A single centre, randomised trial on harvest cell yield and marrow engraftment using haemopoietic growth-factor primed bone marrow

Abstract

The use of haemopoietic growth factors (HGFs) in the BMT setting is most often administered to recipients during the post-BMT period to enhance neutrophil recovery. However, there is little or no effect on platelet recovery when HGFs are administered in this fashion. The aim of this study is to compare HGFs primed and unprimed marrow in terms of: the haemopoietic stem and progenitor cell yields; the neutrophil and platelet engraftment in allogeneic BMT; and the incidence and severity of GVHD as well as other complications in allogeneic BMT. Methods: Thirteen patient-donor pairs were randomized to the G-CSF group, eleven pairs to the GM-CSF group and thirteen pairs to the control group. The donors randomized to group I received 10μg/kg per day G-CSF subcutaneously for four days before the bone marrow was harvested. The donors randomized to group II received 10μg/kg per day GM-CSF subcutaneous injection for four days before the bone marrow was harvested. The donors randomized to the control arm did not receive any growth factors before the bone marrow was harvested. Results: The median total nucleated cell count was slightly higher in primed BM graft. For the G-CSF primed BM, 5.77 x 108/kg, and for the GM-CSF primed BM 3.18 x 108/kg compared to 2.23 x 108/kg for the unprimed BM graft (Kruskal Wallis test, P < 0.001). The central tendency was significantly different (Kruskal Wallis Test, P < 0.003) between the three groups for the CFU-GM/kg measure. The median was 17.44 x 104/kg in the G-CSF group, 6.14 x 104/kg in the GM-CSF group and 10.12 x 104/kg in the control group. The mean time to obtain an ANC value above 1.0 x 109/L was statistically significant among the three groups (ANOVA, P < 0.046); the mean duration for group I, II and III was 23 days, 30 days and 29 days, respectively. We found that G-CSF primed BM had significantly faster engraftment of ANC > 1.0 x 109/L, compared to GM-CSF primed BM and unprimed BM. Besides, the units of RBC used post BMT were significantly less than the other two groups. G-CSF priming increased total nucleated cells and proliferation of CFU-GM in the marrow graft.