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2.
Bone Marrow Transplant ; 53(4): 461-473, 2018 04.
Article in English | MEDLINE | ID: mdl-29330395

ABSTRACT

Predicting mobilization failure before it starts may enable patient-tailored strategies. Although consensus criteria for predicted PM (pPM) are available, their predictive performance has never been measured on real data. We retrospectively collected and analyzed 1318 mobilization procedures performed for MM and lymphoma patients in the plerixafor era. In our sample, 180/1318 (13.7%) were PM. The score resulting from published pPM criteria had sufficient performance for predicting PM, as measured by AUC (0.67, 95%CI: 0.63-0.72). We developed a new prediction model from multivariate analysis whose score (pPM-score) resulted in better AUC (0.80, 95%CI: 0.76-0.84, p < 0001). pPM-score included as risk factors: increasing age, diagnosis of NHL, positive bone marrow biopsy or cytopenias before mobilization, previous mobilization failure, priming strategy with G-CSF alone, or without upfront plerixafor. A simplified version of pPM-score was categorized using a cut-off to maximize positive likelihood ratio (15.7, 95%CI: 9.9-24.8); specificity was 98% (95%CI: 97-98.7%), sensitivity 31.7% (95%CI: 24.9-39%); positive predictive value in our sample was 71.3% (95%CI: 60-80.8%). Simplified pPM-score can "rule in" patients at very high risk for PM before starting mobilization, allowing changes in clinical management, such as choice of alternative priming strategies, to avoid highly likely mobilization failure.


Subject(s)
Hematopoietic Stem Cell Mobilization/standards , Patient Selection , Predictive Value of Tests , Adolescent , Adult , Aged , Area Under Curve , Child , Child, Preschool , Female , Hematopoietic Stem Cell Mobilization/methods , Humans , Male , Middle Aged , Multiple Myeloma/therapy , Retrospective Studies , Risk Factors , Young Adult
3.
J Acquir Immune Defic Syndr ; 76(2): 219-224, 2017 10 01.
Article in English | MEDLINE | ID: mdl-28902679

ABSTRACT

BACKGROUND: The contribution of monocyte activation in the development of HIV-associated neurocognitive disorders is not completely understood. This study aimed to explore the predictive value of peripheral monocyte/macrophage (M/M) phenotypes on the evolution of cognitive performance in a population of virologically suppressed HIV-infected patients. SETTING: Prospective, observational, longitudinal study. METHODS: HIV-1-infected patients with HIV-RNA <50copies/mL for >12 months underwent neuropsychological examination at baseline and after 1 year. Cognitive performance was evaluated using Z-transformed scores, and neurocognitive impairment (NCI) was defined according to Frascati criteria. Peripheral M/M phenotypes (classic CD14CD16, intermediate CD14CD16, and nonclassic CD14CD16) and specific surface activation markers (eg, CD163, CD11b, and CD38) were evaluated using flow cytometry at baseline. Predictive value of peripheral M/M phenotypes on the evolution of cognitive performance over 1-year follow-up was also evaluated. RESULTS: Overall, 54 patients [85.2% men, median age 50 years (range 27-60 years), 27.8% hepatitis C virus coinfected, 48.1% with past AIDS-defining events, median nadir CD4 83 cells/µL (range 1-334), median baseline CD4 547 cells/µL (range 136-1652)] were enrolled. Proportion of patients with NCI was low, accounting for 13% at baseline and 16.5% after 1 year (P = 0.687). Memory was the only single domain in which decreased performance after 1 year was observed (-0.25 Z-score, P = 0.025). In patients with significant decrease (≥0.5 SD) in memory performance (n = 20), significantly lower CD14CD16CD163 (% CD14CD16) (P = 0.038) and higher CD14CD38 (% CD14) (P = 0.030) levels were observed. CONCLUSIONS: In virologically suppressed HIV-infected patients, the evolution of memory performance could be linked to the expression of certain peripheral activated M/M phenotypes. Such associations should be verified in larger populations over the long term.


Subject(s)
Cognition Disorders/complications , Cognition , HIV Infections/complications , Macrophages/cytology , Monocytes/cytology , Adolescent , Adult , Biomarkers/metabolism , Cognition Disorders/virology , Cross-Sectional Studies , Endpoint Determination , Evolution, Molecular , Female , Humans , Longitudinal Studies , Male , Middle Aged , Phenotype , Prospective Studies , Young Adult
4.
Biol Blood Marrow Transplant ; 23(12): 2070-2078, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28712935

ABSTRACT

Seventy-four patients who relapsed after allogeneic stem cell transplantation were enrolled in a phase IIA study and treated with the sequential infusion of donor lymphocyte infusion (DLI) followed by cytokine-induced killer (CIK) cells. Seventy-three patients were available for the intention to treat analysis. At least 1 infusion of CIK cells was given to 59 patients, whereas 43 patients received the complete cell therapy planned (58%). Overall, 12 patients (16%) developed acute graft-versus-host disease (aGVHD) of grades I to II in 7 cases and grades III to IV in 5). In 8 of 12 cases, aGVHD developed during DLI treatment, leading to interruption of the cellular program in 3 patients, whereas in the remaining 5 cases aGVHD was controlled by steroids treatment, thus allowing the subsequent planned administration of CIK cells. Chronic GVHD (cGVHD) was observed in 11 patients (15%). A complete response was observed in 19 (26%), partial response in 3 (4%), stable disease in 8 (11%), early death in 2 (3%), and disease progression in 41 (56%). At 1 and 3 years, rates of progression-free survival were 31% and 29%, whereas rates of overall survival were 51% and 40%, respectively. By multivariate analysis, the type of relapse, the presence of cGVHD, and a short (<6 months) time from allogeneic hematopoietic stem cell transplantation to relapse were the significant predictors of survival. In conclusion, a low incidence of GVHD is observed after the sequential administration of DLI and CIK cells, and disease control can be achieved mostly after a cytogenetic or molecular relapse.


Subject(s)
Cytokine-Induced Killer Cells/transplantation , Hematopoietic Stem Cell Transplantation/methods , Lymphocyte Transfusion/methods , Adolescent , Adult , Aged , Child , Child, Preschool , Female , Graft vs Host Disease/drug therapy , Graft vs Host Disease/etiology , Humans , Lymphocyte Transfusion/adverse effects , Male , Middle Aged , Prognosis , Recurrence , Remission Induction , Survival Analysis , Transplantation, Homologous , Treatment Outcome , Young Adult
7.
Transfus Apher Sci ; 54(3): 345-55, 2016 Jun.
Article in English | MEDLINE | ID: mdl-27216544

ABSTRACT

Allogeneic stem cell transplantation (allo-SCT) is considered the cornerstone in the treatment of several malignant and not malignant hematological diseases. However, relapse of hematological disease after allo-SCT is considered the most challenging point in the field. The risk can be reduced through optimal patients, donor and disease selection before allo-SCT, but harnessing donor immune system is an appealing way to treat or avoid disease relapse. Donor lymphocyte infusion (DLI) is a simple and effective therapy after allo-SCT. In this paper, the efficacy of DLI will be analyzed in different hematological diseases, focusing also on their therapeutic or pre-emptive use.


Subject(s)
Blood Donors , Donor Selection/methods , Hematologic Diseases/therapy , Hematopoietic Stem Cell Transplantation/methods , Lymphocyte Transfusion/methods , Allografts , Humans
8.
Transfus Apher Sci ; 53(3): 279-82, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26621538

ABSTRACT

Hematological diseases in pregnancy should be carefully managed with a multidisciplinary approach, which should include obstetrics, hematology and, in selected patients, apheresis professionals. Hematological malignancies in pregnant women are rare, but the attending physicians should be aware that the use of cytotoxic drugs, tyrosine-kinase inhibitors or differentiating agents such as all-trans retinoic acid (ATRA) during the first trimester of pregnancy might be teratogenic and, in turn, induce fetal abnormalities or abortion. Thus, in pregnant patients with either acute or chronic leukemia presenting with symptomatic hyperleukocytosis, leukocytapheresis (LA) could be considered as a bridge therapeutic option. Furthermore, sickle cell disease (SCD) in pregnant women is usually managed only with supportive care, i.e. packed red blood cell (RBC) transfusion to prevent excessive hemoglobin decrease, hydration and prevention of acute sickling crisis. Nevertheless, selected patients at high risk for placental detachment due to vasoocclusive acute crisis or with multiple pregnancies may benefit from prophylactic erythrocyte exchange (EEX). Both LA and EEX must be carried out by well trained personnel and the patients (and the fetus) must be under close clinical and instrumental monitoring. In the present paper, recent indications for performing either LA or EEX in pregnant patients are reviewed.


Subject(s)
Anemia, Sickle Cell/therapy , Erythrocyte Transfusion/methods , Leukapheresis/methods , Leukemia/therapy , Leukocytosis/therapy , Pregnancy Complications, Hematologic/therapy , Pregnancy Complications, Neoplastic/therapy , Acute Disease , Chronic Disease , Female , Humans , Pregnancy
11.
Interact Cardiovasc Thorac Surg ; 19(3): 523-5, 2014 Sep.
Article in English | MEDLINE | ID: mdl-24920760

ABSTRACT

In this case report, we report the application of frozen-and-thawed allogeneic platelet gel (PLT-gel) to treat a late driveline exit site infection in a 56-year old patient supported by a Heartware-HVAD left ventricular assist device. The treatment duration was 4 weeks and at the follow-up the skin around the exit site was free from further infection. PLT-gel can be used to treat local infection of the driveline exit site and to prevent further high-risk infections.


Subject(s)
Biological Dressings , Blood Platelets , Heart Failure/therapy , Heart-Assist Devices/adverse effects , Platelet-Rich Plasma , Prosthesis-Related Infections/therapy , Pseudomonas Infections/therapy , Ventricular Function, Left , Freezing , Gels , Heart Failure/diagnosis , Heart Failure/physiopathology , Humans , Male , Middle Aged , Prosthesis Design , Prosthesis-Related Infections/diagnosis , Prosthesis-Related Infections/microbiology , Pseudomonas Infections/diagnosis , Pseudomonas Infections/microbiology , Time Factors , Treatment Outcome
14.
Transfusion ; 54(9): 2353-60, 2014 Sep.
Article in English | MEDLINE | ID: mdl-24654567

ABSTRACT

BACKGROUND: Autologous stem cell transplantation (ASCT) requires collection and cryopreservation of hematopoietic progenitor cells (HPCs), which in turn may be partially or never reinfused. Thus, HPC storage has become a logistic, ethical, and economic issue. SIDEM, GITMO, and CNT/ISS endorsed a project aimed to define national criteria for HPC disposal aimed to guarantee appropriateness and equity. STUDY DESIGN AND METHODS: A multidisciplinary panel was convened including HPC harvest and manipulation experts from apheresis units, hematologists with clinical expertise in ASCT, a representative of the national health authority, and a bioethicist. An analytic hierarchy process (AHP) was carried out to select disposal criteria. RESULTS: The AHP selected two criteria for prompt disposal of freshly collected HPCs: an abnormal freezing procedure causing highly reduced viability or major microbiology contamination. Moreover, AHP selected six major criteria, each one of them allowing for the disposal of stored HPC units: patient death, withdrawal of consent to ASCT, contraindications or loss of indications to ASCT, a damaged label that prevents correct identification of the unit, and time elapsed since harvest longer than 10 years. Three minor criteria were additionally identified that allowed to anticipate disposal only provided that viability levels are below the limit of acceptance: a documented cold chain interruption, loss of bag integrity, and total amount of stored CD34+ cells lower than 1 × 10(6) /kg or lower than 2 × 10(6)/kg in patients with a successfully completed stem cell transplantation program. CONCLUSIONS: A formal consensus process allowed SIDEM and GITMO to propose a policy for autologous HPC disposal that fulfills clinical, ethical, and economic criteria.


Subject(s)
Hematopoietic Stem Cell Transplantation/legislation & jurisprudence , Hematopoietic Stem Cells/cytology , Transplantation, Autologous/legislation & jurisprudence , Humans
15.
Transfus Apher Sci ; 50(2): 200-6, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24569005

ABSTRACT

Collection of peripheral blood hematopoietic stem cells (PBSC) is the practice of choice for graft procurement in both autologous and allogeneic setting. The success of this procedure depends on the use of adequate vascular accesses. Well-sized peripheral veins are the first option in autologous and allogeneic donations. In autologous setting, in case of lack of adequate veins, central venous catheters (CVC) may be used for collection. In the allogeneic setting, although available data have shown the safety of the use of CVC, there are still some controversies about the possible insertion of a CVC in donors. A specific policy from competent registries is usually applied in the different countries to regulate the use of CVC in unrelated donors. In siblings, the question is still undefined due both to the lack of shared guidelines and to the specific characteristics of this donation. In fact, in not so rare cases, larger stem cell doses for specific cell manipulations (e.g., T/B cell depletion in the haploidentical setting) are needed. The lack of international rules or standard that forbid the use of a CVC in siblings and published data that document the safety of this procedure, allowed the Società Italiana di Emaferesi e Manipolazione Cellulare (SIdEM) national Board to identify a possible, shared, operational approach to address this issue by a case-specific risk-benefit assessment.


Subject(s)
Central Venous Catheters , Peripheral Blood Stem Cell Transplantation/methods , Peripheral Blood Stem Cell Transplantation/standards , Siblings , Allografts , Female , Humans , Italy , Male , Practice Guidelines as Topic
16.
Cytotherapy ; 16(1): 101-10, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24169075

ABSTRACT

BACKGROUND AIMS: Hematopoietic stem cell cryopreservation significantly contributed to autologous stem cell transplantation (ASCT). Cryopreserved stem cell units (SCU) are expected to be used soon after harvesting for most purposes, but, in a number of cases, they remain stored for some time, creating an increasing load for SCU depositories. Disposal policies vary widely in each center, and the existing guidelines are insufficient. METHODS: We conducted a survey of seven Gruppo Italiano Trapianto di Midollo Osseo centers to investigate the outcome of SCU harvested from January 2005 to December 2009 for ASCT. The data from 1603 collections were gathered, for a total of 5822 SCU. RESULTS: In our cohort, 79% of patients collected >5 × 106 CD34+ cells/kg, and 3.4% collected <2 × 106 CD34+ cells/kg. Up to 21% of all the patients and 42% of those with acute leukemia did not undergo reinfusion, and 37% of the cryopreserved SCU were excess, resulting from patients not reinfusing or partially reinfusing. Less than one-third of the excess SCU was disposed, and the major causes of disposal were death and, in a minority of cases, withdrawal of the indication for ASCT. In our analysis, very few first reinfusions occurred after 2 years, and those after 5 years were exceptional. Through the use of a multivariate analysis, we sought to identify the risk factors for collection non-use, independent of the centers' policies. Non-use of SCU was significantly associated with patients with acute leukemia, collections of <2 × 106 CD34/kg and lower age groups. CONCLUSIONS: These data serve as a valid basis to support rational recommendations for cost-effective storage and disposal of SCU.


Subject(s)
Cryopreservation , Hematopoietic Stem Cells/cytology , Stem Cell Transplantation/methods , Autografts/cytology , Autografts/metabolism , Cell- and Tissue-Based Therapy , Hematopoietic Stem Cells/metabolism , Humans
17.
Biol Blood Marrow Transplant ; 20(3): 375-81, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24321746

ABSTRACT

This phase I multicenter study was aimed at assessing the feasibility and safety of intravenous administration of third party bone marrow-derived mesenchymal stromal cells (MSC) expanded in platelet lysate in 40 patients (15 children and 25 adults), experiencing steroid-resistant grade II to IV graft-versus-host disease (GVHD). Patients received a median of 3 MSC infusions after having failed conventional immunosuppressive therapy. A median cell dose of 1.5 × 10(6)/kg per infusion was administered. No acute toxicity was reported. Overall, 86 adverse events and serious adverse events were reported in the study, most of which (72.1%) were of infectious nature. Overall response rate, measured at 28 days after the last MSC injection, was 67.5%, with 27.5% complete response. The latter was significantly more frequent in patients exhibiting grade II GVHD as compared with higher grades (61.5% versus 11.1%, P = .002) and was borderline significant in children as compared with adults (46.7 versus 16.0%, P = .065). Overall survival at 1 and 2 years from the first MSC administration was 50.0% and 38.6%, with a median survival time of 1.1 years. In conclusion, MSC can be safely administered on top of conventional immunosuppression for steroid resistant GVHD treatment. Eudract Number 2008-007869-23, NCT01764100.


Subject(s)
Antineoplastic Agents/therapeutic use , Graft vs Host Disease/therapy , Hematologic Neoplasms/therapy , Mesenchymal Stem Cell Transplantation , Adolescent , Adult , Aged , Child , Child, Preschool , Drug Resistance, Neoplasm , Female , Graft vs Host Disease/immunology , Graft vs Host Disease/mortality , Graft vs Host Disease/pathology , Hematologic Neoplasms/immunology , Hematologic Neoplasms/mortality , Hematologic Neoplasms/pathology , Humans , Immunosuppressive Agents/therapeutic use , Infant , Male , Middle Aged , Remission Induction , Severity of Illness Index , Steroids/therapeutic use , Survival Analysis , Transplantation, Homologous
18.
J Clin Apher ; 28(6): 411-5, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24000045

ABSTRACT

Erythrocyte-exchange (EEX) has proven to be a very useful tool in sickle-cell disease (SCD) patients either during acute painful crisis unresponsive to hydration and/or analgesia or as a prophylactic treatment in high risk patients in those who do not tolerate hydroxyurea (HU), with the aim of lowering HbS levels. EEX may be performed either by using continuous- or discontinuous flow devices, the former being of choice in children or in low-weight patients. Thus, a low extracorporeal blood volume (EBV) could allow for a better and safer procedure management. In this study we compared EEX procedure performed with the recently released OPTIA device with EEX procedures performed using the COBE Spectra device (EBV 185 vs 270 mL, respectively). Twenty-one EEX (4 as emergency treatment) were performed in 12 patients with the Spectra device and 25 (9 as emergency treatment) in 15 patients with the OPTIA device. All the procedures were well tolerated and uneventful. We did not observe significant differences between the two devices as to pre- and post-EEX parameters, namely in target hematocrit and in HbS reduction. Noteworthy, due to the lowest EBV allowed by the OPTIA device, an EEX procedure performed in a 13 Kg- child did not require a preliminary priming of the circuit. In conclusion, the OPTIA device proved to be as effective as the Spectra device in treating SCD patients either during sickling crisis or as prophylactic therapy. The OPTIA device can be safely used in the pediatric setting since it allows a lower EBV.


Subject(s)
Anemia, Sickle Cell/therapy , Cytapheresis/instrumentation , Erythrocyte Transfusion/methods , Flow Cytometry/methods , Adult , Anemia, Sickle Cell/blood , Blood Cell Count , Blood Volume , Body Weight , Cytapheresis/methods , Emergencies , Equipment Design , Female , Humans , Male , Young Adult
20.
Hematol Rep ; 5(2): 36-8, 2013 Jun 28.
Article in English | MEDLINE | ID: mdl-23888247

ABSTRACT

We report on a case of delayed hemolytic transfusion reaction (DHTR) occurred 7 days after an erythrocytapheresis or eritroexchange procedure (EEX) treated with rituximab and glucocorticoids in a 15-years old patient with sickle cell disease. EEX was performed despite a previous diagnosis of alloimmunization, in order to reduce hemoglobin S rate before a major surgery for avascular necrosis of the femoral head. A first dose of rituximab was administered before EEX. However, rituximab couldn't prevent DHTR that occurred with acute hemolysis, hemoglobinuria and hyperbilirubinemia. A further dose of rituximab and three boli of methylprednisolone were given after the onset of the reaction. It is likely that the combined use of rituximab and steroids managed to gradually improve both patient's general conditions and hemoglobin levels. Nor early or late side effects were registered in a 33-months follow-up period. This report suggests the potential effectiveness and safety of rituximab in combination with steroids in managing and mitigating the symptoms of delayed post-transfusional hemolytic reactions in alloimmunized patients affected by sickle cell disease with absolute need for erythrocytapheresis.

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