BC60 Pure  - Pure Bone Marrow Concentrating System 60mL

BC120 Pure - Pure Bone Marrow Concentrating System 120mL


GSBMA60 544E - Standard Bone Marrow Concentrating System 60mL

GSBMA120 544E ​Standard Bone Marrow Concentrating System 120mL






RESULTS:


Characterization of GenesisCS BMC:The TNC values from the hematology analyzer for pre-sample (BMA) and for product (BMC) and the calculated concentration over baseline values are shown in Table I.






Table II lists the calculated total number of cells (volume x concentration) in BMA and BMC. TNC and PLT counts represent the values from the hematology analyzer times the volumes of BMA or BMC. HSC numbers are calculated from the percent of CD34+ cells gated with CD45+ events times the number of WBC (TNC minus nucleated red blood cells).


Performance Evaluation

GenesisCS Bone Marrow Concentrate (BMC)

The GenesisCS BMC system delivers a quality product for all regenrative needs. Cell isolation is optimized with a protocols usually a gradient centrifugation. Offering a concentration of regenerative cells in as little as 10 minutes. Recovering a large percentage of platelet rich plasma, stem cell and nucleated cells in a 5-10ml treatment sample. Efficient, durable and conducted in a closed system results in a safe are consistant product


TEST OBJECTIVE:


Preliminary evaluation of GenesisCS for concentration of human bone marrow aspirate.  Preclinical and clinical studies have suggested the benefit of using concentrated autologous platelet rich plasma from bone marrow aspirate in bone repair.  It has been suggested that bone marrow aspirate is often not sufficient for clinical efficacy in the absence of concentration.  This report represents results from an evaluation of GenesisCS device for the concentration of autologous platelet rich plasma from human bone marrow aspirate. Sixty mL of human bone marrow aspirate were concentrated to approximately 6 ml of PRP with the GenesisCS. Samples of the bone marrow aspirate (BMA) and resulting bone marrow concentrate (BMC) were analyzed for Total Nucleated Cells (TNC), Platelets (PLT), and CD34 positive Hematopoietic Cells (HSC).  Yield calculation were done for TNC, PLT and HCS. ​



​DISCUSSION:


The percent of TNC, PLT, and CD34+ HSC were calculated by dividing the total number of cells recovered in the BMC by the total number present in 60ml of BMA and are represented as mean plus standard deviation for 2 donors with duplicate runs. CONCLUSION:The product (BMC) yields were 76% for TNCs and CD34+ HSC. These yields are consistent with other point of care bone marrow concentrating devices. Platelet yields in the BMC averaged 70% and the product Hematocrit averaged 31.6% with a range of 31-40% (data not shown). Hematocrit can be adjusted by including more or less of the plasma layer during the collection of BMC. Variation within donor samples appears to less than between donors. Between donor variation will need to be determined in a larger study. However, the data from this preliminary evaluation with two donors run in duplicate, is very encouraging

Bone Marrow Concentrate  ​

Cells derived from the bone marrow show various therapeutic effects as a source of highly concentrated mesenchymal stem cells, Hematopoietic stem cells and various cytokines such as those found in Platetet Rich Plasma. Unlike peripheral blood withdrawal, autologous bone marrow must be harvested by a licensed medical professional in a sterile surgical setting.

Bone Marrow Concentration