Extensive work was done in the preclinical setting (large pig model), to evaluate the harvest system and compare to the standard trocar method.
Evaluation demonstrated the safety, and efficacy of the technology, in which higher total nucleated cells per ml, and 10-20X more Mesenchymal Stem Cells (MSC) were obtained compared to normal aspiration methods.
The system was FDA 510(k) cleared and First-In-Man trials were successfully completed, demonstrating safety, efficacy and higher stem cell yields compared to traditional methods.
In 20 patients the MM successfully harvested marrow from a single entry site under local anesthesia, without any complication, from both anterior and posterior entry sites on the patient’s iliac bone. Compared to standard harvest in the same patients, significantly higher total nucleated cell counts and CD34+ cells/ml were obtained using the MM, with equivalent viability (>98%). In addition to higher TNC/ml, higher numbers of ALDH+ cells/ml, phenotypic Mesenchymal Stromal Cells (MSC), and endothelial progenitor cells were obtained withthe MM than by traditional methods, as measured by flow cytometry.