A randomized controlled clinical trial to determine the optimum duration of G-CSF priming prior to BM stem cell harvesting

Abstract

Background

Harvesting of hemopoietic stem cells (HSC) from G-CSF-primed BM for autologous transplantation is an alternative to collection of unprimed BM or G-CSF-primed peripheral blood (PB). However, the optimum number of days of G-CSF administration for this purpose is unknown. We set out to determine whether cell yields could be optimized by varying the number of days of G-CSF administration prior to BM stem cell harvesting.

Methods

We conducted a randomized controlled single-center trial of 6 days (the standard) vs. 4 days of G-CSF administration and compared yields of total nucleated cells (TNC), CD34⁺ HSC and CFU-GM cells per kilogram patient body weight. Statistical analysis was by Student's t-test.

Results

Twenty-four patients were enrolled; 13 received 6 days and 11 received 4 days of G-CSF administration. Analysis of the first harvest aspirate showed higher proportions of CD34⁺ HSC (P=0.02) and CFU-GM (P=0.03) in the 4-day group. For the 6-day and 4-day groups, respectively, the median yield of TNC/kg was 6.5×10⁸ and 5.4×10⁸ (P=0.28), of CD34⁺ cells/kg 0.56×10⁶ and 0.98×10⁶ (P=0.04) and of CFU-GM cells/kg 1.66×10⁵ and 1.55×10⁵ (P=0.75).

Discussion

These results suggest that by 6 days the HSC-stimulating effect of G-CSF has passed its peak and that 4 days should be adopted as the standard for G-CSF priming prior to BM stem cell harvesting for autologous transplantation.

• autologous
• BMT
• G-CSF
• harvesting
• yields