scholarly journals A Randomized Controlled Trial to Compare Once- versus Twice-Daily Filgrastim for Mobilization of Peripheral Blood Stem Cells from Healthy Donors

2006 ◽  
Vol 12 (4) ◽  
pp. 408-413 ◽  
Author(s):  
Yukiko Komeno ◽  
Yoshinobu Kanda ◽  
Tamae Hamaki ◽  
Kinuko Mitani ◽  
Kimiko Iijima ◽  
...  
Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2148-2148
Author(s):  
Vladan Vucinic ◽  
Nadezda Basara ◽  
Runa Stiegler ◽  
Kristina Bartsch ◽  
Constanze Kliem ◽  
...  

Abstract Abstract 2148 Poster Board II-125 Introduction: The standard procedure for obtaining peripheral blood stem cells (PBSC) is donor mobilization with G-CSF. Pegfilgrastim is a covalently bound conjugate of filgrastim and monomethoxypolyethylene glycol with longer half-life elimination due to decreased plasma clearance and could represent an alternative approach for PBSC mobilization in healthy donors. Design and Methods: From July 2006 till August 2009 28 related healthy donors (50% male, 50% female) were treated with single dose of 12 mg pegfilgrastim for mobilization of allogeneic PBSC. The harvests were performed as large-volume, continuous-flow collections using a Cobe Spectra blood cell separator on day 4 and if necessary on day 5 of the mobilization regimen. In case of inadequate CD34+ counts (less than 4×106/kg body weight of recipient on day 5), stimulation was continued with filgrastim. In addition, the serum level of filgrastim was determined twice daily. Results: We present the results of 27 donors (the results of the 28th donor are still pending). In all 27 cases the harvests were successful. In 22 out of 27 donors (82%) only a single apheresis was needed to reach the target. Two of the donors required additional treatment with non-pegylated filgrastim. The maximal concentration of circulating CD34+ cells was achieved on day 4 (median 74.3/μl; range 24.6-136.6). The median yield of CD34+ cells was 5.9×106/kg of the recipients body weight (range 3-14.5), and the median CD3+ count was 9.1×108/kg of the recipient body weight (range 1.4-6.2). Serum filgrastim level peak was on day 2 of the mobilization regimen with a median level of 226 ng/ml (range 35 to 1123 ng/ml), thus preceding the increase of CD34+ cells in blood. The main adverse events were WHO grade 1 and included headaches, bone pain and transient elevations of alkaline phosphatase and lactate dehydrogenase. Conclusion: PBSC mobilization with a single dose of pegfilgrastim is feasible for healthy donors. The graft composition was comparable to that obtained with the conventional regimen of short-term G-CSF. Long-term follow-up of healthy donors treated with pegfilgrastim should be further investigated. Disclosures: No relevant conflicts of interest to declare.


2002 ◽  
Vol 6 (6) ◽  
pp. 413-418 ◽  
Author(s):  
N. Shimizu ◽  
T. Asai ◽  
S. Hashimoto ◽  
M. Narita ◽  
M. Kobayashi ◽  
...  

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Thana Turajane ◽  
Ukrit Chaveewanakorn ◽  
Warachaya Fongsarun ◽  
Jongjate Aojanepong ◽  
Konstantinos I. Papadopoulos

In this randomized controlled trial, in early osteoarthritis (OA) that failed conservative intervention, the need for total knee arthroplasty (TKA) and WOMAC scores were evaluated, following a combination of arthroscopic microdrilling mesenchymal cell stimulation (MCS) and repeated intra-articular (IA) autologous activated peripheral blood stem cells (AAPBSCs) with growth factor addition (GFA) and hyaluronic acid (HA) versus IA-HA alone. Leukapheresis-harvested AAPBSCs were administered as three weekly IA injections combined with HA and GFA (platelet-rich plasma [PRP] and granulocyte colony-stimulating factor [hG-CSF]) and MCS in group 1 and in group 2 but without hG-CSF while group 3 received IA-HA alone. Each group of 20 patients was evaluated at baseline and at 1, 6, and, 12 months. At 12 months, all patients in the AAPBSC groups were surgical intervention free compared to three patients needing TKA in group 3 (p<0.033). Total WOMAC scores showed statistically significant improvements at 6 and 12 months for the AAPBSC groups versus controls. There were no notable adverse events. We have shown avoidance of TKA in the AAPBSC groups at 12 months and potent, early, and sustained symptom alleviation through GFA versus HA alone. Differential effects of hG-CSF were noted with an earlier onset of symptom alleviation throughout.


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