7 - Haematopoietic stem cells from umbilical cord blood
DEFINITION
Cells from the umbilical cord with the capacity to re-establish haematopoiesis.
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.
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%.
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.
RECIPIENT
Plastic bags able to withstand temperatures of -196ºC.
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.
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.
Shelf life
The time of conservation is indefinite.