Pub Date : 2023-01-01DOI: 10.1177/26348535231207051
Jan Hartmann, Joshua Penrod, Mark Becker
{"title":"In Memoriam: Dr Marilyn Rosa-Bray—A Legacy of Service to Health and Humanity","authors":"Jan Hartmann, Joshua Penrod, Mark Becker","doi":"10.1177/26348535231207051","DOIUrl":"https://doi.org/10.1177/26348535231207051","url":null,"abstract":"","PeriodicalId":29816,"journal":{"name":"Plasmatology","volume":"100 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136202951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.1177/26348535231169459
Ugochi Ebinama, Hina Khan, Vinita Akula, Adan Rios
Primary non-Hodgkin's lymphoma of the bone is an unusual presentation of Hodgkin's lymphoma, with primary cranial vault lymphoma (PCVL) being the rarest of bone lymphomas. We describe a case of an immunocompetent elderly patient with new onset gait imbalance and cognitive delays. Brain imaging showed a large extra-axial mass with osseous invasion. An initial misdiagnosis of meningioma led to delays in management. Further work up included a brain magnetic resonance image showing a large right transcalvarial parietal mass. The mass was surgically removed, and pathology revealed B-cell lymphoma with low-grade features thus establishing the diagnosis of PCVL. Management included subtotal resection of the tumor followed by adjuvant radiation therapy. The patient has achieved a durable response for over a year. Meningioma and PCVL have similar imaging and clinical presentations. This case report addresses differing features of the tumors and explores therapeutic options for management of PCVL.
{"title":"Primary Cranial Vault Lymphoma Misdiagnosed as Atypical Meningioma: A Case Report","authors":"Ugochi Ebinama, Hina Khan, Vinita Akula, Adan Rios","doi":"10.1177/26348535231169459","DOIUrl":"https://doi.org/10.1177/26348535231169459","url":null,"abstract":"Primary non-Hodgkin's lymphoma of the bone is an unusual presentation of Hodgkin's lymphoma, with primary cranial vault lymphoma (PCVL) being the rarest of bone lymphomas. We describe a case of an immunocompetent elderly patient with new onset gait imbalance and cognitive delays. Brain imaging showed a large extra-axial mass with osseous invasion. An initial misdiagnosis of meningioma led to delays in management. Further work up included a brain magnetic resonance image showing a large right transcalvarial parietal mass. The mass was surgically removed, and pathology revealed B-cell lymphoma with low-grade features thus establishing the diagnosis of PCVL. Management included subtotal resection of the tumor followed by adjuvant radiation therapy. The patient has achieved a durable response for over a year. Meningioma and PCVL have similar imaging and clinical presentations. This case report addresses differing features of the tumors and explores therapeutic options for management of PCVL.","PeriodicalId":29816,"journal":{"name":"Plasmatology","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135651037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.1177/26348535231202681
Francisco Belda, Oscar Mora, Monica Lopez-Martinez, Nerea Torres, Ana Vivanco, Silvia Marfil, Edwards Pradenas, Marta Massanella, Julià Blanco, Rebecca Christie, Michael Crowley
Vaccines are an important tool in combating the COVID-19 pandemic. Two mRNA vaccines (mRNA-1273 and BNT-162b2) and an adenovirus vector vaccine (Ad26.COV2.S) were among the first vaccines to be approved by global regulatory authorities. The aim of this observational study was to characterize the levels and time course of the generation of anti-SARS-CoV-2 spike protein antibodies after vaccination with 3 different vaccines and the neutralizing activity of these antibodies. Seroconversion panels were generated from blood samples collected before and after vaccination with 3 COVID-19 vaccines: mRNA-1273, BNT-162b2, and Ad26.COV2.S. The seroconversion panels were tested for antibody activity by chemiluminescent immunoassay or enzyme-linked immunosorbent assay (ELISA), and 1 panel was tested for neutralization activity in a pseudovirus assay. Participants positive for anti-SARS-CoV-2 antibodies before vaccination (18.6%) had a higher response to the first dose than participants who tested negative. For 2-dose vaccines, older participants showed a lower response to the first dose than younger participants. All participants showed positive responses after the second vaccine. For the adenovirus vector vaccine, 2 participants did not generate antibody responses after vaccination. Four participants were negative at 2 weeks but positive at 2 months. Pseudovirus neutralization showed good correlation with antibody activity (correlation coefficient = 0.78, P < .0001). Antibody responses in participants over 45 years old tended to be less robust. Participants that had been infected with SARS-CoV-2 and had antibodies prior to vaccination showed a more robust response to initial vaccination. Older participants (>45 years) showed less robust responses to both types of vaccine. All participants receiving full mRNA vaccination showed positive antibody responses. Some participants receiving the adenovirus vaccine did not respond. Antibody responses correlated well with neutralization activity. Seroconversion panels can be useful in the development of antibody assays and in investigating their effectiveness against new SARS-CoV-2 variants.
{"title":"Demonstration of Antibodies Against SARS-CoV-2, Neutralizing or Binding, in Seroconversion Panels After mRNA-1273, BNT-162b2, and Ad26.COV2.S Vaccine Administration","authors":"Francisco Belda, Oscar Mora, Monica Lopez-Martinez, Nerea Torres, Ana Vivanco, Silvia Marfil, Edwards Pradenas, Marta Massanella, Julià Blanco, Rebecca Christie, Michael Crowley","doi":"10.1177/26348535231202681","DOIUrl":"https://doi.org/10.1177/26348535231202681","url":null,"abstract":"Vaccines are an important tool in combating the COVID-19 pandemic. Two mRNA vaccines (mRNA-1273 and BNT-162b2) and an adenovirus vector vaccine (Ad26.COV2.S) were among the first vaccines to be approved by global regulatory authorities. The aim of this observational study was to characterize the levels and time course of the generation of anti-SARS-CoV-2 spike protein antibodies after vaccination with 3 different vaccines and the neutralizing activity of these antibodies. Seroconversion panels were generated from blood samples collected before and after vaccination with 3 COVID-19 vaccines: mRNA-1273, BNT-162b2, and Ad26.COV2.S. The seroconversion panels were tested for antibody activity by chemiluminescent immunoassay or enzyme-linked immunosorbent assay (ELISA), and 1 panel was tested for neutralization activity in a pseudovirus assay. Participants positive for anti-SARS-CoV-2 antibodies before vaccination (18.6%) had a higher response to the first dose than participants who tested negative. For 2-dose vaccines, older participants showed a lower response to the first dose than younger participants. All participants showed positive responses after the second vaccine. For the adenovirus vector vaccine, 2 participants did not generate antibody responses after vaccination. Four participants were negative at 2 weeks but positive at 2 months. Pseudovirus neutralization showed good correlation with antibody activity (correlation coefficient = 0.78, P < .0001). Antibody responses in participants over 45 years old tended to be less robust. Participants that had been infected with SARS-CoV-2 and had antibodies prior to vaccination showed a more robust response to initial vaccination. Older participants (>45 years) showed less robust responses to both types of vaccine. All participants receiving full mRNA vaccination showed positive antibody responses. Some participants receiving the adenovirus vaccine did not respond. Antibody responses correlated well with neutralization activity. Seroconversion panels can be useful in the development of antibody assays and in investigating their effectiveness against new SARS-CoV-2 variants.","PeriodicalId":29816,"journal":{"name":"Plasmatology","volume":"57 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135699525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.1177/26348535221129221
M. Rosa-Bray, M. Bounpheng, Charlene Wisdom, T. Gierman, Mark Becker, K. Crookston
Background The COVID-19 pandemic highlighted plasma as a strategic resource with continually increasing demand. Demographic data for plasma donors are limited compared with blood donors. Increased information regarding pre-pandemic donor demographics may serve as a baseline for evaluation of post-pandemic practices. OBJECTIVES This study asked the question, “What were the demographics of source plasma donors in the US compared to the general population and how did these change over a five-year period preceding the pandemic?” STUDY DESIGN Donor demographic data were retrospectively analyzed for the years 2014, 2016 and 2018 from a network of US plasma centers. METHODS Routine demographic data obtained prior to source plasma collection from all plasma donors at Grifols US centers were retrospectively analyzed. Donor screening and eligibility requirements were standardized across all donor sites and met all donor eligibility requirements (Code of Federal Regulations: 21 CFR part 600). During each calendar year, only data from the first donation in that year were included with each cohort year. RESULTS This study included 1,303,049 unique donors. Donors were predominantly young adult males, although females increased from 37.4% to 41.6%. Caucasians constituted the highest proportion, followed by African American and Hispanic donors. Demographics were generally stable, but the 2018 cohort and the US population exhibited significantly different age, race/ethnicity, and sex profiles. Of 2014 donors, 9.0% returned in all three years studied (2014-2016-2018), with a higher return rate of 16.0% observed for donors returning in just two of the years (2014-2016). Multiyear donors were predominantly male and African American. CONCLUSION US plasma donor demographics over a five-year period (2014-2018) showed generally consistent characteristics but differed from the general US population. Multiyear donors were demographically distinct from single-year donors. These data serve as a snapshot of the US source plasma donor base prior to the COVID-19 pandemic.
{"title":"A Retrospective Study Establishing Pre-Pandemic Demographic Baselines for United States Source Plasma Donors","authors":"M. Rosa-Bray, M. Bounpheng, Charlene Wisdom, T. Gierman, Mark Becker, K. Crookston","doi":"10.1177/26348535221129221","DOIUrl":"https://doi.org/10.1177/26348535221129221","url":null,"abstract":"Background The COVID-19 pandemic highlighted plasma as a strategic resource with continually increasing demand. Demographic data for plasma donors are limited compared with blood donors. Increased information regarding pre-pandemic donor demographics may serve as a baseline for evaluation of post-pandemic practices. OBJECTIVES This study asked the question, “What were the demographics of source plasma donors in the US compared to the general population and how did these change over a five-year period preceding the pandemic?” STUDY DESIGN Donor demographic data were retrospectively analyzed for the years 2014, 2016 and 2018 from a network of US plasma centers. METHODS Routine demographic data obtained prior to source plasma collection from all plasma donors at Grifols US centers were retrospectively analyzed. Donor screening and eligibility requirements were standardized across all donor sites and met all donor eligibility requirements (Code of Federal Regulations: 21 CFR part 600). During each calendar year, only data from the first donation in that year were included with each cohort year. RESULTS This study included 1,303,049 unique donors. Donors were predominantly young adult males, although females increased from 37.4% to 41.6%. Caucasians constituted the highest proportion, followed by African American and Hispanic donors. Demographics were generally stable, but the 2018 cohort and the US population exhibited significantly different age, race/ethnicity, and sex profiles. Of 2014 donors, 9.0% returned in all three years studied (2014-2016-2018), with a higher return rate of 16.0% observed for donors returning in just two of the years (2014-2016). Multiyear donors were predominantly male and African American. CONCLUSION US plasma donor demographics over a five-year period (2014-2018) showed generally consistent characteristics but differed from the general US population. Multiyear donors were demographically distinct from single-year donors. These data serve as a snapshot of the US source plasma donor base prior to the COVID-19 pandemic.","PeriodicalId":29816,"journal":{"name":"Plasmatology","volume":"51 1","pages":""},"PeriodicalIF":0.3,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73905924","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.1177/26348535221130289
Eniola Enifeni, A. Ogbenna, A. O. Daramola, A. Adewoyin, O. Olatunya, E. Temiye
Background and Objectives Sickle cell anemia (SCA) is associated with recurrent acute inflammatory processes. These inflammatory processes could lead to elevation of Factor VIII and Von Willebrand Factor levels, thereby increasing the risk of stroke in SCA children. This study aims to determine vWF/FVIII levels in children with SCA and their association with abnormal transcranial Doppler (TCD). Subjects and Methods This study enrolled 75 children, including 24 SCA cases with normal TCD, 27 SCA cases with abnormal TCD, and 24 Hb AA controls, all aged between 2 and 16 years. Transcranial Doppler (TCD) ultrasound was performed to measure the cerebral blood velocity. Venous blood drawn from each participant was used to determine the levels of von Willebrand Factor Antigen (vWF: Ag) and Factor VIII (FVIII) and the complete blood count (CBC). Relationships among the measured parameters were determined using SPSS version 25. Statistical significance was set at P < .05. Results FVIII and vWF levels were significantly higher among children with SCA compared to the Hb AA controls (P < .001). Although SCA patients with abnormal TCD tended to have higher levels of FVIII and vWF, this result did not attain statistical significance (P > .05). There was a moderate negative correlation between the left middle cerebral artery and FVIII, (r = −0.332; P = .017). Children with SCA showing an abnormal TCD velocity had significantly higher platelet count compared to those with normal TCD (P = .018). Conclusion Children with SCA have elevated levels of FVIII and vWF, and an abnormal TCD velocity is associated with elevated platelet count.
{"title":"Relationships Between Transcranial Doppler Velocity, Von Willebrand Factor, Factor VIII, and Hematological Parameters in Children with Sickle Cell Anemia: A Comparative Cross-Sectional Study","authors":"Eniola Enifeni, A. Ogbenna, A. O. Daramola, A. Adewoyin, O. Olatunya, E. Temiye","doi":"10.1177/26348535221130289","DOIUrl":"https://doi.org/10.1177/26348535221130289","url":null,"abstract":"Background and Objectives Sickle cell anemia (SCA) is associated with recurrent acute inflammatory processes. These inflammatory processes could lead to elevation of Factor VIII and Von Willebrand Factor levels, thereby increasing the risk of stroke in SCA children. This study aims to determine vWF/FVIII levels in children with SCA and their association with abnormal transcranial Doppler (TCD). Subjects and Methods This study enrolled 75 children, including 24 SCA cases with normal TCD, 27 SCA cases with abnormal TCD, and 24 Hb AA controls, all aged between 2 and 16 years. Transcranial Doppler (TCD) ultrasound was performed to measure the cerebral blood velocity. Venous blood drawn from each participant was used to determine the levels of von Willebrand Factor Antigen (vWF: Ag) and Factor VIII (FVIII) and the complete blood count (CBC). Relationships among the measured parameters were determined using SPSS version 25. Statistical significance was set at P < .05. Results FVIII and vWF levels were significantly higher among children with SCA compared to the Hb AA controls (P < .001). Although SCA patients with abnormal TCD tended to have higher levels of FVIII and vWF, this result did not attain statistical significance (P > .05). There was a moderate negative correlation between the left middle cerebral artery and FVIII, (r = −0.332; P = .017). Children with SCA showing an abnormal TCD velocity had significantly higher platelet count compared to those with normal TCD (P = .018). Conclusion Children with SCA have elevated levels of FVIII and vWF, and an abnormal TCD velocity is associated with elevated platelet count.","PeriodicalId":29816,"journal":{"name":"Plasmatology","volume":"1 1","pages":""},"PeriodicalIF":0.3,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76513312","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.1177/26348535221107531
Rafael-Emmanuel Cuevas, J. Cid, Sara Carbonell-Ordeig, A. Álvarez-Larrán, M. Lozano
Asparaginase (ASP), a chemotherapy treatment used for acute lymphoblastic leukemia (ALL), is known to provoke severe hypertriglyceridemia (HTG). We report the case of a woman with a history of obesity and diabetes mellitus who developed severe HTG (up to 7305 mg/dL) after receiving a pegylated form of ASP for ALL. The patient was treated with one plasma exchange without incident via peripheral veins using 5% albumin as a replacement solution. Her triglycerides were reduced to 485 mg/dL. A single plasma exchange was an efficient, fast, and safe way to decrease triglycerides concentration in plasma.
{"title":"Severe Hypertriglyceridemia Associated with Pegylated Asparaginase Successfully Treated with Plasma Exchange","authors":"Rafael-Emmanuel Cuevas, J. Cid, Sara Carbonell-Ordeig, A. Álvarez-Larrán, M. Lozano","doi":"10.1177/26348535221107531","DOIUrl":"https://doi.org/10.1177/26348535221107531","url":null,"abstract":"Asparaginase (ASP), a chemotherapy treatment used for acute lymphoblastic leukemia (ALL), is known to provoke severe hypertriglyceridemia (HTG). We report the case of a woman with a history of obesity and diabetes mellitus who developed severe HTG (up to 7305 mg/dL) after receiving a pegylated form of ASP for ALL. The patient was treated with one plasma exchange without incident via peripheral veins using 5% albumin as a replacement solution. Her triglycerides were reduced to 485 mg/dL. A single plasma exchange was an efficient, fast, and safe way to decrease triglycerides concentration in plasma.","PeriodicalId":29816,"journal":{"name":"Plasmatology","volume":"39 1","pages":""},"PeriodicalIF":0.3,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85265043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.1177/26348535221131685
G. Escolar, A. Páez, J. Cid
Conventional therapeutic plasma exchange (TPE) is aimed at removing pathological agents from circulation using a medical device which separates out plasma from other components of blood. Usually, 1.0 to 1.5 plasma volumes are removed and replaced with a replacement solution. There is strong clinical evidence for the effectiveness of TPE in a wide spectrum of diseases, such as thrombotic thrombocytopenic purpura, severe acute inflammatory demyelinating polyneuropathy, and Guillain-Barré syndrome, among others. However, therapeutic approaches using lower plasma exchange volumes (LVPE) suggest some degree of effectiveness in a number of pathological conditions, although generally with low level of clinical evidence: hematology disorders (autoimmune hemolytic anemia), neuroimmunological diseases (Guillain-Barré syndrome, neuromyelitis optica, myasthenia gravis, multiple sclerosis), pulmonary disorders, liver failure, dermatology (pemphigus) and metabolic diseases (porphyria, cholesterol). Further or newer studies are needed to confirm LVPE as an alternative to TPE for such groups of pathologies. While plasma volume removed for TPE ranges 3-4.5 L per procedure, for LVPE ranges from 350 mL to 2 L (frequency and duration vary depending on the pathology treated). In the case of Alzheimer‘s disease (AD), the AMBAR trial recently investigated a combined sequence of intensive TPE with human albumin replacement followed by a maintenance phase LVPE (650-880 mL of plasma removed, similar to a plasma donation). The treatment slowed the decline or stabilized the disease symptoms. The AMBAR approach could justify investigating the use of LVPE in chronic conditions where plasma exchange strategies have proven successful.
{"title":"Conventional Therapeutic Plasma Exchange Versus Low Volume Plasma Exchange in Chronic Pathologies: Potential Benefit in Alzheimer’s Disease","authors":"G. Escolar, A. Páez, J. Cid","doi":"10.1177/26348535221131685","DOIUrl":"https://doi.org/10.1177/26348535221131685","url":null,"abstract":"Conventional therapeutic plasma exchange (TPE) is aimed at removing pathological agents from circulation using a medical device which separates out plasma from other components of blood. Usually, 1.0 to 1.5 plasma volumes are removed and replaced with a replacement solution. There is strong clinical evidence for the effectiveness of TPE in a wide spectrum of diseases, such as thrombotic thrombocytopenic purpura, severe acute inflammatory demyelinating polyneuropathy, and Guillain-Barré syndrome, among others. However, therapeutic approaches using lower plasma exchange volumes (LVPE) suggest some degree of effectiveness in a number of pathological conditions, although generally with low level of clinical evidence: hematology disorders (autoimmune hemolytic anemia), neuroimmunological diseases (Guillain-Barré syndrome, neuromyelitis optica, myasthenia gravis, multiple sclerosis), pulmonary disorders, liver failure, dermatology (pemphigus) and metabolic diseases (porphyria, cholesterol). Further or newer studies are needed to confirm LVPE as an alternative to TPE for such groups of pathologies. While plasma volume removed for TPE ranges 3-4.5 L per procedure, for LVPE ranges from 350 mL to 2 L (frequency and duration vary depending on the pathology treated). In the case of Alzheimer‘s disease (AD), the AMBAR trial recently investigated a combined sequence of intensive TPE with human albumin replacement followed by a maintenance phase LVPE (650-880 mL of plasma removed, similar to a plasma donation). The treatment slowed the decline or stabilized the disease symptoms. The AMBAR approach could justify investigating the use of LVPE in chronic conditions where plasma exchange strategies have proven successful.","PeriodicalId":29816,"journal":{"name":"Plasmatology","volume":"71 1","pages":""},"PeriodicalIF":0.3,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89396832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.1177/26348535221114460
D. Obat, M. Stevanovic, Catherine L. Andrews, E. Mondou, Z. Szczepiorkowski, M. Barceló, M. K. Woodward, N. Ribó, Wei Liang, E. Stommel
Background: Neuroinflammation is being increasingly recognized as a key factor in the pathogenesis of amyotrophic lateral sclerosis (ALS). A therapeutic approach for ALS using plasma exchange with albumin replacement (PE-A) has been proposed to remove antibody complexes, inflammatory mediators, and toxins to decrease neuronal damage caused by inflammation. Methods: In this pilot study, 15 patients underwent 24 weeks of PE-A with 5% albumin and their revised ALS Functional Rating Scale (ALSFRS-R) scores and Forced Vital Capacity (FVC) were tracked for 48 weeks to evaluate the efficacy of PE-A as a therapy for ALS. Results: There was a statistically significant decline of ALSFRS-R scores as well as FVC (%) throughout the study. A post hoc comparison with clinically matched control patients showed no statistically significant difference. Likewise, no significant differences were found when the rate of ALSFRS-R decline in the PE-A-treated patients was compared to the European Medicines Agency (EMA) guideline estimate of a −1 point/month decrease in untreated patients. However, 50% of the PE-A-treated patients showed a slow rate of decline of < −0.8 points/month. PE was safe and well tolerated in ALS patients. Conclusion: In conclusion, results of this study indicated that PE-A performed in this manner was safe but showed a considerable heterogeneity in the response to treatment when it comes to slowing the ALS deterioration, with no overall clinical benefit. Further investigation focused on the characterization of ALS patients suitable for PE-A therapy is warranted. Registration: ClinicalTrials.gov ID: NCT02872142.
{"title":"Efficacy and Safety of Plasma Exchange with Albumin Replacement as a Therapy for Amyotrophic Lateral Sclerosis","authors":"D. Obat, M. Stevanovic, Catherine L. Andrews, E. Mondou, Z. Szczepiorkowski, M. Barceló, M. K. Woodward, N. Ribó, Wei Liang, E. Stommel","doi":"10.1177/26348535221114460","DOIUrl":"https://doi.org/10.1177/26348535221114460","url":null,"abstract":"Background: Neuroinflammation is being increasingly recognized as a key factor in the pathogenesis of amyotrophic lateral sclerosis (ALS). A therapeutic approach for ALS using plasma exchange with albumin replacement (PE-A) has been proposed to remove antibody complexes, inflammatory mediators, and toxins to decrease neuronal damage caused by inflammation. Methods: In this pilot study, 15 patients underwent 24 weeks of PE-A with 5% albumin and their revised ALS Functional Rating Scale (ALSFRS-R) scores and Forced Vital Capacity (FVC) were tracked for 48 weeks to evaluate the efficacy of PE-A as a therapy for ALS. Results: There was a statistically significant decline of ALSFRS-R scores as well as FVC (%) throughout the study. A post hoc comparison with clinically matched control patients showed no statistically significant difference. Likewise, no significant differences were found when the rate of ALSFRS-R decline in the PE-A-treated patients was compared to the European Medicines Agency (EMA) guideline estimate of a −1 point/month decrease in untreated patients. However, 50% of the PE-A-treated patients showed a slow rate of decline of < −0.8 points/month. PE was safe and well tolerated in ALS patients. Conclusion: In conclusion, results of this study indicated that PE-A performed in this manner was safe but showed a considerable heterogeneity in the response to treatment when it comes to slowing the ALS deterioration, with no overall clinical benefit. Further investigation focused on the characterization of ALS patients suitable for PE-A therapy is warranted. Registration: ClinicalTrials.gov ID: NCT02872142.","PeriodicalId":29816,"journal":{"name":"Plasmatology","volume":"86 1","pages":""},"PeriodicalIF":0.3,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80888532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.1177/26348535221107565
José Rivera, M. Lozano
Voluntary non-remunerated blood donation is well-established in many countries; however, this approach is under pressure to provide sufficient plasma for future needs. In this article we consider various aspects of plasma donation, including donor characteristics, health and safety issues, and motivating factors, including the potential role of incentives. The status of plasma donation in various European countries, and challenges associated with the COVID-19 pandemic are also discussed. Common motivators for plasma donors include the benefit that donated plasma provides for other people, the sense that helping others is in their nature, a sense of pride at undertaking a special task, and the desire to achieve donation goals. Motivations may differ between age groups and gender. Donating plasma is safe and adverse events are infrequent, with the most common being hypotensive/vasovagal events and phlebotomy events. The main reasons plasma donors discontinue are socioeconomic, relating to the time required and conflicts with work and other commitments. When persuading donors to convert from whole blood to plasma donation, face-to-face requests are more successful than leaflets or telephone/email requests, and clear information addressing health and safety concerns is needed. However, telephone/email communication can be helpful for encouraging plasma donors to return for future donations or to donate more frequently. There is ongoing debate about non-remunerated versus remunerated plasma donation. Remuneration may be an incentive for some individuals, whereas it may deter people who have a strong altruistic drive. It has been suggested that a combination of paid and unpaid donation systems could cover a wider range of potential donors. Most European countries currently have non-remunerated donor systems, but a few do allow monetary compensation.
{"title":"Plasmapheresis and Plasma Donation: Challenges in the Blood/Plasma Supply Chain","authors":"José Rivera, M. Lozano","doi":"10.1177/26348535221107565","DOIUrl":"https://doi.org/10.1177/26348535221107565","url":null,"abstract":"Voluntary non-remunerated blood donation is well-established in many countries; however, this approach is under pressure to provide sufficient plasma for future needs. In this article we consider various aspects of plasma donation, including donor characteristics, health and safety issues, and motivating factors, including the potential role of incentives. The status of plasma donation in various European countries, and challenges associated with the COVID-19 pandemic are also discussed. Common motivators for plasma donors include the benefit that donated plasma provides for other people, the sense that helping others is in their nature, a sense of pride at undertaking a special task, and the desire to achieve donation goals. Motivations may differ between age groups and gender. Donating plasma is safe and adverse events are infrequent, with the most common being hypotensive/vasovagal events and phlebotomy events. The main reasons plasma donors discontinue are socioeconomic, relating to the time required and conflicts with work and other commitments. When persuading donors to convert from whole blood to plasma donation, face-to-face requests are more successful than leaflets or telephone/email requests, and clear information addressing health and safety concerns is needed. However, telephone/email communication can be helpful for encouraging plasma donors to return for future donations or to donate more frequently. There is ongoing debate about non-remunerated versus remunerated plasma donation. Remuneration may be an incentive for some individuals, whereas it may deter people who have a strong altruistic drive. It has been suggested that a combination of paid and unpaid donation systems could cover a wider range of potential donors. Most European countries currently have non-remunerated donor systems, but a few do allow monetary compensation.","PeriodicalId":29816,"journal":{"name":"Plasmatology","volume":"98 1","pages":""},"PeriodicalIF":0.3,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90607990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.1177/26348535221129232
F. Belda, Oscar Mora, Rebecca Christie, M. Crowley
BACKGROUND Vaccines have emerged as a crucial tool in combatting the COVID-19 pandemic particularly those based on SARS-CoV-2 S-protein mRNA. A crucial aspect of vaccine efficacy is the duration of antibody responses. In this study, a seroconversion panel was created to assess antibody responses to the mRNA-1273 vaccine over time (6.5 months). METHODS Blood samples collected from 15 healthy adult participants prior to and up to 6.5 months after vaccination with the mRNA-1273 vaccine (Moderna). Serum from these blood samples were analyzed for anti-SARS-CoV-2 antibody activity by chemiluminescent immunoassay. RESULTS The immunoassay results showed that one participant was positive for anti-SARS-CoV-2 antibodies prior to vaccination indicating a prior infection. All participants showed a positive antibody response after the first vaccination. Highest antibody responses were seen after the second dose (41-45 days from the first dose). Subsequent samples collected at 69-75 days, 130-135 days, and 221-229 days after the first vaccination showed positive responses but a biphasic decline in the levels of anti-SARS-CoV-2 antibodies. CONCLUSIONS Declining antibody levels in these participants support the use of booster vaccination to increase antibody levels 4-6 months after the initial vaccine series and continued monitoring to assess the durability of COVID-19 vaccine responses. These results are in agreement with other studies showing antibody persistence but declining the antibody levels in the months after immunization with mRNA-based vaccines. The seroconversion panels described here could be useful in the development of antibody assays and in the assessment of the duration of antibody responses to vaccine boosters compared to the initial vaccine series. This panel could also be used to assess antibody activity against emerging viral variants (eg B.1.1.529 [Omicron] and its subvariants) compared to earlier variants.
{"title":"A Longitudinal Seroconversion Panel Shows Anti-SARS-CoV-2 Antibody Levels up to 6.5 Months After Vaccination with mRNA-1273 (Moderna)","authors":"F. Belda, Oscar Mora, Rebecca Christie, M. Crowley","doi":"10.1177/26348535221129232","DOIUrl":"https://doi.org/10.1177/26348535221129232","url":null,"abstract":"BACKGROUND Vaccines have emerged as a crucial tool in combatting the COVID-19 pandemic particularly those based on SARS-CoV-2 S-protein mRNA. A crucial aspect of vaccine efficacy is the duration of antibody responses. In this study, a seroconversion panel was created to assess antibody responses to the mRNA-1273 vaccine over time (6.5 months). METHODS Blood samples collected from 15 healthy adult participants prior to and up to 6.5 months after vaccination with the mRNA-1273 vaccine (Moderna). Serum from these blood samples were analyzed for anti-SARS-CoV-2 antibody activity by chemiluminescent immunoassay. RESULTS The immunoassay results showed that one participant was positive for anti-SARS-CoV-2 antibodies prior to vaccination indicating a prior infection. All participants showed a positive antibody response after the first vaccination. Highest antibody responses were seen after the second dose (41-45 days from the first dose). Subsequent samples collected at 69-75 days, 130-135 days, and 221-229 days after the first vaccination showed positive responses but a biphasic decline in the levels of anti-SARS-CoV-2 antibodies. CONCLUSIONS Declining antibody levels in these participants support the use of booster vaccination to increase antibody levels 4-6 months after the initial vaccine series and continued monitoring to assess the durability of COVID-19 vaccine responses. These results are in agreement with other studies showing antibody persistence but declining the antibody levels in the months after immunization with mRNA-based vaccines. The seroconversion panels described here could be useful in the development of antibody assays and in the assessment of the duration of antibody responses to vaccine boosters compared to the initial vaccine series. This panel could also be used to assess antibody activity against emerging viral variants (eg B.1.1.529 [Omicron] and its subvariants) compared to earlier variants.","PeriodicalId":29816,"journal":{"name":"Plasmatology","volume":"2 1","pages":""},"PeriodicalIF":0.3,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91140968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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