One of the directions of work of State structures and commercial enterprises is development of technological platform and methodical recommendations on carrying out preclinical trials (PCT) for biomedical cell products.

Preclinical trials forbiomedical cell products are carried out on animals or in vitro by simulating pathological processes in which this product is planned to be applied.

Aims of preclinical trials:

– To identify the mechanism of product action

– To prove its safety and effectiveness.

PCT are carried out in accordance with the requirements of the following normative acts:

1. FZ № 180 “On Biomedical Cell Products” (art. 6, 11)
2. GOST 33044-2014 Principles of Good Laboratory practice
3. PCT guideline

Since 2016 the Order of the Ministry of Health of Russia “On approval of rules of good practice on work with Biomedical Cell Products” is at the stage of project. The first thing that catches the eye when reading this document is that it is not identical to the rules of Good Tissue Practice (GTP) of the USA and is not identical to the guideline for the industry “Preclinical Assessment of Investigational Cellular and Gene Therapy Products”  (USA). Perhaps one of the reasons for the differences is the different criteria for classifying products to BMCP.

It is important to note that according to this document “at registration of BMCP developed outside the Russian Federation in respect of which preclinical trials are carried out in the incomplete volume required by these rules, but there are reports on clinical trials, conducted in accordance with the regulatory requirements of the countries and the Federal law “On Biomedical Cell Products”, these results of clinical trials can be taken into account in the conduct of the state Registration to replace the missing preclinical research data. “

Thus, despite the different criteria for classifying products to BMCP, there is a chance that some documents from foreign registration dossiers can be appended to the registration in the Russian Federation.

The result of the PCT is the report on the preclinical trials and the permission to conduct clinical trials of BMCP.

In addition, according to the results of PCT manufacturer or developer BMCP makes a document called specification, which contains information about the type of BMCP, its qualitative and quantitative composition, biological and other characteristics of the cell line (cell lines) and BMCP.

The abovementioned documents are an essential part of the registration dossier.

As for the practical side of the issue, there is evidence that the Institute of Regenerative Medicine of the Lomonosov Moscow State University together with “Selltera Pharm”, LLC (presentation here – Селлтера ДКИ) developed methodologies, protocols and standard operating procedures (SOP) for carrying out PCT on animal models of diseases. The developed platform regulates: Isolation, allocation, purification, cultivation, typing, introduction to the body, assessment of activity and safety of BMCP.

Also, in the interaction of MSU and Selltera Pharm, LLC there have developed models of some diseases (arthritis, type 1 diabetes, etc.) for PCT.

References:

1. FZ № 180 “On Biomedical Cell Products”
2. Project of the Order of the Ministry of Health of Russia “On approval of rules of good practice on work with Biomedical Cell Products”
3. Меркулов В.А. Scientific expertise of BMCP – 2_-_Меркулов_В.А Научная экспертиза БМКП
4. http://irm.msu.ru/node/13