Evaluation of the gemini infusion pump for the safe delivery of peripheral blood progenitor cells (Stem Cells)

The purpose of this in vitro study was to determine whether the Gemini PC-2TX infusion pump could safely deliver peripheral stem cells (PSC) for an autologous PSC transplant. For purposes of hypothesis testing, it was assumed that there would be no significant difference in CD34+ cell counts and colony-forming units-granulocyte, macrophage (CFU-GM) when the PSCs were administered by an IMED PC-2TX infusion pump as opposed to an intravenous push method. The American Red Cross collected 50-ml samples of PSCs from four donors by apheresis. These cells were tested for CD34+ using flow cytometry and for functional progenitor cells using a CFU-GM assay. The cells were cryopreserved after testing. For our study, samples were tested simultaneously at a single facility. Each sample was individually thawed and a baseline thaw sample collected; 10 ml of the donor specimen was pushed through a syringe into a specimen container (intravenous push sample). The remainder of the specimen was infused through the IMED Gemini PC-2TX pump into a specimen container (intravenous pump sample). All samples were assayed for CD34+ cell counts and CFU-GM. Data analyses were conducted using the t- test for paired samples, with values of P < 0.05 considered significant. Results failed to demonstrate a statistically significant difference between the CD34+ or CFU-GM results of the intravenous push and intravenous pump specimens. Additionally, we failed to find a statistically significant difference when we compared the intravenous push and the intravenous pump specimens with the baseline thaw sample. The results of this study support the hypothesis that the Gemini PC-2TX infusion pump can safely deliver PSCs for the purposes of stem cell transplantation.