1. Virological control
Abiding to the Greek legislation governing stem cells and human tissue banks, and according to the European Union Directive for the operation of cryopreservation banks (Commission Directive 2004/23 / EC and Commission Directive 2006/17 / EC), it is necessary to make a series of tests for specific viral infections in maternal blood before we can store stem cells for future use. The tests detect the following viruses and exclude the possibility of viral infection transmitted from the mother to the infant:
- AIDS (HIV I / II)
- Hepatitis B
- Hepatitis C
- Syphilis (TPHA or VDRL)
Nevertheless, the same tests are conducted in the hospital during pregnancy or just before delivery. It is necessary to provide us with a copy of these results at latest 10 days after delivery. If any of the above tests is not included in your own lab testing, please ask your doctor to include it. It is important for future parents to know that if any of the tests results is positive (i.e. there is an indication that mother is infected with one of these viruses) stem
cells cannot be stored.
Test results should be included in your baby’s cord blood collection kit upon delivery, to Omnigen’s representative. Alternatively you can mail them at: Omnigen, Kifisisas 1, 151 23, Maroussi or via fax to +30 2106810318.
2. Bacterial and fungal infections control
A very small amount of the umbilical cord blood is tested in our labs for contamination from aerobic and anaerobic bacteria and fungi in a special automated blood culture system. Infertility in a sample (i.e. no microorganisms) is a prerequisite for the future use of the stem cells for therapeutic reasons. That is why in the few cases of sample contamination by microorganisms we will not store the infected samples. It is important to understand that possible contamination is not related to the newborn, since the origin of the microorganisms identified in these samples is usually the skin (approximately 50% of cases), the vagina or the gastrointestinal tract, and the environment (air, water – few cases ~ 3%) *.
* Meyer1 TPH, et al. “Analysis and cryopreservation of hematopoietic stem and progenitor cells from umbilical cord blood”. Cytotherapy (2006) Vol. 8, No. 3, 265-276.
Omnigen is one of the few companies (if not the only one) in Greece owning such equipment and we are able to take all these laboratory tests for a detailed analysis of stored samples. It is worth saying that many stem cell banks send part of the original sample in other external laboratories for these tests, both because of the cost of the equipment but also because of the lack of experience of their scientific staff.
Omnigen’s scientific staff is fully trained, and obtained all the necessary experience in Greece and abroad for such laboratory tests.
3. Certificate of Storage
Upon completion of the cryopreservation process of stem cells (hematopoietic or mesenchymal), we issue a detailed certificate of storage. The certificate is sent to parents and includes detailed information of the following:
• Isolation of cells (methodology used)
• Laboratory test results (amount of nucleated and mononuclear cells, the number of CD34+ hematopoietic stem cells and virologic, bacteriological and fungal analysis).
• Cryopreservation details for long-term storage (gradual freezing, use of cryopreservative medium, storage temperature etc.)
• The certificate is accompanied by the detailed result of flow cytometry, which will be very useful in case of future stem cells transplant.