as biomedical cell products. The authors conducted a comparative analysis of the regulatory framework in different countries and determined special aspects of regulation of cell therapy products (analogues of biomedical cell products). Some countries have mechanisms for priority review of cell therapy products for marketing authorization, such as accelerated assessment, accelerated approval, or conditional marketing authorisation. These mechanisms are currently absent in Russia, because of the novelty of the regulatory framework, and the biological properties of innovative cell products. Biomedical cell products are regarded as a separate class of medicinal products in Russia, they are not treated as biologicals and are regulated by the Federal Law No. 180-FZ «On Biomedical Cell Products» of June 23, 2016. The main difference in regulation of cell-based products in the Russian Federation is the principle of unified requirements for marketing authorisation of autologous, allogeneic, and combined biomedical cellular products, and the absence of the «hospital exemptions» mechanism that exists in many countries. This mechanism allows prescription and use of personalised autologous medicines produced in the laboratory of a medical institution for a particular patient.

Tissue engineering has become a new promising strategy for repairing damaged organs of the urinary system, including the bladder. The basic idea of tissue engineering is to integrate cellular technology and advanced bio-compatible materials to replace or repair tissues and organs. of the study is the objective reflection of the current trends and advances in tissue engineering of the bladder using acellular matrix through a systematic search of preclinical and clinical studies of interest. Relevant studies, including those on methods of tissue engineering of urinary bladder, was retrieved from multiple databases, including Scopus, Web of Science, PubMed, Embase. The reference lists of the retrieved review articles were analyzed for the presence of the missing relevant publications. In addition, a manual search for registered clinical trials was conducted in clinicaltrials.gov. Following the above search strategy, a total of 77 eligible studies were selected for further analysis. Studies differed in the types of animal models, supporting structures, cells and growth factors. Among those, studies using cell-free matrix were selected for a more detailed analysis. Partial restoration of urothelium layer was observed in most studies where acellular grafts were used for cystoplasty, but no the growth of the muscle layer was observed. This is the main reason why cellular structures are more commonly used in clinical practice.