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

• Published in: Cytotherapy (Oxford, England) England), 2007, Vol.9 (2), p.158-164
• Main Authors: Lowenthal, Rm, Ragg, Sj, Anderson, J, Nicholson, L, Harrup, Ra, Tuck, D
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Advanced Basic Science; Aged; Antigens, CD34 - metabolism; autologous; BMT; Bone Marrow Transplantation - methods; Cell Separation - methods; Female; G-CSF; Granulocyte Colony-Stimulating Factor - administration & dosage; Granulocyte Colony-Stimulating Factor - pharmacology; harvesting; Hematopoietic Stem Cells - cytology; Hematopoietic Stem Cells - drug effects; Hematopoietic Stem Cells - immunology; Humans; Male; Middle Aged; Other; Time Factors; Transplantation, Autologous; yields
• ISSN: 1465-3249; 1477-2566
• DOI: 10.1080/14653240601182820

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.