title: A prospective study of G-CSF primed bone marrow as a stem-cell source for allogeneic bone marrow transplantation in children: a Pediatric Blood and Marrow Transplant Consortium (PBMTC) study.
abstract: A prospective multicenter trial was conducted to evaluate the safety and feasibility of granulocyte colony-stimulating factor (G-CSF)-primed bone marrow (G-BM) in children receiving allogeneic bone marrow transplantation (BMT). A total of 42 children with a median age of 9.8 years (range, 0.8-17 years) were enrolled. Donors with median age of 9.2 years (range, 1.1-22 years) received 5 microg/kg per day of subcutaneous G-CSF for 5 consecutive days. BM was harvested on the fifth day. No donor experienced complications related to G-CSF administration or marrow har-vest. Median nucleated (NC) and CD34 cells infused was 6.7 x 10(8)/kg (range, 2.4-18.5 x 10(8)/kg) and 7.4 x 10(6)/kg (range, 2-27.6 x 10(6)/kg), respectively. Neutrophil and platelet engraftment was at a median of 19 days (range, 13-28 days) and 20 days (range, 9-44 days), respectively. A total of 13 (32%) patients developed grade 2 graft-versus-host disease (GVHD), and 5 (13%) of 40 evaluable patients developed chronic GVHD (3 limited and 2 extensive). Higher cell dose was not associated with increased risk of acute or chronic GVHD. Overall survival and event-free survival at 2 years were 81% and 69%, respectively. Collection of G-BM from pediatric donors is safe, and can result in high NC and CD34 cell doses that facilitate engraftment after myeloablative BMT without a discernable increase in the risk of GVHD.
authors.affiliation: Department of Pediatrics, Vanderbilt University, Nashville, TN 37232-2573, USA. haydar.frangoul@vanderbilt.edu
authors.forename: Haydar
authors.initials: H
authors.lastname: Frangoul
authors.forename: Eneida R
authors.initials: ER
authors.lastname: Nemecek
authors.forename: Dean
authors.initials: D
authors.lastname: Billheimer
authors.forename: Michael A
authors.initials: MA
authors.lastname: Pulsipher
authors.forename: Shakila
authors.initials: S
authors.lastname: Khan
authors.forename: Ann
authors.initials: A
authors.lastname: Woolfrey
authors.forename: Becky
authors.initials: B
authors.lastname: Manes
authors.forename: Catherine
authors.initials: C
authors.lastname: Cole
authors.forename: Mark C
authors.initials: MC
authors.lastname: Walters
authors.forename: Mouhab
authors.initials: M
authors.lastname: Ayas
authors.forename: Yaddanapudi
authors.initials: Y
authors.lastname: Ravindranath
authors.forename: John E
authors.initials: JE
authors.lastname: Levine
authors.forename: Stephan A
authors.initials: SA
authors.lastname: Grupp
mesh_terms: D000293:Adolescent; D000328:Adult; D018952:Antigens, CD34; D001853:Bone Marrow / Q000187:drug effects*; D016026:Bone Marrow Transplantation / Q000379:methods* / Q000401:mortality; D002452:Cell Count; D002648:Child; D002675:Child, Preschool; D006085:Graft Survival; D006086:Graft vs Host Disease; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000633:toxicity; D006412:Hematopoietic Stem Cells / Q000187:drug effects*; D006801:Humans; D007223:Infant; D007700:Kinetics; D011446:Prospective Studies; D016019:Survival Analysis; D014184:Transplantation, Homologous