Pre-clinical assessment of the Lovo device for dimethyl sulfoxide removal and cell concentration in thawed hematopoietic progenitor cell grafts.

ABSTRACT

BACKGROUND: Cryopreserved hematopoietic progenitor cell (HPC) grafts are widely infused to patients with malignant and nonmalignant conditions. Despite reduction of immediate side effects linked to dimethyl sulfoxide (DMSO), cell debris-containing grafts and comparable hematopoietic engraftment between washed and unwashed cryopreserved products, bedside infusion of thawed HPC grafts is still preferred. Introduction of automated devices is important for standardization and consistency of graft manipulation. Additionally, these techniques are likely to be useful for the delivery of innovative cell-based medicinal products that are currently under development. METHODS: In this study, we evaluated three consecutive versions of the Lovo device (Fresenius Kabi) for automated washing of thawed HPC products. A total of 42 HPC products intended for destruction were used. Measured outcomes included viable CD34+ cell recovery, viability, total processing time and post-washing stability. RESULTS: Preliminary data using the prototype Lovo 0.0 to process a single HPC unit showed better recovery and viability of CD34+ cells using a two-cycle than a three-cycle wash, with >95% DMSO elimination. The Lovo 1.0 performed equally well. When simultaneously processing two HPC units, the upgraded Lovo 2.0 device demonstrated comparable CD34+ recovery, DMSO elimination efficiencies and time-saving capacity. Furthermore, washed cell products were stable for 4 hours at room temperature. DISCUSSION: Lovo device satisfies clinically relevant issues ability to efficiently wash two HPC units simultaneously and compatibility with transport to nearby transplantation centers.