ANGIO BANK™

Collection, processing, and “long-term” cryopreservation of hematopoietic stem cells and immune cells from adult peripheral blood.

The procedure consists:

Collection:

Not mobilized peripheral blood (100 c.c) 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 ...

Not mobilized peripheral blood (100 c.c) 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 are packaged inside the appropriate collection kit (AngiogeneaTM collection KIT). The ΚΙΤ is marked with a unique barcode, so that a continuous traceability exists and includes all the relevant documents that must be filled by the donor. The collection KIT is transferred immediately to the laboratories of Biogenea Pharmaceuticals Ltd for further processing.

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Processing:

Immediately after the arrival of the collection KIT at the laboratories of the company, it is unpacked and processed in a sterile environment under GMP conditions (Good Manufacturing Practice). The whole process is carried out directly with validated protocols according to the international ...

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

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Quality Control:

Each and every processing step is fully monitored. A small quantity from each sample is analyzed in an automated blood analyzer. Finally, Flow Cytometry is used to determine the final concentration of the total nucleated cells, the hematopoietic stem cells (CD45+/CD34+) and the cell viability ...

Each and every processing step is fully monitored. A small quantity from each sample is analyzed in an automated blood analyzer. Finally, Flow Cytometry is used to determine the final concentration of the total nucleated cells, the hematopoietic stem 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. Fully automated system has the advantage that its protocols are validated and the produced results are controlled and reproducible. Each collected sample undergoes full microbiological and genetic control. The microbiological control includes liquid culture in aerobic and anaerobic conditions using the automatic system.When a contamination is found in a sample, identification follows through an antibiogram. RealTime PCR is used to verify and identify the pathogen that is possibly detected in the serum of the sample.

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Long term Cryopreservation & Product Release:

Only after the completion of all the quality tests isolated Hematopoietic stem cells are stored in temperatures reaching the -196C ( in these conditions all the metabolic procedures are stopped ) and document/certificate of cryopreservation is issued.

Ex-vivo hematopoietic stem cell expansion:

Biogenea Pharmaceuticals Ltd uses patented technology for the ex vivo hematopoietic stem cell expansion up to Total Nucleated Cells (x100 folds) and CD45+dimCD34+ hematopoietic stem cells (x10 folds). As a result, the isolated hematopoietic stem cells could be expanded in case of a future therapeutic use.

What can you do with it:

Due to the continuous advances in the future applications of the hematopoietic stem cells for therapeutic uses, the fact that these cellular populations are being used for many years for the treatment of immune diseases as well as a supporting treatment for some cancers, is being ignored. In ...

Due to the continuous advances in the future applications of the hematopoietic stem cells for therapeutic uses, the fact that these cellular populations are being used for many years for the treatment of immune diseases as well as a supporting treatment for some cancers, is being ignored. In particular, after specific treatments such as chemotherapy or irradiation (that destroy the immunological system after cancer therapy or irradiation accident exposure) a blood system reconstruction is needed. 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. There are no published results from clinical trials yet, given that the process of progenitor hematopoietic cells from non mobilized 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.

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