Minimally manipulated cells
Minimally manipulated cells are non-cultured (non-expanded) cells isolated from the biological material by its grinding, homogenization or selective collection of cells, which undergo minimal manipulation.[1] Minimally manipulated cells are usually using for the treatment of skin ulceration, alopecia, and arthritis.[2][3] Minimally manipulated cells can be used for the intraoperative creation of tissue-engineered grafts in situ.[4]
International regulation
[edit]Minimally manipulated cells are allowed to be an object of manufacture and homologous transplantation in USA and European Countries. The criteria of "minimal manipulation" are variative in different countries. European regulations, according to the Reflection Paper on the classification of advanced therapy medicinal products of the European Medicines Agency, define "minimal manipulation" as the procedure that does not change biological characteristics and functions of cells.[5] In particular, enzymatic digestion of biomaterial is prohibited, when cell-to-cell contacts are dissociated.[citation needed]
According to the US regulations (US 21 Code of Federal Regulations § 1271.3(f)(1), Section 361) human cells and tissues and tissue-based products (section 361 HCT/Ps), “minimal manipulation” is a processing that does not alter the original relevant characteristics of the structural tissue relating to the tissue’s utility for reconstruction, repair, or replacement.[6]
Russian regulations provide no specific definition for “minimally manipulated” cells. However, it follows from the content of the Order of Russian Ministry of Health No. 1158n “On amending the list of transplantation objects”. According to the Order, cells obtained from the biomaterial by its grinding, homogenization, enzymatic treatment, removal of unwanted components or by selective collection of cells, could be considered as “minimally manipulated”. Minimally manipulated cells are allowed to be an object of transplantation, when they do not contain any other substances except for water, crystalloids, sterilizing, storage, and (or) specific preserving agents.[7]
See also
[edit]References
[edit]- ^ Krasilnikova, Olga A.; Klabukov, Ilya D.; Baranovskii, Denis S.; Shegay, Peter V.; Kaprin, Andrey D. (May 2021). "The new legal framework for minimally manipulated cells expands the possibilities for cell therapy in Russia". Cytotherapy. 23 (8): 754–755. doi:10.1016/j.jcyt.2021.03.007. PMID 33985904. S2CID 234496221.
- ^ Ahn, Hyunjun; Lee, Sang Yeon; Jung, Won Ju; Lee, Kye-Ho (2021). "Alopecia treatment using minimally manipulated human umbilical cord-derived mesenchymal stem cells: Three case reports and review of literature". World Journal of Clinical Cases. 9 (15): 3741–3751. doi:10.12998/wjcc.v9.i15.3741. ISSN 2307-8960. PMC 8130094. PMID 34046478.
- ^ Di Matteo, B.; Vandenbulcke, F.; Vitale, N. D.; Iacono, F.; Ashmore, K.; Marcacci, M.; Kon, E. (2019). "Minimally Manipulated Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Systematic Review of Clinical Evidence". Stem Cells International. 2019: 1735242. doi:10.1155/2019/1735242. ISSN 1687-966X. PMC 6710724. PMID 31485234.
- ^ Krasilnikova, O.A.; Baranovskii, D.S.; Yakimova, A.O.; Arguchinskaya, N.; Kisel, A.; Sosin, D.; Sulina, Y.; Ivanov, S.A.; Shegay, P.V.; Kaprin, A.D.; Klabukov, I.D. (2022). "Intraoperative Creation of Tissue-Engineered Grafts with Minimally Manipulated Cells: New Concept of Bone Tissue Engineering In Situ". Bioengineering. 9 (11): 704. doi:10.3390/bioengineering9110704. ISSN 2306-5354. PMC 9687730. PMID 36421105.
- ^ Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004. Official Journal of the European Union. 2007; (L324): 121-131.
- ^ 21CFR1271.3 - Code of Federal Regulations. Title 21, Volume 8, Part 1271 -- Human Cells, Tissues, And Cellular And Tissue-based Products; 2020.
- ^ Russian Federation, Order of the Ministry of Health of the Russian Federation and Russian Academy of Sciences of October 27, 2020 No. 1158 “On amending the list of transplantation objects”; 2020. Available from: http://publication.pravo.gov.ru/Document/View/0001202012010034