Cellgenea

Familial storage of umbilical cord blood stem cells

Biogenea pharmaceuticals is the first and largest Greek pharmaceutical biotechnology company active in the innovative field of preventive storage of stem cells of the umbilical cord.

Biogenea pharmaceuticals focuses on the following areas:

  • In the collection, processing and cryopreservation of stem cells from the blood and the body of the umbilical cord for exclusively autologous use.
  • In the production of cellular therapeutic solutions for human use.
  • In the provision of certified cellular and genetic analyses.
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WHAT ARE

Stem cells of the umbilical cord

They are primordial undifferentiated cells characterized by the ability to regenerate and differentiate into many cell types of the organism.

There are two main types of stem cells isolated from the umbilical cord:

01

HEMATOPOIETIC STEM CELLS


The hematopoietic stem cells of the umbilical cord blood, that can be used as a hematopoietic graft alternative to the bone marrow for the reconstruction of the hematopoietic system
02

MESENCHYMAL STEM CELLS


The mesenchymal stem cells of the umbilical cord perivascular tissue and Wharton’s Jelly which can be used supportively for the regeneration, reconstruction or repair of damaged tissues and organs

PROCEDURES

The umbilical cord blood is collected from the umbilical vein.
The taking occurs immediately after labor and after the new born is cut off from it. The collection of blood does not burden the labor process at all. The collection is done by the OB and the method is the same in both normal delivery and caesarean section. The blood is transported in a special package that protects the content from radiation and mechanical damage. With special thermostatic gels the temperature is kept constant until the transfer to the laboratory.

The sample is identified by a unique code. Processing begins upon receipt of the sample in the laboratory. The fraction of the blood that contains the stem cells gets isolated. Laboratory areas are of graded purity.The most important steps are done in accredited “clean laboratories” (cleanroom class A / B), in accordance with EU directives.

Quality control: General blood test in an automatic hematological analyzer. Flow cytometry, for the calculation of the number of stem cells.

Bacterial control: Liquid culture under aerobic and anaerobic conditions, in BioMérieux’s automatic BacΤ / ALERT system. In a positive sample, the strain is identified and an antibiography is given.

Serological test: Performed on the most modern immunological analyzer Architect i1000SR

Detection of Australian antigen (HBsAg), nuclear antibody (anti-HBc) to hepatitis B, as well as antibodies to hepatitis C, AIDS virus, toxoplasma, syphilis, HTLV and cytomegalovirus CMV. In a possitive sample a Real Time PCR molecular test is performed to confirm or reject sample seropositivity. The seropositive samples are discarded.

The ISHAGE guidelines for CD34+ cell determinationby flow cytometry. International Society of Hematotherapy and Graft Engineering. Sutherland DR et.al., J Hematother 1996, 5: 213-226.

A minimum amount of sample is frozen and thawed separately to test stem cells viability. Thawing does not affect in any way the main quantity of the specimen. This procedure certifies that viability is not affected during cryopreservation.Viability is tested with Promega’s automatic Glomax system (the first and only one in Greece so far).
Adherent cells generated during long-term culture of human umbilical cord blood CD34+ cells have characteristics of endothelial cells and beneficial effect on blood ex vivo expansion. Yoo E et.al., Stem Cells 21Q 228-235, 2003 Evaluation of Assay and Workflow Performance of the Analyser

Adherent cells generated during long-term culture of human umbilical cord blood CD34+ cells have characteristics of endothelial cells and beneficial effect on blood ex vivo expansion. Yoo E et.al., Stem Cells 21Q 228-235, 2003 Evaluation of Assay and Workflow Performance of the Analyser

STEM CELLS

Biogenea pharmaceuticals clinical programs

The biogenea pharmaceuticals’ clinical team focuses on the following areas with responsibility & safety:

  • Design, study and implementation of research and pre-clinical protocols based on stem cells in the supportive treatment of degenerative diseases, such as chronic myocardial infarction (CardiogeneaTM) and Parkinson's disease (NeurogeneaTM) in exclusive collaboration with clinics in Greece and abroad.
  • Creation and update of patient’s register with specific selection criteria for participation in clinical cell therapy trials, under the guidance of reputable and experienced physicians.

Diseases treated with the use of stem cells

Since 1988, umbilical cord blood has been used to treat serious diseases. However, stem cell research is such that the number of diseases and injuries that can be treated with their use is constantly increasing.

STEM CELLS

Current therapeutic applications

  1. Acute diphenotypic leukemia
  2. Acute lymphocytic leukemia
  3. Acute marrow leukemia
  4. Acute undifferentiated leukemia
  5. T leukemia/addult lymphoma
  6. Chronic lymphocytic leukemia
  7. Chronic myelogenous leukemia
  8. Hodgkin lymphoma
  9. Non-Hodgkin lymphoma
  10. Juvenile chronic myelogenous leukemia
  11. Juvenile myelomonocytic leukemia
  12. Multiple myeloma
  13. Acute NK cell leukemia
  14. Pellocytic leukemia
  15. Waldenström macroglobulinemia
  1. Brain tumors
  2. Ewing Sarcoma
  3. Neuroblastoma
  4. Ovarian cancer
  5. Kidney cancer
  6. Rhabdomyosarcoma
  7. Microcellular carcinoma of the lung
  8. Testicular cancer
  9. Thymoma
  10. Bone marrow disturbances
  11. Hemoglobinopathies
  12. Histiocytic disorders
  13. Myelodysplastic / Myeloproliferative disorders
  14. Metabolic dissorders
  15. Immunological dissorders
  1. Brain lesions
  2. Central paralysis
  3. Diabetes melitus type 1
  4. Cardiopathies

Source: Umbilical Cord Blood Donor Foundation, USA
www.cordblooddonor.org

THE ULTIMATE SOLUTION FOR THE GREEK FAMILY

FOR STEM CELL STORAGE

Biogenea pharmaceuticals provides unique panhellenic certified high quality services in the following areas:

  • Biogenea pharmaceuticals constitutes the ONLY company in Greece that can proliferate and use ex-vivo expanded stem cells for therapeutic applications and clinical studies.
  • Continuous information and valid training on the applications of stem cells to interested donors and treating clinical doctors of public and private health centers and hospitals by specialized doctors, pharmacists and biotechnologists.
  • Immediate collection of samples (Stem cell KIT) 365 days a year, 7 days a week, 24 hours a day, in accordance with IATA regulations and guidelines of national biological transport regulations.
  • Automated viability testing of cryopreserved stem cells with an ultra automated luminosity system which increases the reproducibility and accuracy of the results in contrast to the standard laboratory techniques for detecting necrotic cells microscopically with the Trypan Blue dye.Certified provision of molecular diagnostic services (HIV1 / 2 detection, HBV, HCV, CMV, Syphillis, HTLV I / II, Toxoplasma) using Real-Time PCR.
  • Storage of stem cells either in two-chamber bags or in cold-resistant vials in fully (24-hour basis) controlled and automated conditions.
  • Constanti control and cross-traceability of cryopreserved samples with certified scientific software that fully ensures the ability to locate and identify the sample during any stage of its procurement, processing, testing, storage and distribution.
  • Immediate availability and distribution of the sample in case of future therapeutic application using a certified cryopreservation.
  • Strict protection of personal data, confidentiality and security in accordance with the principles of personal data protection.
  • Complete bacteriological and serological control of the samples without any additional burden on the automatic BacT / ALERT analyzers.