A randomized phase III clinical trial of autologous blood stem cell transplantation comparing cryopreservation using dimethylsulfoxide vs dimethylsulfoxide with hydroxyethylstarch

Hematopoietic stem cells intended for autologous transplantation are usually cryopreserved in solutions containing 10% dimethylsulfoxide ( DMSO, v/v) or 5% DMSO in combination with 6% hydroxyethylstarch (HES, w/v). We performed a single-blinded, randomized study comparing these cryoprotectant solutions for patients undergoing autologous peripheral blood stem cell (PBSC) transplantation. A total of 294 patients were evaluable; 148 received cells frozen with 10% DMSO and 146 received cells frozen in 5% DMSO/6% HES. Patients who received cells frozen with the combination cryoprotectant recovered their white blood cell count greater than or equal to 1.0 x 10(9)/l at a median of 10 days, one day faster than those who received PBSC frozen with DMSO alone ( P = 0.04). Time to achieve neutrophil counts of greater than or equal to0.5 x 10(9) and greater than or equal to1.0 x 10(9)/l were similarly faster for the recipients of the cells frozen in the combination solution. This effect was more pronounced for patients who received quantities of CD34+ cells higher than the median for the population. Median time to discontinuation of antibiotic use was also one day faster for the recipients of cells cryopreserved with DMSO/HES ( P = 0.04). In contrast, median times to recovery of platelet count greater than or equal to20 x 10(9)/l were equivalent for each group (10 days; P = 0.99) and the median numbers of red cell and platelet transfusions did not differ.