Michael Scarpone, Daniel Kuebler, Andrew Chambers, Carlo Maria De Filippo, Mariangela Amatuzio, Thomas E. Ichim, Amit N. Patel, Eugenio Caradonna

Scarpone et al. J Transl Med (2019) 17:10 | https://doi.org/10.1186/s12967-018-1750-x

Background: This study examined the quality of bone marrow aspirates extracted using a novel, FDA cleared method to optimally target cells from the inner cortical iliac bone surface without the need for centrifugation. This method employs small draws from a single puncture that promote only lateral flow from multiple sites (SSLM method). The study utilized the Marrow Cellutions bone marrow aspiration system (MC system) which is based on the SSLM method and compared the MC system directly to bone marrow concentrates (BMAC) generated by centrifugation of aspirates harvested with a standard aspiration needle.

Methods: Three direct comparisons were conducted evaluating the SSLM draws and BMACs derived from the same patient from contralateral iliac crests. The levels of TNCs/mL, CD34+ cells/mL, CD117+ cells/mL, and CFU-f/mL were compared between the various bone marrow preparations. The cellular content of a series of SSLM draws was also analyzed to determine the total nucleated cell (TNC) count and the concentration of mesenchymal stem/progenitor cells as measured by colony forming unit fibroblasts (CFU-f ).

Results: In direct comparisons with BMAC systems, SSLM draws yielded significantly higher CFU-f concentrations and comparable concentrations of CD34+ and CD117+ cells. In addition, the average quantity of TNCs/mL in a series of 30 patients utilizing the SSLM draw was 35.2×10(6) ±17.1×10(6) and the average number of CFU-f/mL was 2885±1716. There were small but significant correlations between the TNCs/mL and the CFU-fs/mL using the SLM method as well as between the age of the patient and the CFU-fs/mL.

Conclusions: The MC Device, using the SSLM draw technique, produced concentrations of CFU-fs, CD34+ cells and CD117+ cells that were comparable or greater to BMACs derived from the same patient. Given the rapid speed and simplicity of the MC Device, we believe this novel system possesses significant practical advantages to other currently available centrifugation based systems.

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The Marrow Cellution™ System is designed to minimize and eliminate the restrictive limitations associated with “point of care” processing systems which employ inefficient traditional aspiration trocar technology and are regulated as drugs “Advanced Therapies Medicinal Products (ATMP)”.  Marrow Cellution™ is a minimally invasive bone/cell enriched autograft access and retrieval system, which does not require additional manipulation or processing, it never leaves the sterile field and provides rich autograft without associated morbidity.

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