The Japanese Society for Apheresis clinical practice guideline for therapeutic apheresis.

Most of the diseases for which apheresis therapy is indicated are intractable and rare, and each patient has a different background and treatment course prior to apheresis therapy initiation. Therefore, it is difficult to conduct large-scale randomized controlled trials to secure high-quality evidence. Under such circumstances, the American Society for Apheresis (ASFA) issued its guidelines in 2007, which were repeatedly revised until the latest edition in 2019. The ASFA guidelines are comprehensive. However, in the United States, a centrifugal separation method is mainly used for apheresis, whereas the mainstream procedure in Japan is the membrane separation method. The target diseases and their backgrounds are different from those in Japan. Due to these differences, the direct adoption of the ASFA guidelines in Japanese practice creates various problems. One of the features of apheresis in Japan is the development of treatment methods using hollow-fiber devices such as double filtration plasmapheresis (DFPP) and selective plasma exchange and adsorption-type devices such as polymyxin B-immobilized endotoxin adsorption columns. Specialists in emergency medicine, hematology, collagen diseases/rheumatology, respiratory medicine, cardiovascular medicine, gastroenterology, neurology, nephrology, and dermatology who are familiar with apheresis therapy gathered for this guideline, which covers 86 diseases. In addition, since apheresis therapy involves not only physicians but also clinical engineers, nurses, dieticians, and many other medical professionals, this guideline was prepared in the form of a worksheet so that it can be easily understood at the bedside. Moreover, to the clinical purposes, this guideline is designed to summarize apheresis therapy in Japan and to disseminate and further develop Japanese apheresis technology to the world. As diagnostic and therapeutic techniques are constantly advancing, the guidelines need to be revised every few years. In order to ensure the high quality of apheresis therapy in Japan, both the Japanese Society for Apheresis Registry and the guidelines will be inseparable.

Bacterial contamination and septic transfusion reaction rates associated with platelet components before and after introduction of primary culture: experience at a US Academic Medical Center 1991 through 2017.

BACKGROUND: The high incidence of septic transfusion reactions (STRs) led to testing being mandated by AABB from 2004. This was implemented by primary culture of single-donor apheresis platelets (APs) from 2004 and prestorage pooled platelets (PSPPs) from 2007. STUDY DESIGN/METHODS: Platelet (PLT) aliquots were cultured at issue and transfusion reactions evaluated at our hospital. Bacterial contamination and STR rates (shown as rates per million transfusions in Results) were evaluated before and after introduction of primary culture by blood centers that used a microbial detection system (BacT/ALERT, bioMerieux) or enhanced bacterial detection system (eBDS, Haemonetics). RESULTS: A total of 28,457 PLTs were cultured during pre-primary culture periods (44.7% APs; 55.3% at-issue pooled PLTs [AIPPs]) and 97,595 during post-primary culture periods (79.3% APs; 20.7% PSPPs). Forty-three contaminated units were identified in preculture and 34 in postculture periods (rates, 1511 vs. 348; p < 0.0001). Contamination rates of APs were significantly lower than AIPPs in the preculture (393 vs. 2415; p < 0.0001) but not postculture period compared to PSPPs (387 vs. 198; p = 0.9). STR rates (79 vs. 90; p = 0.98) were unchanged with APs but decreased considerably with pooled PLTs (826 vs. 50; p = 0.0006). Contamination (299 vs. 324; p = 0.84) and STR rates (25 vs. 116; p = 0.22) were similar for PLTs tested by BacT/ALERT and eBDS primary culture methods. A change in donor skin preparation method in 2012 was associated with decreased contamination and STR rates. CONCLUSION: Primary culture significantly reduced bacterial contamination and STR associated with pooled but not AP PLTs. Measures such as secondary testing near time of use or pathogen reduction are needed to further reduce STRs.

Automated Good Manufacturing Practice-compliant generation of human monocyte-derived dendritic cells from a complete apheresis product using a hollow-fiber bioreactor system overcomes a major hurdle in the manufacture of dendritic cells for cancer vaccines.

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.

Apheresis red blood cells associated with repeated hemolysis during blood priming of the Cellex Photopheresis System.

Extracorporeal photopheresis (ECP) in young pediatric patients has a risk for procedural hypotension and anemia due to extracorporeal fluid shifts. A standard mitigation policy in these patients is to prime the device with packed red blood cells (RBC) or whole blood. We now report multiple episodes of hemolysis while attempting to prime the Therakos Cellex in a pediatric transplant patient undergoing a course of ECP for severe graft-vs-host-disease. Over the course of 40 ECP treatments, hemolysis was observed on five occasions. An extensive investigation found an association between hemolysis and apheresis RBC (A-RBC). Of 46 RBC units dispensed for blood priming, hemolysis occurred with 22% (4 of 18) of A-RBC and accounted for 80% (4 of 5) of all hemolysis episodes. Hemolysis was significantly higher with A-RBC when compared with RBC collected by whole blood donations (WB-RBC: 3.5% [1 of 28]; P = .049). A comparison of RBC attributes, including unit age, showed that hemolyzed A-RBC units tended to be younger than both nonhemolyzed RBC (6.5 vs 10.3 days, P = .018) and WB-RBC (8.5 days, P = .10). We hypothesize that A-RBC may exhibit "sublethal" RBC damage following prior exposure to centrifugal shear and negative forces at the time of collection, leading to a decrease in RBC deformability and increased susceptibility to hemolysis. This is the first report showing an increased susceptibility to hemolysis with A-RBC during priming of the Cellex.

Pathogen reduced plasma products: a clinical practice scientific review from the AABB.

BACKGROUND: A small body of literature assessing the efficacy and safety of pathogen reduced (PR) plasma has been published. STUDY DESIGN AND METHODS: An AABB committee systematically reviewed the literature and graded the clinical trial evidence with the assistance of a GRADE expert. RESULTS: Most studies identified were low quality and had a small sample size; in addition, efficacy and safety were monitored in many different ways making it difficult to quantify therapeutic benefit and risk. The data analyzed in this systematic review showed that pathogen inactivation did not adversely affect the efficacy of S/D or amotosalen plasma transfusions in any patient population studied. In addition, there were no significant safety issues for these patient populations, other than the specific contraindications noted in their respective package inserts. CONCLUSION: Larger, well-designed trials are needed to further evaluate the efficacy and safety of all of the PR plasma products.

Safety and efficacy of autologous mononuclear cell and stem cell apheresis in very low-weight children-Experience at a single center.

BACKGROUND: Apheresis in children with low body weight is technically limited by their tolerance of the extracorporeal blood volume. STUDY DESIGN AND METHODS: This paper presents a single-center experience with 23 procedures in 12 children with weights between 5.2 and 9.5 kg using the Spectra Optia mononuclear cell (MNC) protocol with blood priming. RESULTS: The average procedure duration was 158 minutes, and the median processed blood volume was 316 mL/kg. The white blood cell (WBC), platelet (PLT), and hemoglobin (HGB) values showed a downward trend with increased volume of processed blood. The post-apheresis HGB concentration was increased in all procedures due to initial priming with packed red blood cells (PRBCs), but this effect disappeared at a level of ~400 mL of processed blood/kg. The median volume of the cellular product was 36 mL, the WBC count was 153 K/µL, the hematocrit (HCT) was 1.5%, the PLT count was 602 K/µL, the WBC collection efficacy (CE2) was 13.2%, and the PLT CE2 was 9.5%. The median CD34+ CE2 was 28%, and interpolation of the CD34+ CE2 yielded a Y-intercept value of 32%. Higher pre-collection CD34+ counts resulted in higher CD34+ yields. No correlation was found between the pre-collection CD34+ results and CD34+ CE2. CONCLUSION: The analyzed data demonstrated the feasibility and safety of apheresis in very low-weight children. The laboratory abnormalities were asymptomatic and citrate toxicity was mild. Visual control of clogging with manual adjustment of the citrate infusion rate is important to reduce exposure to citrate.

A proposal for sectorial organizing and quality standards in therapeutic apheresis: The therapeutic apheresis unit (TAU) standards.

Therapeutic apheresis (TA) includes a wide range of therapeutic procedures based on the separation of blood components and the collection of cells with therapeutic activity or the removal of unwanted plasma or cellular components involved in the etiology of various hematologic, renal, neurological, and medical diseases. The complexity of these interventions requires an organizing model to assure a proper clinical environment, technology, quality requirements, and personnel as well as an active system for outcome monitoring for safety and efficacy. Finally, a structured organizing model may favor the efficiency of the TA unit and economic affordability. Here, we describe the more relevant characteristics of a model of TA standards, named TA unit (TAU) standards, that may help to establish a quality program in units working in the field of TA (shown as supplementary material and available at http://www.ifeit.org/pdf/TAU_Standards_3.0.pdf.

Audits of collection and apheresis centers: guidelines by the World Marrow Donor Association Working Group Quality and Regulation.

According to the Standards of the World Marrow Donor Association (WMDA), unrelated stem cell donor registries and donor centers are responsible for compliance of their collection and apheresis centers with these Standards. To ensure high stem cell product quality and high standards for safety and satisfaction of voluntary unrelated stem cell donors, we here present guidelines for audits of collection and apheresis centers that can be used by new and established donor registries, as well as by collection centers in preparation of audits. We define the general requirements and recommendations for collaboration with the collection and apheresis centers and define critical procedures for the collection of the stem cell product, such as information session, medical assessment, product collection, quality controls, product handover for transportation, and donor follow-up. The specific guidelines are accompanied by detailed checklists and forms that can be found in Supplementary Information and may be used during an initial or follow-up on-site or paper-based audit.

Change of apheresis device decreased the incidence of severe acute graft-versus-host disease among patients after allogeneic stem cell transplantation with sibling donors.

BACKGROUND: The composition of the graft used for allogeneic hematopoietic stem cell transplantation (HSCT) is important for the treatment outcome. Different apheresis devices may yield significant differences in peripheral blood stem cell graft cellular composition. We compared stem cell grafts produced by Cobe Spectra (Cobe) and Spectra Optia (Optia) with use of the mononuclear cell (MNC) protocol, and evaluated clinical outcome parameters such as graft-versus-host disease (GvHD), transplant-related mortality (TRM), relapse, and overall survival. STUDY DESIGN AND METHODS: During 5 years, 31 Cobe Spectra and 40 Spectra Optia grafts were analyzed for CD34, CD3, CD4, CD8, CD19, and CD56 cell content. Clinical outcome parameters were correlated and compared between the two patient groups using different apheresis devices. RESULTS: Optia grafts contained fewer lymphocytes compared to Cobe (p < 0.001). Optia grafts had a significantly lower incidence of acute GvHD Grades II through IV (Cobe 45% vs. Optia 23%; p = 0.039) and TRM (16% vs. 2.5%; p < 0.05) but higher chronic GvHD (32% vs. 67%; p = 0.005) compared to Cobe grafts. Finally, the multivariate analysis showed a significant correlation among the different apheresis devices and both acute GvHD II through IV and severe chronic GvHD. The multivariate analysis also showed a significant correlation between the CD3+ cell dose and the incidence of severe acute GvHD. CONCLUSION: Optia-obtained grafts yielded a lower acute GvHD Grades II-IV and TRM risk, but had no impact on relapse or overall survival in this study. Understanding and further improvement of peripheral blood stem cell (PBSC) apheresis techniques may be used in the future to personalize HSCT by, for example, fine-tuning the GvHD incidence.

Impact of apheresis automation on procedure quality and predictability of CD34+ cell yield.

Success of peripheral blood stem cell (PBSC) collections depends on patient biological parameters and stable apheresis device performance. We investigated product quality and factors influencing main apheresis procedure outcomes including CD34+ collection efficiency (CE), product volume or platelet CE. We also assessed different CD34+ cell yield prediction algorithms. Autologous PBSC collections by Spectra Optia from myeloma and lymphoma patients were analyzed. Complete blood count (CBC) from patient preprocedure and from collected products were assessed. (1) Product yield was calculated, (2) Product CBC was correlated with patient preprocedure variables, and (3) Predictions of CD34+ yields based on (a) product CD34+ cell concentration in samples after two or four chamber flushes or (b) traditional CE2 benchmark, were compared. 62 procedures in 41 patients were analyzed. 84% of all procedures were run without operator intervention. Median CD34+ CE2 was 56.9% (48.8%-65.2%) and quite stable irrespective of patient conditions, with minor influence from patient white blood cell (WBC) precounts (rs  = -.47; P < .001). Platelet loss correlated with WBC precount (rs  = .46; P < .001), product volume (rs  = .71; P < .0001) and number of chambers collected (rs  = .72; P < .0001). CD34+ cell yield was better predicted based on (a) product CD34+ cell concentration from samples after 2 and 4 chamber flushes, respectively (rs  = .969; P < .0001 and rs  = .9648; P < .0001) than based on (b) CE2 formula (rs  = .8262, P < .0001). Spectra Optia provides good quality PBSC products with stable and predictable yield regardless of starting conditions. CD34+ sampling of product after few chamber flushes could be used to predict CD34+ yield.

Comparison of the CMNC and MNC apheresis protocol for the collection of T-cells showed comparable outcome: An observational study in a single centre.

BACKGROUND: An increasing demand for human lymphocytes require an efficient, reliable and reproducible lymphocyte process. Here, we compare the Spectra Optia® CMNC protocol with the Optia MNC platform in unmobilised donor lymphocyte collections. PURPOSE: To establish and compare the feasibility, efficiency, and practicability of the two apheresis protocols. METHODS: Data was collected prospectively from 60 non-cytokine stimulate donors who underwent a total of 64 T-cell collection procedures. Of these, 24 procedures were performed in the CMNC cohort and 40 procedures in the MNC cohort. All donors in the CMNC group were related; all donors in the MNC group were donors from a registry. Donor characteristics, procedure parameters and cellular product content were analysed and compared. RESULTS: Donor characteristics and full blood count results were comparable, except the median white blood cell count, which was higher in the CMNC cohort (6.87 vs. 5.58 ×109 /L, P < .005). This resulted in higher lymphocyte (1.95 vs. 1.57 ×109 /L, P < .009) and CD3+ cell counts (1476 vs. 1060/L, P < .02). A total blood volume processed of 2.0 resulted in i) run time (222 vs. 242 min), ii) product volume (192 vs. 183 ml), iii) platelet content (2140 vs. 1345 ×106 /ml, P < .003). CD3+ CE2 (%): 54.7 vs. 50.4. CONCLUSION: The CMNC and MNC protocols are reliable, efficient and comparable in performance parameters and cell composition of final product, respectively. One advantages of the CMNC protocol is the potential ability to tailor the cell composition of the final product accordingly to demands from cell processing laboratories.

Higher Donor Apheresis Blood Volumes Are Associated with Reduced Relapse Risk and Improved Survival in Reduced-Intensity Allogeneic Transplantations with Unrelated Donors.

Allogeneic hematopoietic stem cell transplantation (HSCT) with reduced-intensity conditioning (RIC) offers a curative option for patients with hematologic malignancies who are unable to undergo myeloablative conditioning, but its success is limited by high rates of relapse. Several studies have suggested a role for T cell doses in peripheral blood stem cell grafts in RIC HSCT. Because T cell dose is typically not known until after the collection, and apheresis blood volume is easily modifiable, we hypothesized that higher donor apheresis blood volumes would improve transplantation outcomes through an effect on graft composition. Thus, we analyzed the relationships between apheresis volume, graft composition, and transplantation outcomes in 142 consecutive patients undergoing unrelated donor allogeneic RIC HSCT. We found that apheresis volume ≥15 L was associated with a significantly decreased risk of relapse (adjusted hazard ratio [aHR], .48; 95% confidence interval [CI], .28 to .84]; P = .01) and improved relapse-free survival (aHR, .56; 95% CI, .35 to .89; P = .02) and overall survival (aHR, .55; 95% CI, .34 to .91; P = .02). A high apheresis volume was not associated with increased rates of acute or chronic graft-versus-host disease. These results demonstrate that an apheresis volume of at least 15 L is independently predictive of improved transplantation outcomes after RIC allogeneic HSCT.

Critical updates in the 7th edition of the American Society for Apheresis guidelines.

The 7th edition of the American Society for Apheresis (ASFA) guidelines was composed by an international physicians committee, and includes 14 new diseases, and 2 new indications for diseases described in the former guidelines. Several indications have either changed names or were excluded from this edition. The guidelines are developed after taking into account documented evidence, either supporting or negating use of apheresis technology in the treatment of diseases. Based on this evidence, the committee revises, updates and includes or excludes disease entities/indications in the guidelines. This article describes the revisions to the 7th edition of the ASFA guidelines, in a comprehensive manner.

Exploring donor and product factors and their impact on red cell post-transfusion outcomes.

The impact of donor characteristics, red cell age, and red cell processing methods on recipient outcomes is an emerging area of research. Knowledge generated from exploring this transfusion continuum has the potential to change the way donors are selected and how donations are processed and stored with important clinical and operational impact. Recently, donor characteristics including age, gender, donation frequency, genetics, and ethnicity have been shown to affect product quality and possibly recipient outcomes. The structural, biochemical and immunological changes that occur with red cell storage appear to not cause harm to blood recipients after 14 randomized clinical trials. However, both in vitro and clinical data are now beginning to question the safety of blood stored for a shorter duration. Whole blood filtration, a method of blood processing, has been linked to inferior recipient outcomes when compared to red cell filtration. Collectively, this emerging body of literature suggests that pre-transfusion parameters impact product quality and recipient outcomes and that no 2 units of red cells are quite the same. This review will summarize both the pre-clinical and clinical studies evaluating these associations.

Manufacture of Autologous CD34+ Selected Grafts in the NIAID-Sponsored HALT-MS and SCOT Multicenter Clinical Trials for Autoimmune Diseases.

To ensure comparable grafts for autologous hematopoietic cell transplantation (HCT) in the National Institute of Allergy and Infectious Diseases-sponsored Investigational New Drug protocols for multiple sclerosis (HALT-MS) and systemic sclerosis (SCOT), a Drug Master File approach to control manufacture was implemented, including a common Master Production Batch Record and site-specific standard operating procedures with "Critical Elements." We assessed comparability of flow cytometry and controlled rate cryopreservation among sites and stability of cryopreserved grafts using hematopoietic progenitor cells (HPCs) from healthy donors. Hematopoietic Progenitor Cells, Apheresis-CD34+ Enriched, for Autologous Use (Auto-CD34+HPC) graft specifications included ≥70% viable CD34+ cells before cryopreservation. For the 2 protocols, 110 apheresis collections were performed; 121 lots of Auto-CD34+HPC were cryopreserved, and 107 of these (88.4%) met release criteria. Grafts were infused at a median of 25 days (range, 17 to 68) post-apheresis for HALT-MS (n = 24), and 25 days (range, 14 to 78) for SCOT (n = 33). Subjects received precryopreservation doses of a median 5.1 × 106 viable CD34+ cells/kg (range, 3.9 to 12.8) for HALT-MS and 5.6 × 106 viable CD34+ cells/kg (range, 2.6 to 10.2) for SCOT. Recovery of granulocytes occurred at a median of 11 days (range, 9 to 15) post-HCT for HALT-MS and 10 days (range, 8 to 12) for SCOT, independent of CD34+ cell dose. Subjects received their last platelet transfusion at a median of 9 days (range, 6 to 16) for HALT-MS and 8 days (range, 6 to 23) for SCOT; higher CD34+/kg doses were associated with faster platelet recovery. Stability testing of cryopreserved healthy donor CD34+ HPCs over 6 months of vapor phase liquid nitrogen storage demonstrated consistent 69% to 73% recovery of viable CD34+ cells. Manufacturing of Auto-CD34+HPC for the HALT-MS and SCOT protocols was comparable across all sites and supportive for timely recovery of granulocytes and platelets.

Multicenter study to evaluate a new enumeration method for hematopoietic stem cell collection management.

BACKGROUND: CD34 flow cytometry is the gold standard for stem cell enumeration in peripheral blood at the mobilization stage and in the final apheresis product. The new stem cell mode of the Sysmex XN Series analyzer enumerates an immature cell population in the white progenitor and pathological cell (WPC) channel, based on the cell size, internal cellular complexity, and fluorescence intensity. STUDY DESIGN AND METHODS: In this multicenter study we analyzed 147 peripheral blood samples, 22 samples during collection of stem cells, and 45 samples from the apheresis product of 18 healthy allogeneic donors and 84 autologous patients. RESULTS: In this multicenter study we demonstrate that the XN stem cell enumeration method correlates well with viable CD34+ cells determined by flow cytometry during the stem cell mobilization phase to determine apheresis start time, during apheresis for real-time monitoring and adjustment, and for quality control of the final stem cell harvest. CONCLUSION: Our data show that there is an improvement in the correlation of XN stem cells and CD34+ cells in the peripheral blood during stem cell mobilization as well as in stem cell harvests compared to SE or XE Series analyzers. The XN stem cell enumeration method has a number of advantages compared to CD34 flow cytometry: it is fast, simple, reproducible, and less expensive. CE marking for the European market has been obtained, making the stem cell count on the XN analyzer a reportable clinical variable.

Barriers to the Implementation of Lipoprotein Apheresis in Canada.

This article details the effectiveness of using lipoprotein apheresis (LA) rather than plasmapheresis in patients with homozygous familial hypercholesterolemia (HoFH), using results from the first HoFH pediatric patient treated with LA in Ontario. We further detail the barriers involved in adhering to international guidelines by implementing this as a first-line treatment for this condition in Ontario, and the potential savings that would be gained with treating the remaining HoFH patients in this province with LA. A primary barrier has been the division of responsibility that exists in Canada, where the delivery of medical services and the delivery of blood products are separated, artificially discounting the price of plasmapheresis and making it seem like the less expensive option. We would like to implement LA as a first-line therapy, to not only improve patient quality of life and outcomes, but to also to potentially save our federal and provincial governments' taxpayer money.

Prevention of cardiovascular complications in patients with Lp(a)-hyperlipoproteinemia and progressive cardiovascular disease by long-term lipoprotein apheresis according to German national guidelines.

Lipoprotein(a) (Lp(a)) is an independent cardiovascular risk factor playing a causal role for atherosclerotic cardiovascular disease (CVD). Lipoprotein apheresis (LA) is a safe well-tolerated outpatient treatment to lower LDL-C and Lp(a) by 60-70%, and is the ultimate escalating therapeutic option in patients with hyperlipoproteinemias (HLP) involving LDL particles. Major therapeutic effect of LA is preventing cardiovascular events. Lp(a)-HLP associated with progressive CVD has been approved as indication for regular LA in Germany since 2008. The Pro(a)LiFe-study investigated with a prospective multicenter design the long-term preventive effect of LA on incidence rates of cardiovascular events prospectively over a period of 5 years in 170 consecutive patients who commenced regular LA. During a median period of 4.7 years of the pre-LA period, Lp(a) associated progressive CVD became apparent. Apolipoprotein(a) (apo(a)) isoforms and polymorphisms at the apo(a) gene (LPA) were analyzed to assess hypothetical clinical correlations. 154 patients (90.6%) completed 5­years follow-up. Significant decline of the mean annual major adverse cardiac event (MACE) rate was observed from 0.41 ± 0.45 two years prior to regular LA to 0.06 ± 0.11 during 5 years with regular LA (p < 0.0001). 95.3% of patients expressed at least one small apo(a) isoform. Calculation of isoform specific concentrations allowed to confirm the equivalence of 60 mg/dl or 120 nmol/l as Lp(a) thresholds of the German LA guideline. Results of 5 years prospective follow-up confirmed that LA has a lasting effect on prevention of cardiovascular events in patients with Lp(a)-HLP and afore progressive CVD.

Apheresis for collection of Ebola convalescent plasma in Liberia.

PURPOSE: This report describes initiation of apheresis capability in Liberia, Africa to support a clinical trial of convalescent plasma therapy for Ebola Virus Disease. METHODS: A bloodmobile was outfitted in the United States as a four-bed apheresis unit with capabilities including pathogen reduction, electronic blood establishment computer system, designated areas for donor counseling and laboratory testing, and onboard electrical power generation. After air transport to Liberia, the bloodmobile was positioned at ELWA Hospital, Monrovia, and connected to the hospital's power grid. Liberian staff were trained to conduct donor screening, which included questionnaire and onsite blood typing and transfusion transmitted infection (TTI) testing, and plasma collection and processing. RESULTS: The bloodmobile was operational within 3 weeks after arrival of the advance team. Of 101 donors who passed the pre-screening questionnaire, 32 were deferred. Twenty-eight of ninty-nine tested survivors were deferred for positive transfusion transmitted infection (TTI) tests; twenty-one were positive for hepatitis B, hepatitis C, or human immunodeficiency virus. The majority of donors had type O blood; all but one were Rh positive. Forty-three survivors donated at least once; eighty-nine apheresis attempts resulted in eighty-one successful collections. CONCLUSIONS: Apheresis capability was emergently established in Liberia to support an efficacy trial of Ebola Convalescent Plasma. Extensive cooperation among multinational team members, engineers, logisticians, and blood safety technical personnel at the operational site was required to surmount challenges to execution posed by logistical factors. The high proportion of positive TTI tests supported the use of a pathogen reduction system to enhance product safety. J. Clin. Apheresis 32:175-181, 2017. © 2016 Wiley Periodicals, Inc.

An alternative mini buffy coat preparation method for adult patients with extracorporeal photopheresis contraindications.

BACKGROUND: Extracorporeal photopheresis (ECP) is an important cell-based therapy for various diseases but is limited to patients eligible for apheresis. We developed an alternative mini buffy coat (BC) preparation method using the Spectra Optia® apheresis system and compared its efficacy of white blood cell (WBC) recovery with the standard mini BC preparation method already established for pediatric patients. METHODS: Whole blood (450 ± 45 mL) samples were collected from 30 randomly selected healthy volunteer blood donors and divided into two groups. In the first group, WBCs were separated with a fully automated separator device (Compomat G4® ). In the second group, BCs were separated with the bone marrow processing program of the Spectra Optia apheresis system. RESULTS: There were no significant differences in total leukocyte counts per product between the two groups. In contrast, lymphocyte counts per product were significantly higher (P < 0.001) in BCs separated from apheresis. CONCLUSION: Our novel technique resulted in similar WBC yields but higher lymphocyte yields than the standard mini BC preparation method. This method can serve as an alternative to WBC collection in conventional ECP for adult patients with apheresis contraindications. J. Clin. Apheresis 32:12-15, 2017. © 2016 Wiley Periodicals, Inc.