Marrow Cellution™ accesses aspirate flow collected exclusively laterally as the tip of the aspiration cannula is closed allowing marrow collection perpendicular to and around the channel created by the tip of the device. It incorporates technology to precisely reposition the retrieval cannula within the marrow space after each aspiration. These features achieve a clinicians' desire for a single entry point. A single puncture with Marrow Cellution™ provides high quality bone marrow aspirate and bone graft, collected from numerous sites within the marrow geography. Marrow Cellution™ provides substantial savings of effort, time and expense. It reduces patient trauma, morbidity and risk of infection
Marrow Cellution™ maximizes stem and progenitor cell recovery and minimizes peripheral blood infiltration. Trocar needles with side ports aspirate primarily through an open-ended cannula. This leads to excess blood collection, requiring additional manipulation, i.e. centrifugation or chemical separation in a laboratory.
In addition, because there is reduced peripheral blood infiltration in bone marrow harvesting, Marrow Cellution allows the clinician to keep the product entirely on the sterile field rather than requiring the product the leave the sterile field for centrifugation and re-enter the sterile field for administration in the patient, reduces time for the final product to be delivered to the patient (no centrifugation necessary), reduces procedural expenses, and retains all the cells and growth factors obtained in the aspiration.
Use of centrifuged bone marrow aspirate for regenerative medicine is a growing practice; however, such centrifugation systems require aspirating large volumes (30-240 mL) in order to obtain sufficient stem/progenitor cellularity in a large enough post-centrifugation final volume for therapeutic administration. It is well known that the highest quality (highest quantity of stem/progenitor cells) bone marrow aspirations require aspirating small volumes of bone marrow (1-2 mL).
The need for centrifugation, and consequent volume reduction, is due to the limitations of the traditional bone marrow aspiration needle. Blood and marrow are non-Newtonian fluids and the traditional needle has a large open port at its distal end; as such, it is known that peripheral blood infiltrates bone marrow aspirates greater than 1-2 mL. Marrow Cellution™ (Ranfac, Avon, MA), a novel bone marrow access and retrieval device requires substantially less bone marrow aspirate, the limitations of standard bone marrow aspiration needles (e.g., reduced stem/progenitors cell concentrations due to dilution with peripheral blood) are substantially overcome. Further, the single step Marrow Cellution™ produced the same (as counted by CD34+ cells) or greater (as counted by fibroblast-like colony-forming units, CFU-f) stem/progenitor cell concentrations as a combination of traditional needles and centrifugation with the SmartPReP2 Bone Marrow Aspirate Concentrate (BMAC) centrifuge-based 2 cellular processing system (Harvest Technologies, Plymouth, MA).
Marrow Cellution™ achieves multiple small volumes of high quality bone marrow aspirate collected from various sites distributed within the marrow cavity.
A single puncture with Marrow Cellution™ is functionally equivalent to repeated puncture sites with a traditional trocar needle collecting small aspirate volumes, but with substantial savings of time, effort, reduced patient trauma, morbidity and risk of infection.
There is no constant ratio between average marrow cellularity as measured by number of total nucleated cells per mL and the number of CFU-f. Hernigou et al in several authoritative studies linked clinical outcomes in non-union and osteonecrosis to the number of CFU-f cells in the graft.
Controlling for volume, Hernigou et. al. noted that 70% of the variation in CFU-f from patient to patient was due to variations in the quality of the marrow aspirate or idiosyncratic to the patient with the remaining variation being due to the of number of nucleated cells per mL in the aspirate.
Statistically, the only variable Hernigou reported to be significant was CFU-f and not nucleated cells per mL. Interestingly, CFU-f is found frequently in marrow and very rarely in peripheral blood.
“Therefore, it seems reasonable to suggest that a graft needs to contain greater than 1000 progenitors/cm3” (P. Hernigou).