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1.
J Clin Apher ; 36(5): 711-718, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-34224175

RESUMEN

BACKGROUND: Apheresis procedures require adequate vascular access to achieve optimal inlet flow rates. While central lines provide such access, their placement and use are associated with risks; some of these risks are minimized if peripheral intravenous access can be established. However, peripheral intravenous access is associated with challenges in the pediatric setting. Research indicates that midline catheters reduce the use of CVADs and their associated risks. The use of midline catheters for apheresis has been reported recently in adults, but no studies have been published on their use in children. Thus, the purpose of this study was to evaluate the use of midline catheters for apheresis in the pediatric setting. METHODS: A retrospective observational study was conducted to evaluate the safety and efficacy of midline catheters in subjects who underwent apheresis at a pediatric hospital from April 2018 to August 2020. Demographic data, clinical data (diagnosis, procedure, catheter size, body mass), and outcome data (inlet flow rate, total blood volume [TBV] processed, procedure time, and cell counts) were collected. RESULTS: Eighteen subjects received a total of 100 midline catheters for 73 apheresis procedures. Inlet flow rates ranged from 45 to 80 mL/min, TBV ranged from 2872 to 20 000 mL, and procedure time ranged from 1.25 to 7 hours. Inlet flow rates met or exceeded the recommended inlet flow rates for apheresis in children and adults (P < .0001). No adverse events occurred. CONCLUSION: Midline catheters provide safe and effective vascular access for apheresis. Future research should include younger patients with lower body mass.


Asunto(s)
Eliminación de Componentes Sanguíneos/instrumentación , Cateterismo Periférico/instrumentación , Catéteres , Adolescente , Adulto , Niño , Femenino , Humanos , Masculino , Estudios Retrospectivos , Donantes de Tejidos , Adulto Joven
2.
J Clin Apher ; 36(4): 606-611, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-33843086

RESUMEN

BACKGROUND: Peripheral venous access has been promoted as the safest, quickest, and most easily achievable route for performing apheresis procedures by the American Society for Apheresis' Choosing Wisely campaign. The current literature regarding catheter size and selection for both draw and return access is limited. Furthermore, the Infusion Nurses Society recommends using the smallest gauge catheter possible for the prescribed therapy in order to limit vein trauma and phlebitis. Since there is a lack of evidence to guide selection of catheter size for return access during therapeutic apheresis procedures (TAPs) for patients with chronic conditions, this pilot study seeks to compare the performance of a 20-gauge fenestrated (20G) catheter to a standard 18-gauge (18G) intravenous catheter. METHODS: This non-inferiority pilot study randomized 26 subjects during 74 TAPs to either 20G fenestrated catheter or 18G standard catheter. RESULTS: There were no statistically significant differences for variables associated with the efficiency of the TAPs comparing 20G to 18G catheter for inlet rate (P = .8666), return pressure (P = .9427), blood processed (P = .4318), or total procedure time (P = .3184). CONCLUSION: The results from this pilot study suggest that 20G fenestrated catheter is non-inferior to 18G standard catheters. Additional studies with increased power are warranted to confirm these findings.


Asunto(s)
Eliminación de Componentes Sanguíneos/instrumentación , Cateterismo Periférico/instrumentación , Catéteres , Adulto , Eliminación de Componentes Sanguíneos/métodos , Cateterismo , Cateterismo Periférico/métodos , Comorbilidad , Estudios de Equivalencia como Asunto , Femenino , Hemoglobinas/análisis , Humanos , Masculino , Persona de Mediana Edad , Agujas , Proyectos Piloto
3.
Ther Apher Dial ; 25(4): 432-436, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-33885215

RESUMEN

Several adsorptive type devices for ulcerative colitis are used for the induction of remission in patients with active severe disease worldwide. In 2020, the novel apheresis device Immunopure for ulcerative colitis was launched in Japan. Immunopure, like the polyethylene terephthalate column, uses polyarylate, a type of polyester resin, as the adsorbent. Similar to the cellulose acetate column, Immunopure is filled with adsorbent beads and expected to provide ease of use, with minimal risk of column clogging. Immunopure adsorbs leukocytes and platelets, especially activated platelets and platelet-leukocyte aggregates. In this article, the capability of Immunopure is evaluated from clinical perspective based on a clinical trial in Japan/Europe. As a result, Immunopure is comparable to other products in clinical effectiveness and indicated for the treatment of patients with refractory moderate ulcerative colitis, making it highly useful in clinical practice.


Asunto(s)
Eliminación de Componentes Sanguíneos/instrumentación , Adsorción , Celulosa/análogos & derivados , Colitis Ulcerosa/terapia , Diseño de Equipo , Europa (Continente) , Femenino , Humanos , Masculino , Poliésteres , Tereftalatos Polietilenos , Inducción de Remisión
4.
J Clin Apher ; 36(4): 574-583, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-33783856

RESUMEN

BACKGROUND: Fibrinogen reconstitution after therapeutic apheresis has been poorly studied. Apheresis modalities, for example, plasma exchange (PE), double-filtration plasmapheresis (DFPP), or selective immunoadsorption (IA), may have different impacts. METHODS: We retrospectively investigated therapeutic apheresis sessions performed at our center across four modalities (PE, DFPP, and IA with or without plasma filtration). Fibrinogen levels were assessed at the beginning and end of each apheresis session, and immediately before the subsequent session. We adjusted measurements on hematocrit values to account for hemoconcentration. RESULTS: Between January 10, 2016 and March 2, 2020, we included 90 patients for a total of 754 apheresis sessions (PE: 35; DFPP: 351; IA only: 109; IA + plasma filtration: 259). Each patient received a median of five sessions (1Q 3; 3Q 9); median plasma volume treated was 5.5 L (1Q 4.3 L; 3Q 7.0 L). Within a session, DFPP and PE induced a significantly greater depletion of fibrinogen than both IA modalities, even after adjustment for the treated plasma volume. Median fibrinogen reconstitution was 0.8 (0.4-1.2) g/L (median time between sessions: 38 hours). In multivariate analysis, fibrinogen reconstitution was significantly associated with intersession time (+0.66 g/L/log-hour P < .001), apheresis modality (ANOVA; P < .001), initial fibrinogen concentration (+0.15 g/L per gram of fibrinogen; P < .001), and the last fibrinogen concentration from the previous apheresis session (-0.14 g/L per gram of fibrinogen; P < .001). In a model that considered hemoconcentration, the results were unchanged. CONCLUSIONS: We demonstrate that fibrinogen reconstitution was highly variable between patients and apheresis sessions. Apheresis modalities had a significant impact on fibrinogen reconstitution, regardless of hemoconcentration.


Asunto(s)
Eliminación de Componentes Sanguíneos/instrumentación , Eliminación de Componentes Sanguíneos/métodos , Fibrinógeno/química , Técnicas de Inmunoadsorción , Intercambio Plasmático/métodos , Plasmaféresis/métodos , Fibrinógeno/análisis , Hematócrito , Humanos , Modelos Lineales , Análisis Multivariante , Estudios Retrospectivos
5.
Artif Organs ; 45(9): 1104-1113, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-33617653

RESUMEN

Activation of the complement system and leukocytes by blood-membrane interactions may further promote arteriosclerosis typically present in patients on lipoprotein apheresis. As clinical data on the hemocompatibility of lipoprotein apheresis are scarce, a controlled clinical study comparing two different types of plasma separation and fractionation membranes used in double-filtration lipoprotein apheresis was urgently needed, as its outcome may influence clinical decision-making. In a prospective, randomized, crossover controlled trial, eight patients on double-filtration lipoprotein apheresis were subjected to one treatment with recent polyethersulfone (PES) plasma separation and fractionation membranes and one control treatment using a set of ethylene-vinyl alcohol copolymer (EVAL) membranes. White blood cell (WBC) and platelet (PC) counts, complement factor C5a and thrombin-antithrombin III (TAT) concentrations were determined in samples drawn at defined times from different sites of the extracorporeal blood and plasma circuit. With a nadir at 25 minutes, WBCs in EVAL decreased to 33.5 ± 10.7% of baseline compared with 63.8 ± 22.0% at 20 minutes in PES (P < .001). The maximum C5a levels in venous blood reentering the patients were measured at 30 minutes, being 30.0 ± 11.2 µg/L with EVAL and 12.3 ± 9.0 µg/L with PES (P < .05). The highest C5a concentrations were found in plasma after the plasma filters (EVAL 56.1 ± 22.0 µg/L at 15 minutes vs PES 23.3 ± 15.2 µg/L at 10 minutes; P < .001). PC did not significantly decrease over time with both membrane types, whereas TAT levels did not rise until the end of the treatment without differences between membranes. Regarding lipoprotein(a) and low-density lipoprotein (LDL) cholesterol removal, both membrane sets performed equally. Compared with EVAL, PES membranes cause less leukocyte and complement system activation, the classical parameters of hemocompatibility of extracorporeal treatment procedures, at identical treatment efficacy. Better hemocompatibility may avoid inflammation-promoting effects through blood-material interactions in patients requiring double-filtration lipoprotein apheresis.


Asunto(s)
Eliminación de Componentes Sanguíneos/instrumentación , Hiperlipidemias/terapia , Lipoproteínas/metabolismo , Membranas Artificiales , Polímeros/química , Polivinilos/química , Sulfonas/química , Adulto , Anciano , Materiales Biocompatibles , Recuento de Células Sanguíneas , Estudios Cruzados , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos
6.
J Clin Apher ; 36(1): 28-33, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-32882095

RESUMEN

INTRODUCTION: Autologous peripheral blood stem cell (PBSC) transplantation has become a standard treatment option for many oncology patients. The aim of this study was to evaluate the performance of two cell separators, Spectra Optia (Terumo BCT, Japan) and Amicus (Fresenius-Kabi) for autologous PBSC collection. METHODS: We retrospectively evaluated 56 apheresis by Spectra Optia with Continuous Mononuclear Cell Collection (cMNC) from 20 patients, and 50 apheresis by Amicus from 27 patients between December 2018 and December 2019. CD34+ collection efficiency (CE2) and platelet (PLT) loss were evaluated. RESULTS: There was no significant difference in CD34+ CE2 between Spectra Optia with cMNC (median, 28.8%) and Amicus (median, 33.1%; P = 0.537). PLT loss was significantly lower in Amicus (median, 28.6%) than in Spectra Optia with cMNC (median, 37.8%; P = 0.009). CONCLUSION: CD34+ CE2 was comparable between Spectra Optia and Amicus, and PLT loss was significantly lower in Amicus. To the best of our knowledge, this is the first report comparing autologous PBSC collection of the Spectra Optia and Amicus. These results may provide general guidance with regard to device selection to apheresis clinics that use both separators for optimal outcomes depending on each patient's characteristics.


Asunto(s)
Eliminación de Componentes Sanguíneos/métodos , Movilización de Célula Madre Hematopoyética/métodos , Células Madre de Sangre Periférica/citología , Adulto , Eliminación de Componentes Sanguíneos/instrumentación , Femenino , Movilización de Célula Madre Hematopoyética/instrumentación , Humanos , Masculino , Persona de Mediana Edad , Trasplante Autólogo , Adulto Joven
7.
J Emerg Nurs ; 47(1): 21-27, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33189362

RESUMEN

INTRODUCTION: The PowerFlow implantable apheresis intravenous port is a venous access device for therapeutic apheresis procedures. In this case review article, we identify key similarities and differences between apheresis PowerFlow ports and traditional ports. We also list strategies that emergency departments can implement to aid in correct port identification. METHODS: Using a case review format, we describe the clinical presentation of a 33-year-old female with neuromyelitis optica who was evaluated in the emergency department for an acute exacerbation. She had a history of outpatient apheresis procedures that made use of bilateral PowerFlow ports. Mistaken for a conventional port, the right PowerFlow port was accessed with a Huber needle rather than the appropriate catheter-over-needle device. On infusion of intravenous fluids, the patient experienced pain and swelling. Ultimately, the port malfunctioned and was eventually replaced. RESULTS: A subsequent root cause analysis identified opportunities for education and aids to improve port identification. To this end, strategies were implemented to appropriately identify the PowerFlow port using at least 2 of the following methods: (1) look in the patient's chart for record of an implantable apheresis intravenous port; (2) check the port identification card, bracelet, or keychain issued at insertion; (3) palpate the port to look for the rounded top and hollow concave entry point; and (4) use x-ray or fluoroscopy to identify radiopaque port markers. CONCLUSION: When a patient with a history of apheresis procedures presents with an implanted port, steps should be taken to ensure correct identification and access.


Asunto(s)
Eliminación de Componentes Sanguíneos/instrumentación , Neuromielitis Óptica/terapia , Adulto , Catéteres de Permanencia , Servicio de Urgencia en Hospital , Diseño de Equipo , Análisis de Falla de Equipo , Femenino , Humanos , Agujas , Análisis de Causa Raíz , Brote de los Síntomas
8.
Cerebrovasc Dis Extra ; 10(3): 148-158, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33091902

RESUMEN

INTRODUCTION: The delipid extracorporeal lipoprotein filter from plasma (DELP) has been approved for the treatment of acute ischemic stroke (AIS) by the China Food and Drug Administration, but its effectiveness and mechanism are not yet fully determined. The purpose of this study was to evaluate the effect of DELP treatment on AIS patients after intravenous thrombolysis. METHODS: A retrospective study was performed on AIS patients with no improvement within 24 h after intravenous thrombolysis who were subsequently treated with or without DELP. Primary outcome was the proportion with a modified Rankin scale (mRS) of 0-1 at 90 days. Secondary outcomes were changes in National Institute of Health Stroke Scale (NIHSS) score from 24 h to 14 days after thrombolysis, and the rate of improvement in stroke-associated pneumonia (SAP). The main safety outcomes were the rates of symptomatic intracranial hemorrhage and mortality. To investigate its mechanisms, serum biomarkers were measured before and after DELP. RESULTS: A total of 252 patients were recruited, 63 in the DELP group and 189 matched patients in the NO DELP group. Compared with the NO DELP group, the DELP group showed an increase in the proportion of mRS 0-1 at 90 days (p = 0.042). More decrease in NIHSS from 24 h to 14 days (p = 0.024), a higher rate of improvement in SAP (p = 0.022), and lower mortality (p = 0.040) were shown in DELP group. Furthermore, DELP decreased levels of interleukin (IL)-1ß, E-selectin, malondialdehyde, matrix metalloprotein 9, total cholesterol, low-density lipoprotein, and fibrinogen, and increased superoxide dismutase (p< 0.05). CONCLUSIONS: DELP following intravenous thrombolysis should be safe, and is associated with neurological function improvement, possibly through multiple neuroprotective mechanisms. Prospective trials are needed.


Asunto(s)
Eliminación de Componentes Sanguíneos/instrumentación , Fibrinolíticos/administración & dosificación , Filtración/instrumentación , Accidente Cerebrovascular Isquémico/terapia , Lipoproteínas/sangre , Terapia Trombolítica , Activador de Tejido Plasminógeno/administración & dosificación , Administración Intravenosa , Anciano , Eliminación de Componentes Sanguíneos/efectos adversos , Bases de Datos Factuales , Femenino , Fibrinolíticos/efectos adversos , Estado Funcional , Humanos , Accidente Cerebrovascular Isquémico/sangre , Accidente Cerebrovascular Isquémico/diagnóstico , Masculino , Persona de Mediana Edad , Recuperación de la Función , Estudios Retrospectivos , Terapia Trombolítica/efectos adversos , Factores de Tiempo , Activador de Tejido Plasminógeno/efectos adversos , Resultado del Tratamiento
9.
Curr Opin Hematol ; 27(6): 415-422, 2020 11.
Artículo en Inglés | MEDLINE | ID: mdl-32889828

RESUMEN

PURPOSE OF REVIEW: A critical common step for blood-based ex-vivo gene and immune effector cell (IEC) therapies is the collection of target cells for further processing and manufacturing, often accomplished through a leukapheresis procedure to collect mononuclear cells (MNCs). The purpose of this review is to describe strategies to optimize the apheresis product cell yield and purity for gene and IEC therapies. Relevant data from the conventional bone marrow transplant literature is described where applicable. RECENT FINDINGS: Product yield is affected by three main factors: the peripheral blood concentration of the target cell, optimized by mobilizing agents, donor interventions or donor selection; the volume of peripheral blood processed, tailored to the desired product yield using prediction algorithms; and target cell collection efficiency, optimized by a variety of device and donor-specific considerations. Factors affecting product purity include characteristics of the donor, mobilizing agent, device, and device settings. SUMMARY: Strategies to optimize product yield and purity for gene and IEC therapies are important to consider because of loss of target cell numbers or function with downstream steps and detrimental effects of nontarget cells on further manufacturing and patient outcome.


Asunto(s)
Leucaféresis/métodos , Leucocitos/citología , Animales , Eliminación de Componentes Sanguíneos/instrumentación , Eliminación de Componentes Sanguíneos/métodos , Tratamiento Basado en Trasplante de Células y Tejidos , Terapia Genética , Humanos , Leucaféresis/instrumentación , Transfusión de Leucocitos , Leucocitos/metabolismo
11.
Ther Apher Dial ; 24(5): 530-547, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32567164

RESUMEN

The aim of this paper was to explain the insurance coverage status of therapeutic apheresis (excluding CHDF) in Japan, alongside the social system of medical reimbursement and concerns regarding the future sustainability of the healthcare system. Insurance schemes and premiums differed for individuals at different levels in the society (eg, municipal residents, employees, and public servants). Insurance premiums and their rates varied depending on the total household income, the number of people living together, age, and the place of residence. In addition, the medical expense subsidies for children through public expenditure were also described. Japan's generous insurance system and multiple medical expense subsidies provide financial support for patients. With Japan's history of medical expense subsidies based on the policy of supporting intractable diseases, we have established an environment where all citizens can receive therapeutic apheresis when needed if they are affected by a disease for which insurance coverage is indicated.


Asunto(s)
Eliminación de Componentes Sanguíneos/economía , Eliminación de Componentes Sanguíneos/instrumentación , Reembolso de Seguro de Salud/economía , Gastos en Salud , Humanos , Japón
12.
J Clin Apher ; 35(4): 290-293, 2020 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32384186

RESUMEN

INTRODUCTION: Calculation of the actual number of CD34+ cells in the collection product is based on the volume of the collected product and its concentration of CD34+ cells measured in the lab. The number of CD34+ cells infused correlates closely with the pace of hematopoietic reconstitution following autologous or allogeneic stem cell transplantation. METHODS: We studied peripheral blood stem cell collections in a single apheresis center with two Spectra Optia devices, using mononuclear cell collection or continuous mononuclear cell collection procedures. The collection volume displayed by the apheresis device was compared with the volume determined by a weight-based method. RESULTS: Fifty-two consecutive CD34 collections in 35 different donors (range 1-4 daily procedures per donor) were analyzed. The machines reported larger collection volumes (P < .001). The mean collection volume reported by the machine was 274.37 mL (range 162-396). The mean manually measured collection volume was 261.82 mL (range 155-371.40). Mean overestimation by machine was 12.53 mL (range -0.95 to 31.24; 95% confidence interval 10.94-14.11) or 4.88% (range -0.26 to 10.28). Median overestimation of the absolute number of CD34 was 10.29 × 106 (range -2.83 to 141.84 × 106 ). CONCLUSION: Both Spectra Optia machines overestimated the collection volume after peripheral blood stem cell collection. Although the mean variation falls within the expected range, in some cases, this overestimation may be clinically relevant if no other method of measurement is used.


Asunto(s)
Antígenos CD34/sangre , Eliminación de Componentes Sanguíneos/instrumentación , Eliminación de Componentes Sanguíneos/métodos , Hematología/instrumentación , Leucocitos Mononucleares/citología , Movilización de Célula Madre Hematopoyética/métodos , Humanos , Análisis Multivariante , Trasplante de Células Madre de Sangre Periférica , Células Madre de Sangre Periférica/citología , Reproducibilidad de los Resultados , Trasplante Autólogo , Trasplante Homólogo , Resultado del Tratamiento
13.
Fluids Barriers CNS ; 17(1): 23, 2020 Mar 16.
Artículo en Inglés | MEDLINE | ID: mdl-32178689

RESUMEN

BACKGROUND: Blood removal from cerebrospinal fluid (CSF) in post-subarachnoid hemorrhage patients may reduce the risk of related secondary brain injury. We formulated a computational fluid dynamics (CFD) model to investigate the impact of a dual-lumen catheter-based CSF filtration system, called Neurapheresis™ therapy, on blood removal from CSF compared to lumbar drain. METHODS: A subject-specific multiphase CFD model of CSF system-wide solute transport was constructed based on MRI measurements. The Neurapheresis catheter geometry was added to the model within the spinal subarachnoid space (SAS). Neurapheresis flow aspiration and return rate was 2.0 and 1.8 mL/min, versus 0.2 mL/min drainage for lumbar drain. Blood was modeled as a bulk fluid phase within CSF with a 10% initial tracer concentration and identical viscosity and density as CSF. Subject-specific oscillatory CSF flow was applied at the model inlet. The dura and spinal cord geometry were considered to be stationary. Spatial-temporal tracer concentration was quantified based on time-average steady-streaming velocities throughout the domain under Neurapheresis therapy and lumbar drain. To help verify CFD results, an optically clear in vitro CSF model was constructed with fluorescein used as a blood surrogate. Quantitative comparison of numerical and in vitro results was performed by linear regression of spatial-temporal tracer concentration over 24-h. RESULTS: After 24-h, tracer concentration was reduced to 4.9% under Neurapheresis therapy compared to 6.5% under lumbar drain. Tracer clearance was most rapid between the catheter aspiration and return ports. Neurapheresis therapy was found to have a greater impact on steady-streaming compared to lumbar drain. Steady-streaming in the cranial SAS was ~ 50× smaller than in the spinal SAS for both cases. CFD results were strongly correlated with the in vitro spatial-temporal tracer concentration under Neurapheresis therapy (R2 = 0.89 with + 2.13% and - 1.93% tracer concentration confidence interval). CONCLUSION: A subject-specific CFD model of CSF system-wide solute transport was used to investigate the impact of Neurapheresis therapy on tracer removal from CSF compared to lumbar drain over a 24-h period. Neurapheresis therapy was found to substantially increase tracer clearance compared to lumbar drain. The multiphase CFD results were verified by in vitro fluorescein tracer experiments.


Asunto(s)
Eliminación de Componentes Sanguíneos/métodos , Sangre , Catéteres , Líquido Cefalorraquídeo , Drenaje , Diseño de Equipo , Modelos Biológicos , Punción Espinal , Hemorragia Subaracnoidea/terapia , Adulto , Eliminación de Componentes Sanguíneos/instrumentación , Femenino , Humanos , Hidrodinámica , Imagen por Resonancia Magnética , Adulto Joven
14.
Blood Transfus ; 18(1): 67-76, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31403932

RESUMEN

BACKGROUND: Successful peripheral blood stem cell (PBSC) collection depends on optimal timing of apheresis, as usually determined by flow cytometry CD34-positive (+) cell count in peripheral blood (PB). Since this method is costly and labour-intensive, we evaluated the use of the Hematopoietic Progenitor Cell count programme on a Sysmex® XN haematologic analyser (XN-HPC) as a rapid and inexpensive alternative for predicting CD34+ cell count in PB samples. MATERIALS AND METHODS: Haematopoietic progenitor cell and CD34+ cell counts were compared using 273 PB samples collected from 78 healthy donors and 72 patients who underwent PBSC transplantation. We assessed the effectiveness of the XN-HPC in safely predicting pre-harvest CD34+ counts. The most efficient cut-off values of XNHPC were identified. We also evaluated the imprecision (coefficient of variation, CV) and functional sensitivity. RESULTS: Imprecision of the XN-HPC count was <6.3% on daily measurement of three levels of quality control material. Functional sensitivity was 8.9×106/L. A cut-off value of ≥62×106/L XN-HPC for multiple myeloma (MM) patients and ≥30×106/L for all other subjects had both 100% specificity and 100% positive predictive value for identifying samples with CD34+ cells ≥20×106/L. An XN-HPC threshold of <13×106/L identified preharvest CD34+ cell count <10×106/L with 100% sensitivity and 100% negative predictive value. DISCUSSION: The XN-HPC is a fast, easy and inexpensive test that can safely improve apheresis workflow thus possibly replacing other more expensive CD34 counts currently performed and promoting optimal timing of PBSC collection.


Asunto(s)
Antígenos CD34/metabolismo , Eliminación de Componentes Sanguíneos/métodos , Células Madre Hematopoyéticas/metabolismo , Trasplante de Células Madre de Sangre Periférica/métodos , Células Madre de Sangre Periférica/metabolismo , Eliminación de Componentes Sanguíneos/instrumentación , Recuento de Células , Células Madre Hematopoyéticas/citología , Humanos , Mieloma Múltiple/metabolismo , Células Madre de Sangre Periférica/citología , Reproducibilidad de los Resultados , Sensibilidad y Especificidad
15.
Transfus Apher Sci ; 59(2): 102682, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-31812492

RESUMEN

BACKGROUND: Granulocyte concentrates are mainly derived by apheresis technique from donors stimulated with granulocyte colony-stimulating factor and steroids. The automated blood processing system Reveos, which is now increasingly used across the world, separates whole blood into four components, including a residual leukocyte unit containing granulocytes. The aim of this study was to produce an alternative granulocyte concentrate from leukocyte units produced by the Reveos system, and to assess the function of the granulocytes. METHODS: The number of granulocytes was measured in residual leukocyte units, derived from whole blood donations, with different volumes ranging from 10 to 40 ml. After deciding the optimal volume of the leukocyte unit (30 ml), ten ABO-matched units were pooled to form a granulocyte concentrate. The function of the granulocytes from residual leukocyte units was assessed by analyzing surface markers, phagocytosis of yeast, and production of reactive oxygen species. RESULTS: Residual leukocyte units with a volume of 30 ml contained a median number of 0,7 × 109 granulocytes, and granulocyte concentrates prepared from ten pooled 30 ml-leukocyte units contained a median number of 6,3 × 109 granulocytes. Granulocytes derived from residual leukocyte units displayed surface markers associated with granulocyte function, and capability to phagocytose yeast and produce reactive oxygen species. CONCLUSIONS: Granulocyte concentrates prepared from residual leukocyte units contain in vitro functional granulocytes and may be considered as an alternative product in acute situations before regular granulocyte concentrates from stimulated donors are available.


Asunto(s)
Eliminación de Componentes Sanguíneos/instrumentación , Conservación de la Sangre/métodos , Granulocitos/metabolismo , Leucocitos/metabolismo , Humanos
16.
Int J Lab Hematol ; 42(2): 170-179, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-31830371

RESUMEN

INTRODUCTION: We evaluated the value of hematopoietic progenitor cells (HPCs) counted in Sysmex XN analyzers to predict the mobilization and collection of CD34+ cells in apheresis for stem cell transplantation. METHODS: Eighty patients who underwent stem cell transplantation were enrolled (50 autologous and 30 allogeneic). In the autologous group, patients were considered poor mobilizers when the CD34+ count was <10 × 106 /L or <20 × 106 /L in patients with multiple myeloma who were going to undergo two transplants. ROC curves were generated, and HPC cutoffs were calculated. RESULTS: The correlation between the HPC and CD34+ cell counts was good. Two algorithms were proposed. In the first algorithm, samples collected the day before apheresis, negative and positive HPC cutoffs were selected to detect poor and good mobilization and, therefore, the need or not to administer plerixafor. In the second algorithm, samples collected pre-apheresis, the negative HPC cutoff was an indication to delay apheresis; an HPC higher than the optimal cutoff was an indication to start apheresis. When the HPC values were between these cutoffs, there was an indication to count CD34+ cells for a better decision-making. Finally, in samples collected pre-apheresis, HPC counts could be used to predict patients who would have poor CD34+ cell collections. In the allogeneic group, all the donors mobilized well, and very few needed two apheresis procedures. CONCLUSIONS: The HPC count is useful for decision-making in the management of patients subjected to apheresis procedures to collect peripheral blood stem cells.


Asunto(s)
Automatización de Laboratorios , Eliminación de Componentes Sanguíneos/instrumentación , Eliminación de Componentes Sanguíneos/métodos , Recuento de Células/instrumentación , Recuento de Células/métodos , Movilización de Célula Madre Hematopoyética , Células Madre Hematopoyéticas/metabolismo , Adolescente , Adulto , Antígenos CD34/metabolismo , Biomarcadores , Recuento de Células/normas , Toma de Decisiones Clínicas , Manejo de la Enfermedad , Movilización de Célula Madre Hematopoyética/instrumentación , Movilización de Célula Madre Hematopoyética/métodos , Células Madre Hematopoyéticas/citología , Humanos , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Curva ROC , Reproducibilidad de los Resultados , Adulto Joven
18.
Cytotherapy ; 21(11): 1166-1178, 2019 11.
Artículo en Inglés | MEDLINE | ID: mdl-31668486

RESUMEN

BACKGROUND: Although dendritic cell (DC)-based cancer vaccines represent a promising treatment strategy, its exploration in the clinic is hampered due to the need for Good Manufacturing Practice (GMP) facilities and associated trained staff for the generation of large numbers of DCs. The Quantum bioreactor system offered by Terumo BCT represents a hollow-fiber platform integrating GMP-compliant manufacturing steps in a closed system for automated cultivation of cellular products. In the respective established protocols, the hollow fibers are coated with fibronectin and trypsin is used to harvest the final cell product, which in the case of DCs allows processing of only one tenth of an apheresis product. MATERIALS AND RESULTS: We successfully developed a new protocol that circumvents the need for fibronectin coating and trypsin digestion, and makes the Quantum bioreactor system now suitable for generating large numbers of mature human monocyte-derived DCs (Mo-DCs) by processing a complete apheresis product at once. To achieve that, it needed a step-by-step optimization of DC-differentiation, e.g., the varying of media exchange rates and cytokine concentration until the total yield (% of input CD14+ monocytes), as well as the phenotype and functionality of mature Mo-DCs, became equivalent to those generated by our established standard production of Mo-DCs in cell culture bags. CONCLUSIONS: By using this new protocol for the Food and Drug Administration-approved Quantum system, it is now possible for the first time to process one complete apheresis to automatically generate large numbers of human Mo-DCs, making it much more feasible to exploit the potential of individualized DC-based immunotherapy.


Asunto(s)
Reactores Biológicos , Eliminación de Componentes Sanguíneos , Vacunas contra el Cáncer , Técnicas de Cultivo de Célula , Células Dendríticas/citología , Células Dendríticas/fisiología , Monocitos/fisiología , Automatización de Laboratorios/normas , Reactores Biológicos/normas , Eliminación de Componentes Sanguíneos/instrumentación , Eliminación de Componentes Sanguíneos/métodos , Eliminación de Componentes Sanguíneos/normas , Vacunas contra el Cáncer/normas , Técnicas de Cultivo de Célula/instrumentación , Técnicas de Cultivo de Célula/métodos , Diferenciación Celular , Industria Farmacéutica/instrumentación , Industria Farmacéutica/normas , Adhesión a Directriz , Humanos , Inmunoterapia Adoptiva/métodos , Inmunoterapia Adoptiva/normas , Leucaféresis/instrumentación , Leucaféresis/métodos , Leucaféresis/normas , Materiales Manufacturados/normas , Monocitos/citología
19.
Lab Chip ; 19(22): 3787-3795, 2019 11 21.
Artículo en Inglés | MEDLINE | ID: mdl-31612163

RESUMEN

Fluid manipulation in microfluidic systems is often controlled by active pumps that are relatively large in size and require external power sources which limit their portability and use in limited-resource settings. In this work, portable, detachable, low-cost, and power-free paper pumps with engineered capillary tubes (referred to as "grooves") that can passively drive viscous fluids based on capillary action are presented. The proposed grooved paper pumps are capable of generating a controllable flow of complex biofluids within microfluidic devices with minimal user intervention and no external power sources. The pumping performance of grooved paper pumps in this study is tested with undiluted, unseparated whole blood samples - demonstrating successful transport of approximately 150 µL of blood within an average time of 5 minutes to 50 minutes, depending on their design parameters. Results for the flow rate of grooved paper pumps indicate that the number of grooves created within the porous paper determines the profile of the generated flow rate. The experimental data also show that as the number of grooves in the pumps is increased, the flow rate approaches a constant value for the entire duration of pumping before the pump becomes saturated. The promising performance of grooved paper pumps with whole blood offers potential applications of these small, disposable pumps in point-of-care diagnostics in which time is crucial and access to external power is limited.


Asunto(s)
Eliminación de Componentes Sanguíneos , Técnicas Analíticas Microfluídicas , Papel , Animales , Eliminación de Componentes Sanguíneos/instrumentación , Técnicas Analíticas Microfluídicas/instrumentación , Tamaño de la Partícula , Porosidad , Porcinos
20.
Nephrol Ther ; 15(6): 439-447, 2019 Nov.
Artículo en Francés | MEDLINE | ID: mdl-31585841

RESUMEN

Many apheresis techniques can be performed in a blood-bank facility or a hemodialysis (HD) facility. However, it makes sense to perform apheresis in a hemodialysis facility as apheresis involves extra-corporeal circuits and because HD can be performed at the same time as apheresis (tandem procedure). Apheresis techniques comprise therapeutic plasma exchange, double-filtration plasmapheresis, and its derivative (rheopheresis and LDL-apheresis), and immunoadsorption (specific and semi-specific). We have setup an apheresis platform in our hospital that fulfills health recommendations. This process has involved financial investment and significant human resources, and has enabled us to network with different specialties (neurology, hematology, vascular medicine). We have setup protocols according to the type of pathology to be treated by apheresis, and to monitor clinical and biological data for each apheresis session. The main side effects of apheresis are a fall in blood pressure when a session is initiated, an increase in fluid overload, hypocalcemia, and the loss of some essential plasmatic factors. However, these side-effects are easily identified and can be properly managed in real time. Within two-years, we have performed 1845 apheresis sessions (134 patients). Of these, 66 received apheresis before and/or after kidney transplantation for ABO and/or HLA incompatibility (desensitization), for humoral rejection, or in the setting of relapsing focal-segmental glomerulosclerosis. Our patients' outcomes have been similar to those reported in the literature. The other 68 patients had various conditions. Because our program is now well-established, we are currently forming a specialist center to train physicians and nurses in the various apheresis techniques/procedures.


Asunto(s)
Eliminación de Componentes Sanguíneos , Unidades de Hemodiálisis en Hospital/organización & administración , Eliminación de Componentes Sanguíneos/efectos adversos , Eliminación de Componentes Sanguíneos/instrumentación , Eliminación de Componentes Sanguíneos/métodos , Eliminación de Componentes Sanguíneos/estadística & datos numéricos , Ácido Cítrico/administración & dosificación , Ácido Cítrico/efectos adversos , Grupos Diagnósticos Relacionados , Glucosa/administración & dosificación , Glucosa/efectos adversos , Glucosa/análogos & derivados , Necesidades y Demandas de Servicios de Salud , Hospitales Universitarios/organización & administración , Humanos , Hipocalcemia/etiología , Hipotensión/etiología , Trasplante de Riñón , Grupo de Atención al Paciente , Utilización de Procedimientos y Técnicas , Diálisis Renal , Estudios Retrospectivos
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