Abstract
AIMS: Bone Marrow Concentrates (BMC) applied to treat several osteo-articular pathologies had reported positive clinical outcomes at short- to medium-term follow up. However, the diversity of indications reported and the lack of consensus describing the formulation of BMC make it difficult to circumscribe basic processing variables to generate them. We analyzed the influence of processing different Bone Marrow (BM) volumes over the formulation and deliverable cell dose of BMC. MATERIALS AND METHODS: Main cellular populations were characterized in BMC manufactured and applied for autologous use during the same surgical procedure. To do this, Flow Cytometry and Fibroblastic Colony Forming Units (CFU-Fs) assays were used. RESULTS: Cell concentration of aspirates was not statistically influenced in the range of volumes analyzed. Consequently the quality of BM seems to be conserved in the range of volumes assayed. By using the protocol described, the quality of BMC traditionally defined as CFU-F per mL did not differ in the range of volumes assayed whereas total dose of CFU-F and other differentiated cells effectively changed. CONCLUSIONS: The volume of BM defines cellular doses arriving to the patient with statistically significant differences. Parameters currently used to describe the quality of BMC as CFU-F/mL appear to be directly influenced by working volumes and thus total cellular doses applied might better characterize these products. Finally, since it is uncertain what cells within BMC form part of its active substance, the quantification of main cell subsets could be helpful to better understand where, when and how these medicinal products work.
Highlights
Intraoperatory delivery of bone marrow concentrates (BMC) for other functions than hematological reconstitution has been harnessed as an individualized therapy produced and applied during the same surgical procedure to treat diverse pathologies
Viability and total cell dose administered to patients in Bone Marrow Concentrates (BMC) for autologous use were quantified during the course of 109 surgeries (43 females; 66 males; mean age 48.4 ± 14.5 years)
The opportunity of using living cells contained in BMC as therapeutic tools is a very attractive approach due to the methodological simplicity and its compatibility with current surgical procedures
Summary
Intraoperatory delivery of bone marrow concentrates (BMC) for other functions than hematological reconstitution has been harnessed as an individualized therapy produced and applied during the same surgical procedure to treat diverse pathologies. BMC utilized in such a way have not been regulated in Europe so far[1,2] they perfectly meet the criteria to be considered as medicinal products In this regard, inversely to the developmental pathway of traditional drugs where high quality clinical studies are performed before its accessibility, BMC have fast moved from basic research to clinical practice even at the expense of not truly understanding intimate mechanisms associated to this therapy. One of the most accepted theories concerning BMC mode of action is related to the definition of its active substance In this regard Mesenchymal Stromal Cells (MSC) has been suggested to play a major role in BMCs reported therapeutic effects. Other differentiated cells administered along with MSC in BMC with known physiological paracrine activities might be involved in the mode of action of this cytotherapy[14-15]. This hypothesis really shifts the initial and somehow dogmatic belief about MSC as the unique active substance in BMC opening the possibility to include other cells as therapeutic drivers
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