Probably a lot of people have heard about stem cells. There is a huge amount of reliable and unreliable information, as well as clinical studies about stem cells. However, few people know what stem cells actually are, what types of stem cells are; Where, how and for what can they apply?

1. Not every stem cell is used in medicine.

Stem cells are good primarily because they are able to develop into specialized cells, forming organs and tissues.

There are the following types of stem cells:

• Embryonic. Their application in clinical practice on the territory of the Russian Federation is forbidden, as their differentiation is difficult to control, and they can become sources of formation of teratom (tumors). In addition, the FZ 180 prohibits the use of embryonic stem cells for ethical reasons.
• Somatic (regional). These cells are found in all tissues and perform the function of a cellular reserve, which allows to replace damaged differentiated cells. Unlike embryonic stem cells, regional stem cells are able to develop into certain types of cells, but their differentiation is easier to manage, making them safer. This type of cells has several subtypes, one of which are mesenchymal stromal cells (MSC).

2. MSC (mesenchymal stromal cells)

As already mentioned in the article about the production of BMCP (more by the link), MSC are isolated from bone marrow, adipose and other vascularized tissues.

MSC have three unique properties that allow to use them as BMCP.

First, they can replace the injured or diseased recipient cells. Secondly, the therapeutic effect of the use of MSC can occur through the secretion of biologically active substances, and thirdly, the MSC can exchange biological material with the recipient’s cells, which can also have a therapeutic effect. [2]

Currently, the use of MSC is considered for the treatment of the following diseases: diabetic peripheral neuropathy, osteoarthritis, inflammatory diseases of the respiratory system, inflammatory bowel disease, multiple sclerosis, etc.

3. Requirements for the registration dossier for MSC.

According to the article of 2015, written by the collective of authors of FSBI “Scientific Center on Expertise of Medical Application Products”, the registration dossier on BMCP should contain the following data:

• Confirmation that the selection of donors was made in accordance with the current legislative acts of the Russian Federation.
• Confirmation of the completion of all stages of receiving the cell line in Class A rooms.
• Confirmation that the isolated cells belong to mesenchymal stromal cells of the donor.
• Confirmation of correctness and standardization of all methods of cell allocation from donor materials.

• Confirmation of the degree of homogeneity and maturity of the cell population, as well as confirmation of their mezenchymal nature when conducting a series of sequential passages for the production of material suitable for entering into bioreactors.
• Confirmation that the claimed cell line (read here about it) is a MSC line and can be used for therapeutic purposes.
• Cell Line Passport

In conclusion, it is worth noting that the requirements for the registration dossier (namely the normative documentation on BMCP) are certainly not limited to the data given above and will differ in the formation of a dossier on BMCP, which will include other types of cells.

References:

1. FZ № 180 “On Biomedical Cell Products”
2. Бурунова В.В., Васильев М.П., Ярыгин Н.В., Ярыгин К.Н. Перспективы применения препаратов на основе мезенхимальных стволовых клеток в терапии пост-трансплантационных осложнений, связанных с иммунной несовместимостью // Курский научно-практический вестник «Человек и его здоровье». №1. URL: https://cyberleninka.ru/article/n/perspektivy-primeneniya-preparatov-na-osnove-mezenhimalnyh-stvolovyh-kletok-v-terapii-post-transplantatsionnyh-oslozhneniy-svyazannyh
3. Супотницкий М.В., Елапов А.А., Меркулов В.А., Борисевич И.В., Климов В.И., Миронов А.Н. ОСНОВНЫЕ ТЕХНОЛОГИЧЕСКИЕ ПРОЦЕССЫ, ИСПОЛЬЗУЕМЫЕ ПРИ ПРОИЗВОДСТВЕ БИОМЕДИЦИНСКИХ КЛЕТОЧНЫХ ПРОДУКТОВ // БИОпрепараты. Профилактика, диагностика, лечение. 2015. №2 (54). URL: https://cyberleninka.ru/article/n/osnovnye-tehnologicheskie-protsessy-ispolzuemye-pri-proizvodstve-biomeditsinskih-kletochnyh-produktov