The Russian government has introduced a temporary permitting procedure for the import into the Russian Federation of biomedical cell products (BMCP). The relevant decree of the Government of the Russian Federation of 16.10.2018 No. 1229 was signed by Prime Minister Dmitry Medvedev. Permission for temporary admission will be valid from November 1, 2018 to April 30, 2019 and will apply to the following BMCP [3]:

1. “Audencel”
2. “Eltrapuldencel”
3. “Spanlecortemlocel”

These BMCP are planned to be delivered for the purpose of conducting preclinical, clinical and registration procedures, as well as for specific patients in need. The right to import unregistered BMCP will have:

– Manufacturer and copyright holder

– Universities and scientific institutions

– Medical institutions.

In order to import the abovementioned BMCP into the territory of the Russian Federation, an import permit from the Ministry of Health will be required. Decree No. 1229 also regulates the documents that must be submitted to the Ministry of Health to receive it.

Briefly about pioneering products:

1. Audencel is BMCP, which is an autologous dendritic cell secreting interleukin-12 loaded with a lysate of an autologous tumor. Audenzel was developed by a group of scientists from Activartis Biotech GmbH . It is planned to be used for the treatment of patients with oncological diseases. However, it is worth noting that clinical studies that ended recently in Europe showed that this drug is not effective in treating glioblastoma [1]. Information on other indications for use could not be found.
2. “Eltrapuldencel” is BMCP, representing autologous dendritic cells loaded with antigens from self-sustaining, proliferating autologous irradiated tumor cells in a solution of granulocyte-macrophage colony-stimulating factor. This product is also planned to be used in the framework of immunotherapy of oncological diseases. The developer of this product is Caladrius Biosciences, Inc., a US company. In the open access, there is evidence of a clinical study in which patients with melanoma showed significant improvements in the use of this drug. [2]
3. “Spanlecortemlocel” consists of CD34 hematopoietic stem cells isolated from umbilical cord blood and cultured in vitro in medium supplemented with thrombopoietin, stem cell growth factor, interleukin-6, ligand of fms-like tyrosine kinase 3, an aromatic receptor antagonist The product was developed by Novartis and is intended for the treatment of acute lymphoblastic leukemia.

 References:

1. Buchroithner, J.; Erhart, F.; Pichler, J.; Widhalm, G.; Preusser, M.; Stockhammer, G.; Nowosielski, M.; Iglseder, S.; Freyschlag, C.F.; Oberndorfer, S.; Bordihn, K.; von Campe, G.; Hoffermann, M.; Ruckser, R.; Rössler, K.; Spiegl-Kreinecker, S.; Fischer, M.B.; Czech, T.; Visus, C.; Krumpl, G.; Felzmann, T.; Marosi, C. Audencel Immunotherapy Based on Dendritic Cells Has No Effect on Overall and Progression-Free Survival in Newly Diagnosed Glioblastoma: A Phase II Randomized Trial. Cancers 2018, 10, 372. – .pdf
2. Asad Javed, Shingo Sato, and Takami Sato. Autologous melanoma cell vaccine using monocyte-derived dendritic cells (NBS20/eltrapuldencel-T) Future Oncology 2016 12:6, 751-762
3. http://www.roszdravnadzor.ru/spec/biomedical/news/14347
4. https://vademec.ru/news/2018/08/20/minzdrav-vremenno-razreshit-vvoz-nezaregistrirovannykh-biomeditsinskikh-kletochnykh-produktov/