Omnigen fully implements the Greek legislation governing stem cells banks of human tissue, applying the European guidelines which dictate the operation protocols for the cryopreservation banks (Commission Directive 2004/23 / EC and Commission Directive 2006/17 / EC). These guidelines are dictating the procedures for the collection, processing and storage of stem cells from the umbilical cord but also for the strict laboratory tests made, in order to test the suitability of each sample for long term cryopreservation. Our laboratories are fully operating under these directives.
Under the EU guidelines for the operation of cryopreservation banks, in order to ensure that stem cells to be stored for future use are not contaminated, a series of tests for specific viral infections in the mother’s blood are performed. The tests relate to the following viruses and exclude the possibility that the mother bears viral infection which can be transmitted to the infant:
- AIDS (HIV I / II)
- Hepatitis B
- Hepatitis C
- Syphilis (TPHA or VDRL)
One of the most complex test is hepatitis B. Usually, during pregnancy, to check if mother is infected with hepatitis B virus, we control three indicators: anti-HBc, anti-HBs and HBsAg (also known as the Australian antigen ). By the analysis of the results we are in position to determine with high probability if a woman is infected with the hepatitis B virus. If mother is found positive in Australian antigen (HBsAg), this means that there is a high probability that the virus is active in the maternal blood. In this case, the sample cannot be stored, since the stem cells cannot be used in the future. If one of the other two indexes (anti-HBc, anti-HBs) found positive, while the Australian antigen (HBsAg) is negative, in order to decide to store the stem cells for future use, full analysis in maternal blood must be performed for hepatitis B.
In conclusion, it is important for future parents to know that if any of the tests performed by Omnigen or during pregnancy in the hospital is positive (i.e. if there is indication that the mother is infected with one of these viruses ), then it may be impossible to store child’s stem cells, since they cannot have future use. Our company strictly abides to the European directives for the above tests, so to ensure stem cells stored in our facilities will have future use in any hospital.