Product Highlight

• The products have been granted with US FDA Class II Medical Device Registration with No.510(K): K232543.
• Serum-free medium kit for the primary isolation and expansion of mesenchymal stem cells (MSCs) derived from a variety of tissue sources. A 20 cm long normal umbilical cord can harvest 2.4x10⁷cells in primary isolation and maintain stable cell characteristics through continuous passages to P20.
• A truly serum-free pure factor system, with no human-derived or animal-derived components, for which biocompatibility and toxicity experiments have been specifically conducted to guarantee the safety of the culture medium, and with more focuses on safety.
• Suitable for declaration of stem cell drugs: the product performance is witnessed during business cooperation with dozens of clinical hospitals and pharmaceutical companies.

Product Information

This culture medium can be used for the primary cell isolation, seed - bank construction, and continuous subculture of human mesenchymal stem cells from various sources, while maintaining their multi – lineage differentiation potential, such as bone marrow (BM - hMSC) and umbilical cord (UCM - hMSC). No serum or serum substitutes are required when using this product.

This product has a well-defined chemical composition, with no added serum or serum substitutes (platelet lysate), and no components of animal or human origin. There is little batch - to - batch variation. All raw materials meet GMP standards, making it more suitable for clinical research purposes.

Product Specifications:

Osmotic pressure	280-350mOsm/kg
Endotoxin	<0.25EU/mL
Sterility	Bacteria and fungi shall not be detected
Mycoplasma	shall not be detected
pH	6.8-7.8
Appearance	Light yellow - yellow clear and transparent liquid
Volume	500mL/bottle

Special Instructions Before Use

1. The usage method of this product is indeed different from that of serum - containing culture media and serum - substitute culture media.

We kindly request users to carefully read the instruction manual of this product before operation. Please do not use this product solely based on experience.

Compared with serum - containing culture media and serum - substitute culture media, certain details of the existing operations have been standardized. (For example, there are clear requirements for the operation method of adding the culture medium to the culture flask or petri dish.)

2. This product does not contain a trypsin inhibitor and cannot be used to terminate trypsin digestion. Serum and serum substitutes (platelet lysate) contain antithrombin III, which can inhibit the digestive effect of trypsin. This is why serum can terminate trypsin digestion. It is also the reason why MSC cells in serum - containing culture media must be washed with PBS before digestion (to remove residual serum) during subculture.

When using this product, it is recommended to use GMP - grade stem cell mild digestive enzyme (a supporting product, product number: LNC1004.1) to digest cells. This method does not require an inhibitor for termination. After dilution with the culture supernatant, the cells can be collected by centrifugation to remove the supernatant. Moreover, it causes no damage to the cells within 10 minutes, and the harvested cells have a high viability. The multiple amplification remains at a relatively high level after sub - culture, avoiding the problem of trypsin residue after cell digestion.

Thawing and Continuous Passage Culture Data for Cryopreserved P2 Cells (150mm dishes)

Passage	Cells harvested per dish	Increase by folds	Seeding density (cells/cm2)	Culture time
P3	1.50E+07	12.52	8000	3 Days
P4	1.68E+07	14		3 Days
P5	1.59E+07	13.22		3 Days
P6	1.33E+07	11.07	10000	3 Days
P7	1.34E+07	11.03		3 Days

Data on Isolation and Continuous Passage Culture of Primary Umbilical Cord MSCs

Passage	Initial cells	cell culture type	Number of tissues per dish	Culture Time
P0	3.68E+06	150mm dish	35	14-16 days
		Increase by folds	Seeding density (cells/cm2)
P1	1.50E+07	10	8000	3 Days
P2	1.36E+07	11.29		3 Days
P3	1.53E+07	12.75		3 Days
P4	1.39E+07	11.55		3 Days
P5	1.21E+07	10.08		3 Days
P6	1.54E+07	10.28	10000	3 Days
P7	1.75E+07	11.64		3 Days
P8	1.50E+07	10		3 Days
P9	1.73E+07	11.56		3 Days
P10	1.45E+07	9.64		3 Days