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Russian scientists have made a very significant contribution to the science of stem cells and the development of cellular technologies in general. Indeed, in 1908 Professor of the Imperial Military Medical Academy in St. Petersburg, Alexander Maximov was the first to introduce the term “stem cell” in modern science and established the so-called unitary theory of hematopoiesis. According to the latter, all blood cells originate from a hematopoietic stem cell.
Currently in Russia a number of specialized research institutes, medical centers and biotech companies are keeping pace with the world of science in the development and introduction of cell and gene technologies into clinical practice. Under the guidance of world-renowned scientist Paolo Macchiarini (Karolinska Institutet (Sweden) several artificial trachea transplants grown from stem cells were successfully completed in Russia. Also, the industry of cells and tissues banking, especially the banking of hematopoietic stem cells of umbilical cord blood is being successfully developed in Russia.
Development of the biotech industry in Russian Federation requires the harmonious development of the relevant regulatory base. So, the application of new cellular technologies in health care should be carried out in accordance with:
- Federal Law of 08.08.2001 “On Licensing Of Certain Types Of Activities”;
- RF Government Decree of 04.07.2002 “On Approval Of The Regulation On Licensing Of Medical Activity” and “On Approval Of The Federal Service On Surveillance in Healthcare” of 30.06.2004;
- Order of the Russian Ministry of Health № 238 “On The Organization Of Licensing Medical Activities” of 26.07.2002;
- approved temporary license requirements and conditions for the application of new cellular technologies in health care.
Thus, the practical application of cell technologies in health care is possible only after they are fully approved as well as the appropriate techniques and licensing requirements and conditions to the performance of these techniques.
Instruction of the Ministry of Health of the Russian Federation of 18.04.2002 “On The Procedure Of Research In The Field Of Stem Cell Technologies And Their Use In Health Care” establishes uniform requirements to obtaining and application of human stem cells for therapeutic purposes. Collection, preparation and isolation of stem cells should be conducted in public health care facilities in compliance with the current legislation of the Russian Federation due to the permission of the Expert Council of the Ministry of Health of Russia and controlled by ethics committees.
The work with hematopoietic stem cells is regulated by the following regulations of the Russian Ministry of Health:
- Order on issuing permits for the application of medical technologies (31.12.2004);
- Order of 25 July 2003 N 325 “On the development of cellular technologies in the Russian Federation”;
- Temporary instruction on the research in the field of cell technologies and their application in health care facilities (18.04.2002);
- The project “New cell technologies for the medicine”;
- Order of the Ministry of Health of 29.08.2001 № 345 “On the establishment of the Expert Council review of research in the development of stem cell technologies and their introduction into practical health care”;
- RF Law ” On the temporary ban of the cloning of human beings” (2001);
- Code of Medical Ethics (1997);
- Code of Ethics of the Russian doctor (1994);
- Ministry of Health Order N 301 of 28 December 1993 authorizing the practice of artificial fertilization;
- RF Law on Organ and (or) human tissues transplantation”(1992);
- State register of new medical technologies;
- Fundamentals of Russian legislation in health care;
- Directive of the Ministry of Health “On Invalidating documents on cell preparations” (06.03.2002).
Activity of a cord blood bank, as well as collection, processing, testing and storage of umbilical cord blood is carried out in accordance with the Order of the Ministry of Health of 25 July 2003 N 325 “On the development of cellular technologies in the Russian Federation.” This Order approves:
- Instruction on the collection of the umbilical cord / placental blood for research work.
- Instruction on isolation and storage of human umbilical / placental blood stem cells concentrate.
- The statement on the Bank of human umbilical / placental blood stem cells.
The bank of human umbilical / placental blood stem cells may be created due to the agreement with the Russian Ministry of Health on the basis of scientific or educational medical organization and is its structural subdivision.
To date, in the CIS countries the issue of legal regulation of export of cell and tissue preparations, preserved in national cryobanks for the treatment in foreign clinics requires improvement. The harmonization of legislation, regulating the activities of cryobanks and clinical trials due to the world experience will favor the providing of high quality and safe services of cryo-storage and clinical application of cell preparations to the citizens of CIS countries.