Biogenea pharmaceuticals enables you to isolate and cryopreserve your bone marrow stem cells through a simple procedure, as a small blood volume (60-100 ml) is drawn from specialized personnel.
The service includes the following stages:
Collection: The collection of the initial amount of bone marrow is carried out only once by specialized personnel. The initial volume required is small. The collection is done with one or two syringes containing the necessary amount of anticoagulant and placed in the package suitable for the service (MarrowgeneaTM collection KIT). The collection KIT contains a unique barcode, so that there is complete traceability, as well as all the relevant forms that need to be completed by the donor. The collection kit reaches the laboratories of biogenea pharmaceuticals as soon as possible for further processing.
From the moment the collection KIT arrives at the company's laboratories, the aseptic treatment follows in the certified clinical laboratory of the company biogenea pharmaceuticals with the strictest specifications and under cGMP (Good Manufacturing Practice) conditions. All processing is performed directly and with protocols that are fully harmonized with international standards. The final product containing the donor's primordial hematopoietic stem cells can be used directly in the context of approved clinical trial or cryopreserved for possible future use.
Aseptic processing & stem cells isolation: From the moment the collection KIT arrives at the company's laboratories, the aseptic treatment follows in the certified clinical laboratory of the company biogenea pharmaceuticals with the strictest specifications and under cGMP (Good Manufacturing Practice) conditions. All processing is performed directly and with protocols that are fully harmonized with international standards. The final product containing the donor's primordial hematopoietic stem cells can be used directly in the context of approved clinical trial or cryopreserved for possible future use.
Quality control: All stages of processing are fully controlled. Using a sample from the bone marrow, a general blood test is performed on an automated hematological ananalyzer. Flow cytometry is then performed on a sample of the final product to assess the final concentration of total nucleated cells, primordial hematopoietic stem cells (CD45 + / CD34 +), as well as the viability percentage of the latter. In the final product that is cryopreserved, a viability test is performed on a minimal part of the sample, which is frozen and thawed especially for this purpose, with the state-of-the-art Promega GloMax luminometer. This system is the first (and only so far) in Greece. This process is certified and the results are controlled and fully repeatable, as they are independent of the human factor, unlike the Trypan Blue process.
Bacterial and serologic control: On each blood sample taken a complete microbiological and serological test is being performed . Microbiological testing includes liquid culture under aerobic and anaerobic conditions in BioMérieux BacT / ALERT automatic blood culture system. In case a positive sample is found, the microbial strain is identified and an antibiogram is performed. The serological test is performed on modern immunological analyzers and in case a positive sample is found, a molecular test is performed with RealTime PCR, to confirm or reject the seropositivity.
Long Term Cryopreservation and Release: Samples that are not used immediately follow the process of gradual freezing and long-term cryopreservation. A special cryo-resistant agent is used to prevent the formation of water crystals in the cells, which leads to complete destruction of the cells. With the certified gradual freezing the thermal and osmotic shock of the cells is being avoided and the final product is placed in suitable liquid nitrogen tanks (at temperatures down to -196 oC) for long-term storage. If there is a need to use the premordial hematopoietic stem cells, then the sample release procedure is followed, which requires the written consent of the donor and a written request from the carrier(public or private, domestic or not) that the autologous premordial hematopoietic stem cells are necessary for supportive cell therapy. In this case the sample is properly thawed to avoid thermal and osmotic shock of the cells and can now be administered to the patient by qualified personnel.
Therapeutic applications: Premordial hematopoietic stem cells can find applications in a great variety of haematological pathological conditions. Up to date,premordial hematopoietic stem cells have been used as therapeutic support for more than 70 hematological pathological conditions, such as: acute leukemias, chronic leukemias, myelodysplastic syndromes, aplastic anemias, myeloproliferative anomalies, lymphomas, multiple myelomas etc. Of course, it should be emphasized that since this is an autologous sample, it is not possible to treat hereditary genetic diseases, because the cells will carry the same mutations. In this case, autologous hematopoietic stem cells can be used for gene therapy and final use in the patient.
Clinical studies: There are published clinical studies of regenerative medicine in independent review journals on a variety of diseases such as acute myocardial infarction, stroke, brain paralysis and autism disorder with encouraging results. However, autologous bone marrow transplants are already used by patients undergoing chemotherapy, so that after cryopreservation and proper thawing after the end of the chemotherapy they are given to the patient, in order to reconstitute the hematopoietic system.
Collection and isolation of platelet-rich plasma
(PRP): Biogenea pharmaceuticals enables, in parallel with the isolation of premordial hematopoietic bone marrow stem cells, the isolation of platelet-rich plasma(PRP).PRP is a natural autologous blood derivative, which contains a number of growth factors (PDGF, TGF beta, EGF, VGF, etc.).Long-term research has shown that these high platelet concentrations can enhance healing of injuries and incisions of bone tissue and connective tissue.Its preparation requires taking a small amount of blood and is done quickly and easily.
Production of PRP: The isolation of PRP in biogenea pharmaceuticals is done with technologically advanced devices.The separation and collection of platelets is the result of gravitational forces, which are exerted on the blood for a certain period of time. . To isolate PPR a very small amount of blood (20-50 ml) is required. PRP action: The action of PRP is based on its ability to transport large numbers of platelets to the area of a deficit or lesion, where it releases significant amounts of growth factors, which promote the formation of a new vascular network and accelerate the normal healing processes of the human organism. It is a platelet concentrate that contains a variety of growth factors and can be obtained from the same donor.
Clinical studies: There are various clinical studies regarding the effect of PRP on a variety of grafts and alloplastic materials during sinus lift surgery, localized bone regeneration of the alveolar processes, restoration of extensive mandibular atrophies and periodontal defects. A number of studies have shown that the application of PRP in combination with bone graft materials appears to result in an increase in the rate and percentage of osteogenesis. The benefits of using PRP in combination with an autograft are particularly important. The clinical benefits of clinical use of PRP include the ability to insert and load implants more quickly, but also the improvement of the prognosis in the repair of bone defects in elderly patients with osteoporosis, type IV bone or patients undergoing radiotherapy. Recently, significant progress has been made in the use of PRP in human intraoral and maxillofacial surgery. Experimentally, it has been used in ophthalmology, cardiac surgery, plastic surgery, neurosurgery and hemostasis procedures.
PRP storage: Samples that are not used immediately follow the process of gradual freezing and long-term cryopreservation.
At biogenea pharmaceuticals we have made sure that this valuable service meets the financial capabilities of the Greek family.