Angiogenea^TM

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Angiogenea is the novel service of Biogenea-Cellgenea Ltd that provides the chance to isolate hematopoietic progenitor cells from immobilized peripheral blood (blood without the administration of bone marrow mobilizing agents to increase the white blood cell numbers) of adult people, for cryopreservation and future use after ex-vivo cell expansion in the modern bioreactors of Regenetech applying NASA know-how.

The process is simple, as it includes only a single blood collection (20-40 ml) by specialized personnel. This service includes the following steps:

Collection: Not mobilized blood is collected only once by trained personnel. The quantity of the collection doesn't exceed the blood volume required for a complete hematological and immunological check-up. The blood is collected with one or two syringes that contain the appropriate amount of anticoagulant and these are packaged inside the appropriate collection kit (Angiogenea^TM collection KIT). The ΚΙΤ is marked with a unique barcode, so that the sample remains traceable throughout the whole processing, and includes all the relevant documents that must be filled by the donor. The collection KIT is transferred immediately to the laboratories of Biogenea-Cellgenea Ltd. for further processing.

Sterile processing & Isolation of hematopoietic progenitor cells: Immediately after the arrival of the collection KIT at the laboratories of the company, it is unpacked and processed in a sterile environment inside the Cleanroom (ISO 14644), under GMP conditions (Good Manufacturing Practice). The whole process is carried out directly following validated protocols according to the international regulations and specifications. The final product can either be administered immediately after ex-vivo cell expansion in the bioreactors or can be frozen and cryopreserved for future use.  

Quality control: Each and every processing step is fully monitored. A small quantity from each sample is analyzed in an automated blood analyzer. Finally, cell flow cytometry is used to determine the final concentration of the total nucleated cells, the progenitor hematopoietic cells (CD45⁺/CD34⁺) and the cell viability of the final product. An inconsiderable amount of the preserved final product is stored extra and thawed after a couple of days in order to control the viability of the corresponding cryopreserved sample. The very modern Glomax system by Promega is used for this task. This fully automated system is the first one installed in Greece and has the advantage that its protocols are validated and the produced results are controlled and reproducible.

Microbiological and serological control: Each collected sample undergoes full microbiological and serological control. The microbiological control includes liquid culture in aerobic and anaerobic conditions using the automatic system BacT/ALERT by BioMérieux. When a contamination is found in a sample, identification follows through an antibiogram. The serological control is carried out in the automatic immuno-analyzer Architect i1000SR, which is the first one installed in Greece. RealTime PCR is used to verify and identify the pathogen that is possibly detected in the serum of the sample.

Ex-vivo cell expansion:

{mosimage} The samples that must be used immediately undergo ex-vivo cell expansion inside modern bioreactors of Regenetech with validated protocols of NASA. In this way, up to 200-fold expansion of the cells can be obtained within only a couple of days, in order to achieve the appropriate number of cells for the application. After successful thawing, cell expansion is also possible for the cells that have been cryopreserved.

Long term Cryopreservation and Release: The samples that are not used immediately undergo the process of gradual freezing and long term cryopreservation. A special cryoprotection agent is used to prevent the formation of water crystals, which would damage and destroy the cells during thawing. Applying validated gradual freezing techniques, the cells avoid the thermal and osmotic shock and the final product is stored in special tanks filled with liquid nitrogen (-196⁰C) for long term storage. In case of an emergent use of the progenitor cells, the standard procedure of release is being followed. This procedure demands a written consent of the donor and written application from the appropriate agency (public or private, domestic or not) that the autologous progenitor cells are necessary for the supportive cellular treatment. In this case, the sample is appropriately thawed in order to avoid thermal and heat shock of the cells, and is administered to the patient by specially trained personal.

Therapeutical applications: The hematopoietic progenitor cells can be used for a variety of hematological pathologies. The application of adult cells decreases the possibility of neoplasia, as has been shown by recent studies. Neoplasia is a more common problem when embryonic progenitor cells are used, thus many ethical problems arise for their application.

Until today, the hematopoietic progenitor cells have been used as a therapeutical support for more than 70 hematological pathologies, such as: acute and chronic leukemia, myelodysplastic syndrome, aplastic anaimia, disorders of bone marrow and lymph, multiple myeloma etc. It must be noted that in case of inherited genetic diseases, autologous cells cannot be used because they will be carrying the same mutations. However, through gene therapy, these autologous progenitor cells can be applied on the patient.

Clinical trials: There are no published results from clinical trials yet, given that the process of progenitor hematopoietic cells from immobilized peripheral blood is still very new internationally. However, autologous samples are already administered on patients that undergo chemotherapy. Thus, after cryopreservation and successful thawing the cells are used on the patient so that hematological parameters recover faster.