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Biomedical subjects

M Valbonesi

Publications and source records attributed to M Valbonesi.

At least 55 records · Page 3Linked to original sources
PubMed1997

Mobilization and transplantation of Philadelphia-negative peripheral-blood progenitor cells early in chronic myelogenous leukemia.

PURPOSE: Mobilization of Philadelphia (Ph) chromosome-negative progenitors is now possible in many Ph1-positive chronic myelogenous leukemia (CML) patients who had received interferon alfa (IFN-alpha) with no cytogenetic response. In this pilot study, we used this approach in patients without prior IFN-alpha therapy to determine if the number and quality of mobilized progenitors would be increased and to evaluate the potential effect of these cells as autografts. PATIENTS AND METHODS: Twenty-two untreated patients were mobilized within 12 months of diagnosis. The treatment regimen consisted of the mini-ICE protocol. Beginning on day +8, granulocyte colony-stimulating factor (G-CSF) was used in all patients. Leukophoresis was performed as the patients were recovering from aplasia, when WBC count exceeded 0.8 x 10(9)/L. RESULTS: In 14 patients, (63%) the leukophoresis product was entirely Ph1-negative and in four patients the Ph1-positive cell rate was < or = 7%. Significant numbers of long-term culture-initiating cells (LTC-IC) and CD34+ Thy1+Lin- cells were found in most of the Ph1-negative collections that were tested. Twelve patients underwent autografting with their mobilized peripheral-blood progenitor cells (PBPC) (Ph1-negative collections, 10 patients; major cytogenetic response, two patients). All patients engrafted and are alive; six have Ph1-negative marrow 7 to 15 months after autografting. Posttransplant treatment was IFN-alpha combined with interleukin (IL)-2 because of the recent demonstration of synergistic activity in augmenting cytolytic activity. CONCLUSION: Intensive chemotherapy given in early chronic phase of CML is well tolerated and results in high numbers of circulating Ph1-negative precursor cells.

Adult↗
PubMed1997

Erythrothrombocytapheresis and plasmathrombocytapheresis with storage in T-sol of platelets collected by the new Amicus cell separator.

The Amicus cell separator is the latest apparatus introduced into the international market for high-yield, low WBC contamination and short-procedure time thrombocytapheresis. In its original configuration the apparatus collects platelets for subsequent resuspension in plasma and no collection of PRBC can be carried out along with thrombocytapheresis. In this paper we present the results of plasma-thrombocytapheresis and erythro-thrombocytapheresis after the adaptation of the Amicus to the collection and storage of platelets in a non-plasma medium and the concurrent collection of PRBC. From our study it is concluded that PRBC collection doesn't modify the quality of the platelet product obtained from random donors (platelets pre-count 263x10e3/microliter) in terms of yield which is 4.6x10e11 platelets, WBC contamination (1.3x10e5) or procedure time (63 +/- 26 min.). The quality of the platelet products is satisfactory too, as measured by aggregation induced by collagen and ristocetin or by the substantial stability of membrane glycoproteins (CD62-63-51-36-42B). The concentrate had an average content of 58.8 g of hemoglobin per bag, a final volume of 376 +/- 13 ml, (after the addition of 100 ml of SAG-M) and a normal mechanic and osmotic fragility.

Blood Component Removal↗
PubMed1996

Thiotepa cyclophosphamide followed by granulocyte colony-stimulating factor mobilized allogeneic peripheral blood cells in adults with advanced leukemia.

Thirty-one patients (median age, 44 years) with advanced hematologic malignancies were given thiotepa 15 mg/kg, and cyclophosphamide 120 (n = 14) or 150 (n = 17) mg/kg followed by unfractionated peripheral blood stem cell transplants (PBSCT) from genotypically identical siblings (n = 28) or one antigen mismatched family donor (n = 3). Donors were mobilized with granulocyte colony-stimulating factor 5 to 10 microgram/kg/d for 6 days and underwent two to three leukapheresis on days +5, +6, +7. The median cell yield per donor expressed/kg of recipients body weight was as follows: nucleated cells 13 x 10(8)/kg; CD34+ cells 6 x 10(6)/kg; colony-forming unit-granulocyte macrophage 38 x 10(4)/kg, and CD3+ cells 449 x 10(6)/kg. The diagnoses were chronic myeloid leukemia (n = 4), acute myeloid (n = 9) or lymphoid leukemia (n = 2), acute myelofibrosis (n = 2), multiple myeloma (n = 1), lymphoma (n = 6), chronic lymphocytic leukemia (n = 1) myelodysplasia (n = 6). Twenty-eight patients had advanced disease, 29 patients were first grafts, and 2 were second transplants 3 and 9 years after the first. Neutrophil counts of 0.5 x 10(9)/L and platelet counts of 30 x 10(9)/L platelets were both achieved on day +14 (median). Engraftment could be proven by sex markers or DNA polymorphism in 29 of 31 patients: one had early leukemia relapse and one patient was unevaluable because of early death. Acute graft-versus-host disease (GVHD) was scored as minimal or absent (grade 0 to 1) in 14 patients, moderate (grade II) in 13, and severe (grade III to IV) in four. Causes of death were leukemia (n = 4), acute GVHD (n = 4, with associated cytomegalovirus infections in three), sepsis (n = 1), liver failure (n = 1), multiorgan failure (n = 1), and hemorrhage (n = 1). The actuarial transplant mortality is 29%, the actuarial relapse rate 22%. Nineteen patients survive with a median follow up of 288 days (100-690). The actuarial 2-year survival is 57%. Three patients received PBSCT from family donors mismatched for one class II antigen: all engrafted, one developed grade I aGVHD; one died of leukemia on day +155; two are alive disease free 267 to 290 days postgraft. This study suggests that thiotepa cyclophosphamide followed by unfractionated PBSC allograft may be an alternative form of transplant for adults with advanced leukemia, also in the setting of one antigen mismatched donor. The engraftment is rapid with acceptable GVHD and relatively low transplant-related mortality.

Actuarial Analysis↗
PubMed1996

PBSC collection from G-CSF primed donors.

Peripheral blood stems cells (PBSCs) have been used in autologous transplantation as an alternative to bone marrow-derived cells. Recently, PBSCs have been collected from healthy donors after priming with G-CSF and used for allogeneic transplantation. We have a comparatively large experience with PBSC collection in autologous and allogeneic settings. The five cell separators we employ are: the CS3000 plus, AS 104, Excel, Cobe Spectra and MCS 3p. These machines appear to have different efficacies but no studies have been carried out on this topic. In a prospective study we have randomly assigned donors to different cell separators to evaluate their efficiency. Twenty-five donors underwent the procedure and 50 leukaphereses were carried out. Donors were given 5 micrograms kg-1 d-1 of recombinant human G-CSF for 3 days and 10 micrograms kg-1 d-1 for 4 days subcutaneously. Leukaphereses were performed on days 6 and 7 of G-CSF administration. The results of our study show that a total value of CD34+ cells ranging from 48.44 x 10(6) to 270.37 x 10(6) can be collected from donors with a white cell count ranging from 40.50 x 10(3) microL-1 to 51.34 x 10(3) microL-1 and mononuclear cells ranging from 16.42 to 20.37%. The Excel and the MCS 3p seem to differ from the other machines in terms of higher CD34+ cell collection efficiency. The Excel appears to be even more efficient than the MCS 3p, but this may not reflect reality because the Excel processes 12 L of blood while the MCS 3p employs an 8 L procedure. All the machines showed satisfactory results in terms of yield and quality of the harvests.

Antigens, CD34↗
PubMed1996

High-dose chemo-radiotherapy followed by autologous Philadelphia chromosome-negative blood progenitor cell transplantation in patients with chronic myelogenous leukemia.

Twenty-three patients with chronic myelogenous leukemia in early chronic phase (ECP) and not previously treated with alpha-interferon (IFN-alpha) (10 patients), in ECP but pretreated with IFN-alpha (<12 months) (seven patients) and in late chronic phase (LCP) pretreated with IFN-alpha (>12 months) (six patients) underwent autografting with Philadelphia (Ph) chromosome-negative blood progenitor cells (BPCs) (20 patients), or partially/totally Ph-positive BPCs (three patients), previously mobilized during the early phase of recovery after aplasia induced by intensive chemotherapy. The conditioning regimen consisted of high-dose chemotherapy alone or followed by total body irradiation (TBI). Recombinant G-CSF was given after BPCs infusion on day +8. All patients in ECP not pretreated with IFN-alpha are alive and five of them are Ph-negative in the marrow after autografting. Six of seven patients autografted with Ph-negative BPCs in the group of ECP pretreated with IFN-alpha (<12 months) are alive and two of them are still Ph-negative in the marrow. In the same group, the only patient transplanted with partially Ph-positive BPCs, died of blastic transformation 2 months after reinfusion. Three patients (two patients autografted with Ph-negative BPCs and one patient with Ph-positive BPC) in the group of LCP pretreated with IFN-alpha >12 months are alive but Ph-positive after autografting. The other three patients of the same group died of procedure-related toxicity (two patients) and blastic transformation (one patient). Seventeen patients (10/10 ECP not pretreated with IFN-alpha; 5/7 ECP pretreated with IFN-alpha and 2/6 LCP pretreated with IFN-alpha) of 23 autografted patients were treated with IFN-alpha +/- IL-2. Toxicities after autografting were mostly related to myelosuppression, particularly thrombocytopenia. All patients of the two groups pretreated with IFN-alpha developed febrile episodes during the aplastic phase following BPCs reinfusion. No patient autografted in ECP and those not pretreated with IFN-alpha developed febrile episodes. This is also probably due to the use of i.v. antibiotic and antimicotic prophylaxis when neutrophils were < or = 1 x 10(9)/l after autografting. Greater toxicity was observed in patients pretreated with IFN-alpha, being lethal in two cases in LCF. In conclusion, the "in vivo' manipulation approach employed in our institution is a safe procedure and it results in a high collection of Ph-negative cells in the blood if the cells are harvested: (1) in early chronic phase; (2) in early phase of recovery after chemotherapy-inducing aplasia; (3) in patients not extensively pretreated with IFN-alpha. The data presented here have shown encouraging trends in chronic phase of CML and offer new perspective for patients without an HLA-identical donor or for patients who do not respond to IFN-alpha.

Adult↗
PubMed1996

The Fresenius continuous autotransfusion system (CATS): preliminary studies and application.

A new CFC apparatus for intraoperative blood salvage (CATS) has been introduced by Fresenius and submitted to preliminary evaluation at our hemapheresis unit. The volume of shed blood submitted to washing was 1714 +/- 496 with a hematocrit of 19% and the volume of PRBC ready for transfusion 297.9 ml with hematocrit of 64.3%. Elimination of contaminant activated platelets and WBC was 92% and 74% respectively. Elimination of contaminants such as protein, free hemoglobin, LDH and K ions was always over 95%. Regular application of CATS is warrented after our study.

Blood Transfusion, Autologous↗
PubMed1995

Four-step high-dose sequential chemotherapy with double hematopoietic progenitor-cell rescue for metastatic breast cancer.

PURPOSE: High-dose chemotherapy produces high complete remission (CR) rates and some survival advantage in patients with metastatic breast cancer (BC). A current issue is the possibility that these patients may have an even better prognosis with multiple high-dose treatments. In this study, we evaluated the feasibility of a four-step, high-dose sequential chemotherapy (HDSC) with double autologous hematopoietic progenitor-cell rescue. We also tested the hypothesis that peripheral-blood progenitor cells (PBPCs) harvested following a single recruitment with cyclophosphamide (CY) and granulocyte-macrophage colony-stimulating factor (GM-CSF) allow the safe administration of the whole HDSC with closely timed repeated courses of several non-cross-resistant agents. PATIENTS AND METHODS: The treatment plan included CY 7 g/m2, followed by GM-CSF 5 to 7 micrograms/kg/d administered by continuous intravenous (i.v.) infusion on days 2 to 14; PBPCs with or without bone marrow (BM) harvest; mitoxantrone (NOV) 60, 75, or 90 mg/m2 plus melphalan (L-PAM) 140 to 180 mg/m2 with hematopoietic rescue; methotrexate (MTX) 8 g/m2 plus vincristine (VCR) 1.4 mg/m2; and etoposide (VP-16) 1.5 g/m2 plus carboplatin (PP) 1.5 g/m2 with hematopoietic rescue. RESULTS: All 15 patients enrolled completed the entire treatment and there were no toxic deaths. Hematologic reconstitution was good at each step. The median number of days with an absolute neutrophil count (ANC) less than 100/microL and platelet count less than 20,000/microL were 8 and 3, respectively, after NOV plus L-PAM, and 7 and 4, respectively, after VP-16 plus PP. The main non-hematologic toxicity was mucositis, while organ toxicity was mild and reversible. CONCLUSION: This regimen is feasible, with acceptable toxicity. GM-CSF and PBPCs have a pivotal role, as they hasten hematologic reconstitution, abate toxicity, and allow rapid recycling.

Adult↗
PubMed1995

Intraoperative blood salvage (IOBS) in cardiac and vascular surgery.

The extensive application of IOBS has permitted a great reduction in the use of homoglous transfusion which presently represents the largest field of application of autologous systems. In cardiac and vascular surgery, IOBS is particularly useful to the goal of preventing the transmission of viral disorders and other adverse effects related to homologous transfusions. The apparatuses for IOBS may also be used to perform hemodilution and sequestration of a desired amount of platelet rich plasma. The appropriate usage of drugs in perioperative period and the promotion of hemostasis with IOBS are important costituents for the correct transfusional management of the patient. The feasibility and safety of IOBS is known and in expert hands it is an optimal method for the transfusional treatment of surgical patients.

Blood Transfusion, Autologous↗
PubMed1995

Intraoperative blood salvage: a new artificial organ?

Optimal blood supply is critical to modern medical practice. Among the different possibilities of improving the quality and safety of blood, it is generally felt that autologous donation has played an important role and has contributed to changing transfusional practices, mainly since the appearance of HIV and HCV on the blood transfusion scene. At the San Martino Hospital Immunohematology Service, the autotransfusion era began in 1985. Autologous predeposit donation was the first to be introduced, followed by intentional perioperative hemodilution, intraoperative blood salvage with DFC apparatuses and lastly post-operative blood salvage. From about 200 autologous donations in 1985 we reached 5,372 in 1993 and more than 6,000 autologous donations are expected for 1994. Only 189 intraoperative blood salvages, were carried out in 1986, 593 in 1989, 1,207 in 1993 and more than 1,500 blood salvage sessions are anticipated for 1994. In the meantime, the total number of homologous RBC units employed in the Hospital dropped from 45,000 in 1985 to 18,000 in 1994, with the Onco-hematological Divisions using approximately 10,000 units of packed RBC.

Blood Platelets↗
PubMed1995

Preparation and storage in Plasma-Lyte A of platelets collected with the cell separator CS3000 Plus equipped with the PLT30-separation and TNX6 collection chambers.

The last five years have been characterized by the presentation of new cell separators the main task of which is the collection of high yield-high quality platelets. The CS3000 is an old apparatus which has undergone rejuvenation to sustain the assault of its new competitors. The CS3000 Plus Omnix system is the latest version to be offered along with a combination of TNX-6 separation/PLT30 collection chambers for optimal platelet collection. In this paper we present our results with this apparatus and configuration after its adaptation to the collection and storage of platelets in a non-plasma medium, the Baxter Plasma-Lyte A. After separation the platelet product (PC) was left in the collection chamber and resuspended with 200 ml of Plasma-Lyte A instead of being resuspended in autologous plasma as usual. Plasma was collected in a separate bag (400-450 ml) for transfusion or fractionation purposes. PC quality was assessed by evaluating the platelet yield (4.17 +/- 1.8 x 10(11), and the WBC contamination (4.8 +/- 2.6 x 10(5)). The presence of platelet aggregates (platelet count after aggregate fixation with formalin/platelet count after disaggregation in EDTA), the aggregation induced by ADP, collagen and ristocetin, the hypotonic shock response and the stability of membrane glycoproteins (CD 62 - 62 - 63 - 36- 42b - 51) were measured in the preapheresis samples and in the PC immediately after, 24 and 72 hours after collection. These results were totally satisfactory as was the post-transfusion survival measured as corrected count increment in 10 transfusions to non refractory patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Adenosine Diphosphate↗
PubMed1994

Single-donor platelet concentrates produced along with packed red blood cells with the Haemonetics MCS 3p: preliminary results.

There has been an increasing interest in recent years over the qualitative superiority of single-donor platelets in the management of hemato-oncologic patients. The reasonable desire of both patients and physicians to limit the risks of transfusion along with the need for limiting the costs involved in this kind of therapy have led to application of multicomponent donations both in terms of double platelet concentrates and double products such as red blood cells (RBC) and platelets from the same donor. Single donor platelets and RBC have been collected in a semi-automated mode and only the very recent introduction of the Haemonetics MCS 3p with its SDP/RBC protocol provides a totally closed-system automated protocol for this combined collection. Twenty procedures have been carried out so far at our unit. In a mean of 87 minutes (6-7 passes), a mean of 3.1 x 10(11) platelets were collected along with approximately 220 mL of packed RBC. The leukocyte contamination of the platelet product was in the range of 0.4-1.1 x 10(7) (99% lymphocytes), and the quality of platelets was very satisfactory as measured by the hypotonic shock response, aggregation induced by ADP, collagen and ristocetin, morphology score, and membrane glycoproteins modifications. Equally satisfactory was the quality of the RBC concentrate, suspended in 80 mL of SAG-M, with a total hemoglobin (Hb) content approaching 55 g as compared to the normal Hb content of a standard RBC concentrate that is approximately 62 g.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1994

Intravenous immunoglobulin, plasmalymphocytapheresis and azathioprine in chronic progressive multiple sclerosis.

Five patients with a severe form of chronic progressive multiple sclerosis no longer responsive to steroid therapy were treated for six months with high-dose intravenous immunoglobulin associated with plasmalymphocytapheresis and azathioprine. In spite of an apparent initial stabilization of the course of the disease, EDSS assessment after six and twelve months of therapy revealed progressive disability in all patients.

Adult↗
PubMed1994

[Consensus conference. Saving blood: which are still the doubts and the problems?].

The consensus conference on blood saving has allowed us to formulate some interesting guidelines. The autologous and homologous transfusion require the patient's consent. For volemic replacement crystalloid solutions are used for phlebotomies below 10-15%, and colloid solutions for those greater than 10-15% of the blood mass. Severe isovolemic hemodilution (Ht < 20%) necessitates the reduction of the dosage of some drugs. A limit of Hb around 9 g/dl after phlebotomy may be acceptable in the absence of cerebral and coronary vascular disease. Phlebotomies are therefore possible also when the Hb values are 10 g/dl (Ht 30%). Hb values around 7 g/dl in the late postoperative period (from day 3 to 6) may be accepted only if well tolerated. The blood salvaged during surgery and at the beginning of the postoperative phase must always be centrifugated, washed and microfiltered. Subsequently, in the first 8 hours it is possible to reinfuse red cells after sedimentation and microfiltration. The techniques of predeposit, hemodilution and recovery are valid especially if associated with careful control of postoperative bleeding by means of aspiration under controlled pressure (at minimum negative values and sometimes positive ones), monitoring of blood loss from drainage and application of elastic compression bandages.

Blood Loss, Surgical↗
PubMed1993

Collection of peripheral blood hematopoietic progenitors (PBHP) from patients with severe aplastic anemia (SAA) after prolonged administration of granulocyte colony-stimulating factor.

The aim of this study was to test whether prolonged administration of granulocyte colony-stimulating factor (G-CSF) would allow the collection by leukapheresis of PBHP in patients with SAA. For this purpose, nine SAA patients, 7 to 46 years old, six of whom were enrolled at diagnosis of their disease and three after previous immunosuppression had failed, were treated with antilymphocyte globulin (ALG) (day 1 to 5), cyclosporin A (5 mg/kg/d orally) (day 6 to 90) and G-CSF 5 micrograms/kg/d (day 6 to 90). A total of 40 leukaphereses were performed, (range 2 to 7 per patient), between days +10 and +168 from G-CSF treatment. White blood cell count at the time of harvest ranged from 1.2 to 18.1 x 10(9)/L. Results can be summarized as follows: the median number of cells collected per patient was 5.0 x 10(8)/kg (range 2.6 to 18.7), the median number of CD34+ cells was 1.8 x 10(6)/kg (range 0.27 to 3.8) and the median number of colony-forming units granulocyte-macrophage (CFU-GM) was 3.9 x 10(4)/kg (range 0 to 39). Twenty leukaphereses performed between days +33 and +77 of G-CSF treatment grew granulocyte macrophages and erythroid colonies in vitro. No colony growth was obtained from 20 leukaphereses performed before day +33 or after day +80. In six patients the total number of CFU-GM recovered were in the range described for autologous peripheral blood stem cell grafts. (2.6 to 39 x 10(4)/kg). In conclusion, this study suggests that circulating hematopoietic progenitors can be recovered after ALG priming and after at least 1 month of G-CSF treatment in a proportion of patients with SAA. Whether these cells will be suitable for autologous transplantation remains to be determined.

Adolescent↗
PubMed1993

Hemopoietic stem cells: technical and methodological considerations.

Peripheral blood cells containing large numbers of granulocyte-macrophage colony forming units (CFU-GM) can be collected by leukapheresis. The number of aphereses needed to collect 2-7 x 10(8) mononuclear cells (MNC)/Kg and 2-50 x 10(4) CFU-GM/Kg during rapid hematopoietic recovery following cytotoxic chemotherapy-induced myelosuppression depends on type of disorder, type of chemotherapy, patients' clinical conditions, cell precounts, concomitant growth factor administration, optimal timing of leukapheresis, vascular access apheresis machines, and type of technique used. Because of the advent of growth factors, a broader window for collection of progenitors has been provided. This has determined an increasing interest for peripheral blood stem cell (PBSC) autotransplants, along with increasing problems due to the number and types of procedures to be performed and the quality and purity of the products. Presently most of the basic technical problems are solved and an array of third generation cell separators is offered for collection of progenitors. Their common features are safety controls, closed circuits, automation, and mechanical and electrical reliability. Performance and quality of the product may be totally different depending not only on the apparatus, but also on the patients' clinical conditions. These technical aspects will be rapidly discussed having in the due considerations the expected increase in the number of procedures.

Bone Marrow Transplantation↗