title: A phase II trial evaluating the safety and effectiveness of the AastromReplicell system for augmentation of low-dose blood stem cell transplantation.
abstract: To reduce the number of apheresis procedures and maintain the usual rate of hematopoietic recovery in patients treated with high-dose chemotherapy, we studied the effect of adding a small volume of ex vivo expanded bone marrow to low doses of CD34(+) blood stem cells. Thirty-four patients with breast cancer received G-CSF (10 microg/kg/day) priming followed by a limited volume (50-100 ml) bone marrow aspiration and standard 10-liter aphereses. Marrow was expanded ex vivo using the AastromReplicell system and infused along with low doses of blood-derived CD34(+) cells, collected in one apheresis. Thirty-one evaluable patients received a median CD34(+) blood stem cell dose of 0.7 x 10(6)/kg (range, 0.2-2.5) and 4.7 x 10(7) nucleated cells/kg (range, 1.98-8.7) of ex vivo expanded marrow. All patients recovered with normal blood counts and engrafted 500 neutrophils/microl and 20 000 platelets/microl in a median of 10 and 13 days, respectively. Multivariate analysis revealed that, in addition to CD34(+) lineage negative cell quantity, the quantity of stromal progenitors contained in the ex vivo expanded product correlated with engraftment outcome (r = 0.551, P = 0.004). Our results indicate that ex vivo expanded bone marrow is capable of facilitating engraftment when combined with low doses of mobilized blood derived CD34(+) cells.
authors.affiliation: Department of Medicine, Hackensack University Medical Center, Hackensack, NJ, USA.
authors.forename: A L
authors.initials: AL
authors.lastname: Pecora
authors.forename: P
authors.initials: P
authors.lastname: Stiff
authors.forename: C F
authors.initials: CF
authors.lastname: LeMaistre
authors.forename: R
authors.initials: R
authors.lastname: Bayer
authors.forename: C
authors.initials: C
authors.lastname: Bachier
authors.forename: S L
authors.initials: SL
authors.lastname: Goldberg
authors.forename: M
authors.initials: M
authors.lastname: Parthasarathy
authors.forename: A A
authors.initials: AA
authors.lastname: Jennis
authors.forename: A K
authors.initials: AK
authors.lastname: Smith
authors.forename: J
authors.initials: J
authors.lastname: Douville
authors.forename: B
authors.initials: B
authors.lastname: Chen
authors.forename: R D
authors.initials: RD
authors.lastname: Armstrong
authors.forename: R K
authors.initials: RK
authors.lastname: Mandalam
authors.forename: R
authors.initials: R
authors.lastname: Preti
mesh_terms: D000328:Adult; D018952:Antigens, CD34 / Q000032:analysis; D001854:Bone Marrow Cells / Q000166:cytology; D016026:Bone Marrow Transplantation / Q000379:methods / Q000592:standards; D001943:Breast Neoplasms / Q000628:therapy; D018929:Cell Culture Techniques / Q000295:instrumentation / Q000379:methods; D016238:Cytapheresis / Q000379:methods / Q000592:standards; D004869:Equipment Safety / Q000379:methods / Q000592:standards; D005260:Female; D006085:Graft Survival; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods* / Q000592:standards; D006801:Humans; D008875:Middle Aged; D015999:Multivariate Analysis; D017154:Stromal Cells / Q000166:cytology / Q000637:transplantation; D016896:Treatment Outcome
chemical_list: D018952:Antigens, CD34