title: A randomized phase III clinical trial of autologous blood stem cell transplantation comparing cryopreservation using dimethylsulfoxide vs dimethylsulfoxide with hydroxyethylstarch.
abstract: 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 >or=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 >or=0.5 x 10(9) and >or=1.0 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 >or=20 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.
authors.affiliation: Clinical Research Division, Fred Hutchinson Cancer Research Center Seattle, WA, USA.
authors.forename: S D
authors.initials: SD
authors.lastname: Rowley
authors.forename: Z
authors.initials: Z
authors.lastname: Feng
authors.forename: L
authors.initials: L
authors.lastname: Chen
authors.forename: L
authors.initials: L
authors.lastname: Holmberg
authors.forename: S
authors.initials: S
authors.lastname: Heimfeld
authors.forename: B
authors.initials: B
authors.lastname: MacLeod
authors.forename: W I
authors.initials: WI
authors.lastname: Bensinger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001781:Blood Component Removal / Q000379:methods; D002648:Child; D002675:Child, Preschool; D015925:Cryopreservation / Q000379:methods*; D003451:Cryoprotective Agents / Q000494:pharmacology; D004121:Dimethyl Sulfoxide; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000494:pharmacology*; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000145:classification / Q000628:therapy*; D010952:Plasma Substitutes / Q000494:pharmacology*; D010976:Platelet Count; D014182:Transplantation, Autologous / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D003451:Cryoprotective Agents; D006895:Hydroxyethyl Starch Derivatives; D010952:Plasma Substitutes; D004121:Dimethyl Sulfoxide