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CellgeneaTM offers unique validated services of high quality in:
- Preventive Cryopreservation of Progenitor Cells.
- Continuous offer of updated knowledge and validated education to the donors, as well as the medics for the application of the progenitor cells by specialized personnel (medics, pharmacists, biotechnologists).
- Continuous sample collection (progenitor cell collection ΚΙΤ) 365 days a year, 7 days a week, 24 hours per day according to ΙΑΤΑ regulations and the national regulations for the sample transportation.
- Collection, cell processing, and cryopreservation of progenitor hematopoietic cells from cord blood, as well as the adult stem cells, according to European regulations and the Greek Presidential Guideline 2004/23 for cell/tissue banks, according to cGMP sterile methods and procedures.
- Plasticity test of the progenitor cells after thawing of a small quantity of each sample (Methocult®).
- Automated Viability Test of the cryopreserved progenitor cells, using the full automated luminometric system (with repetitive and precise results) instead of the classical laboratory techniques using the Trypan Blue.
- Complete Microbiological and Serological control with no extra charge using the full automated analyzers BacT/ALERT (BioMérieux) και Architect i1000 (Abbott Diagnostics)(detection of HIV1/2, HBV, HCV, CMV, Syphillis, Toxoplasma). Molecular control in case of a contaminated sample (PCR).
- Cellgenea is the only company in Greece which uses validated ex-vivo cell expansion protocols for the processed cells, as well as the cryopreserved cells using advanced BioReactors (Regenetech) from the research laboratories of the NASA, in micro-gravity conditions and time-dependant electromagnetic field.
- Storage of the progenitor cells in two separable compartments cryobags (FDA approved) that allow for a 4:1 division of contents, as well as in cryotubes in fully monitored (24h per day) conditions.
- Continuous control and traceability of the cryopreserved samples with validated LIS-ERP software.
- Immediate release and delivery of the requested samples in case of a future therapeutic application.
- Strict Conformity to the Regulations of the Hellenic Data Protection Authority.
- Full record of the «serious side effects» and «serious reactions», which could lead to the transmission of an Infectious Disease, could cause death, could threaten a life etc.
- Therapeutic application solely for autologous use.
- Developing and applying of research and protocols using progenitor cells in the regenerative medicine and the supportive therapy of degenerative diseases such as the Acute and Chronic Myocardial Infraction and the Parkinson's disease with exclusive co-operation with European Transplant Clinics.
- Developing and continuous updating of patient record with specific exclusion-inclusion criteria for cellular therapy clinical trials according to EMEA.
- Validated services for the pre-natal and genetic control for the detections of any chromosomal and genetic mutations using peripheral blood, cord blood, tissues etc) in collaboration with the Technological Park of Ioannina, Greece.
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