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7 - Haematopoietic stem cells from umbilical cord blood
dot DEFINITION
Cells from the umbilical cord with the capacity to re-establish haematopoiesis.
dot HOW IT IS OBTAINED
Obtained during childbirth after the birth of the baby and before the separation of the placenta, by perforating the umbilical cord with a needle connected to the bag. In all cases the mother must fulfil the established selection criteria.
dot COMPOSITION AND CHARACTERISTICS
Before treatment, the product obtained must weigh more than 70 g and have more than 0.32 x 109 mononuclear cells.
Cell viability after thawing must be above 60%.
dot RESULTS OF ANALYSIS  

Results from the mother:

• Hepatitis B surface antigen (HBsAg): negative
• Hepatitis C virus antibodies (Anti-HCV): negative
• Human immunodeficiency virus anti-bodies (Anti-HIV 1/2): negative.
• Lues serology: negative
• HCV RNA (PCR): negative.
• Antibodies against CMV IgM: negative


Product results:

• Aerobic and anaerobic bacteriologic culture and fungus culture of the original and final products: negative.


A positive result for microorganisms of low pathogenesis does not exclude the product for use. In this case, the doctor responsible for administering the product is informed of the result.
dot RECIPIENT
Plastic bags able to withstand temperatures of -196ºC.
dot IDENTIFICATION   
Through a label with the identification number
The product is accompanied by a report with the following data referring to the product after thawing: quantity of mononuclear cells and CD4 positive cells, number of CFU-GEMM, cell viability and culture results.
dot CONSERVATION
Freezing at a temperature of below -120º C.
The freezing process includes a previous step involving the addition of a cryoprotecting solution (10% DMSO) and the programmed freezing with the temperature decreased at a rate of 0.5-3ºC per minute. After freezing the DMSO is eliminated by means of a cleaning process.
dot Shelf life
The time of conservation is indefinite.


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Other TISSUE AND CELL THERAPY products arrows
1 Corneas
2 Sclerotic coat
3 Skin
4 Vascular segments
5 Osteotendinous tissue
6 Peripheral-blood haematopoietic stem cells
7 Haematopoietic stem cells from umbilical cord blood
8 Treating blood stem cells
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