Research Article
Peter A. Everts, John Ferrell,
Abstract
The first aim of this study was to examine the cellularity and quality of autologous bone marrow aspirates harvested with two novel FDA-cleared devices, namely the Aspire™ bone marrow aspiration system (AS-BMAS) and the Marrow Cellution bone marrow aspiration device (MC-BMAD). Compared to traditional bone marrow harvesting needle systems, both these devices have a closed distal tip, avoiding preferential marrow collection (peripheral blood aspiration) from deeper cavity regions, whereas the side holes facilitate more horizontal marrow extraction. In all patients, a similar harvesting technique was used. The second aim was to demonstrate the effectiveness of mechanical centrifugation of a large volume of extracted bone marrow to produce a bone marrow concentrate (BMC). Finally, we directly compared bone marrow constituents aspirated with MC-BMAD with a BMC, generated by centrifugation of bone marrow harvested using the AS-BMAS. A bi-lateral patient model was used for all comparisons. All cellular analyses included the measurement of Colony-Forming Units-fibroblasts (CFU/f) levels, CD34+cells/ml, Total Nucleated Cells (TNCs)/ml, platelets/ml, and Red Blood Cells (RBCs)/ml in a single, FDA-approved laboratory, compliant with Good Manufacturing Practice regulations. A total of 12 patients consented to the study. In the direct BMA comparison, the AS-BMAS bone marrow yielded significantly higher CFU/f counts and TNC concentrations than the MC-BMAD (1,060/ml, 33.5 × 106/ml, and 610/ml and 28.6 × 106/ml, respectively), with comparable platelet and RBC concentrations. Data following BMA concentration to produce a BMC revealed highly significant cell yields, fewer RBCs, and lower hematocrit (HCT). A direct cellular comparison between the aspirate of the MCBMAD and centrifugated BMC following AS-BMAS marrow extraction showed highly significant differences in cellularity. The AS-BMAS produced cell concentrations of CFU/f, CD34+ cells, TNCs, platelets, and RBCs that were comparable, or greater than, the predicate device. We believe that concentrating bone marrow is a consistent and safe method to produce a BMC that has the potential to be clinically effective. Furthermore, data indicate a non-equivalent difference in BMC cellularity, when compared to a non-filtered and non-centrifugated BMA for clinical use.