Mobilization of hematopoietic progenitor stem cells in allogeneic setting with lenograstim by subcutaneous injection, in daily or twice-daily dosing: a single-center prospective study with historical control.

BACKGROUND: Although the mobilization of hematopoietic progenitor stem cells from healthy donors (HDs) using granulocyte-colony-stimulating factor is widely used, the ideal method for the administration of the cytokine has not yet been determined. STUDY DESIGN AND METHODS: Seventy-five consecutive HDs received lenograstim (LENO) as mobilization agent. LENO was given subcutaneously at a dose of 10 µg/kg in a once-daily dose (ODD) every 24 hours. Results were compared with a historical control group of 181 HDs treated with 5 µg/kg LENO twice-daily dose (TDD) with a time interval of 12 hours. RESULTS: CD34+ cell concentrations evaluated on Day 4 and on Day 5 were 45 × 10(6) (range, 6 × 10(6) -217 × 10(6) )/L and 75 × 10(6) (range, 7 × 10(6) -279 × 10(6) )/L with ODD versus 36 × 10(6) (range, 3 × 10(6) -200 × 10(6) )/L and 55 × 10(6) (range, 3 × 10(6) -738 × 10(6) )/L with TDD (p = 0.067 and p = 0.001). The collected CD34+ cell counts in first apheresis procedure were 5.6 × 10(6) ± 2.9 × 10(6) and 5.7 × 10(6) ± 3 × 10(6) /kg donor and recipient body weight in the ODD versus 5.4 × 10(6) ± 3.8 × 10(6) and 5.3 × 10(6) ± 3.5 × 10(6) /kg in the TDD cohort, respectively (p = 0.08 and p = 0.02). Five HDs (6.7%) mobilized CD34+ cells of fewer than 2 × 10(6) /kg recipient body weight in the ODD group compared with seven HDs (3.9%) in the TDD group (p = 0.3). CONCLUSIONS: Once-daily administration of LENO is at least as effective as twice-daily administration for the mobilization of CD34+ cells in HDs.

High incidence of factor V Leiden and prothrombin G20210A in healthy southern Italians.

Factor V Leiden (FVL) and G20210 prothrombin (FII G20210A) mutations are risk factors for thromboembolism. In Europe, FVL is more prevalent in the north (7%) than in the south (3%), whereas FII G20210A is more common in the south (3% to 7%) than in the north (2% to 5%). In Italy, the prevalence is 2% to 3% for both. The aim of this study was to assess if these polymorphisms could be more frequent in the south than in the rest of Italy. In 105 blood donors in southern Italy, the prevalence of FVL and FIIG20210A was 9.5% and 5.7%, respectively. These prevalence data are higher when compared with published data. The results of this study are as high as those observed in Greece and the Middle East. The diffusion of FVL and FII G20210A in the Mediterranean, consequent to Phoenician and Greek colonization, could be a reason for the high prevalence observed.

Indications and organisational methods for autologous blood transfusion procedures in Italy: results of a national survey.

INTRODUCTION: Pre-operative donation of autologous blood is a practice that is now being abandoned. Alternative methods of transfusing autologous blood, other than predeposited blood, do however play a role in limiting the need for transfusion of allogeneic blood. This survey of autologous blood transfusion practices, promoted by the Italian Society of Transfusion Medicine and Immunohaematology more than 2 years after the publication of national recommendations on the subject, was intended to acquire information on the indications for predeposit in Italy and on some organisational aspects of the alternative techniques of autotransfusion. MATERIALS AND METHODS: A structured questionnaire consisting of 22 questions on the indications and organisational methods of autologous blood transfusion was made available on a web platform from 15 January to 15 March, 2013. The 232 Transfusion Services in Italy were invited by e-mail to complete the online survey. RESULTS: Of the 232 transfusion structures contacted, 160 (69%) responded to the survey, with the response rate decreasing from the North towards the South and the Islands. The use of predeposit has decreased considerably in Italy and about 50% of the units collected are discarded because of lack of use. Alternative techniques (acute isovolaemic haemodilution and peri-operative blood salvage) are used at different frequencies across the country. DISCUSSION: The data collected in this survey can be considered representative of national practice; they show that the already very limited indications for predeposit autologous blood transfusion must be adhered to even more scrupulously, also to avoid the notable waste of resources due to unused units.Users of alternative autotransfusion techniques must be involved in order to gain a full picture of the degree of use of such techniques; multidisciplinary agreement on the indications for their use is essential in order for these indications to have an effective role in "patient blood management" programmes.

Harvesting peripheral blood progenitor cells from healthy donors: retrospective comparison of filgrastim and lenograstim.

Mobilization of CD34+ into peripheral blood is attained by either glycosylated (lenograstim) or non-glycosylated recombinant G-CSF (filgrastim). 101 donors, 57 males, median age 42 years (range 16-63) entered this retrospective study. Group I (55 cases) received filgrastim and group II lenograstim subcutaneously for 5-6 days. The peak number of CD34+ cells/microl blood observed on day 4 and 5 was not significantly different in the two groups. No differences were shown in terms of both circulating CFU-GM at the time of harvesting and CD34+ target of collection. The most frequent side effects were bone pain (18.2% grade I; 36.4% grade II, 7.3% grade III), headache (18.2%), nausea (9.1%), fever (5.5%) and a mild splenomegaly (> 2 cm) (5.5%) in filgrastim group, and bone pain (37.0% grade I, 26.1% grade II, 2.2% grade III), headache (17.4%), nausea (15.2%), fever (4.4%) and a mild splenomegaly (4.3%) in lenograstim group, respectively. CD34+ collection was associated with thrombocytopenia, which was not significantly different between the two groups. No donor in either group developed long-term adverse effects. We conclude that both G-CSFs are comparable in terms of CD34+ cell collection, safety and tolerability.