24 results on '"Shaw, Bronwen E."'
Search Results
2. Changes in Hematopoietic Cell Transplantation Practices in Response to COVID-19: A Survey from the Worldwide Network for Blood & Marrow Transplantation.
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Worel N, Shaw BE, Aljurf M, Koh M, Seber A, Weisdorf D, Schwartz J, Galeano S, Kodera Y, Eldridge PW, Hashmi S, Atsuta Y, Szer J, Saber W, Niederwieser D, and Greinix HT
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- Algorithms, Allografts, Bone Marrow Transplantation trends, COVID-19 diagnosis, COVID-19 prevention & control, COVID-19 Testing methods, COVID-19 Testing statistics & numerical data, Cryopreservation methods, Donor Selection standards, Global Health, Health Care Surveys, Hematopoietic Stem Cell Mobilization statistics & numerical data, Hematopoietic Stem Cell Transplantation trends, Practice Patterns, Physicians' statistics & numerical data, Procedures and Techniques Utilization statistics & numerical data, Tissue Preservation methods, Transplantation, Autologous, Unrelated Donors statistics & numerical data, Bone Marrow Transplantation statistics & numerical data, COVID-19 epidemiology, Hematopoietic Stem Cell Transplantation statistics & numerical data, Pandemics, SARS-CoV-2
- Abstract
SARS-CoV-2 has spread rapidly worldwide, but the full impact of the COVID-19 pandemic on the field of hematopoietic cell transplantation (HCT) remains unknown. To understand this better, an 18-item online survey was disseminated by the Worldwide Network for Blood & Marrow Transplantation with questions exploring SARS-CoV-2 testing algorithms, mobilization, and cryopreservation strategies and COVID-19 infections in allogeneic related and autologous hematopoietic progenitor cell (HPC) donors. The aim of this survey was to assess the impact of the outbreak on policies relating to HPC mobilization, collection, and processing with respect to changes in daily routine. A total of 91 individual responses from distinct centers in 6 continents were available for analysis. In these centers, the majority (72%) of allogeneic related and autologous donors are routinely tested for SARS-CoV-2 before HPC collection, and 80% of centers implement cryopreservation of allogeneic HPC grafts before commencing conditioning regimens in patients. Five related and 14 autologous donors who tested positive for COVID-19 did not experience any unexpected adverse events or reactions during growth factor administration (eg, hyperinflammatory syndrome). These data are limited by the small number of survey respondents but nonetheless suggest that centers are following the recommendations of appropriate scientific organizations and provide some preliminary data to suggest areas of further study., (Copyright © 2020 The American Society for Transplantation and Cellular Therapy. All rights reserved.)
- Published
- 2021
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3. Graft Cryopreservation Does Not Impact Overall Survival after Allogeneic Hematopoietic Cell Transplantation Using Post-Transplantation Cyclophosphamide for Graft-versus-Host Disease Prophylaxis.
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Hamadani M, Zhang MJ, Tang XY, Fei M, Brunstein C, Chhabra S, D'Souza A, Milano F, Phelan R, Saber W, Shaw BE, Weisdorf D, Devine SM, and Horowitz MM
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- Adult, Aged, Aged, 80 and over, COVID-19, Cohort Studies, Cyclophosphamide therapeutic use, Female, Graft vs Host Disease immunology, Graft vs Host Disease mortality, Graft vs Host Disease pathology, Histocompatibility Testing, Humans, Leukemia immunology, Leukemia mortality, Leukemia pathology, Lymphoma immunology, Lymphoma mortality, Lymphoma pathology, Male, Middle Aged, Myelodysplastic Syndromes immunology, Myelodysplastic Syndromes mortality, Myelodysplastic Syndromes pathology, Pandemics, Siblings, Survival Analysis, Transplantation Conditioning methods, Transplantation, Homologous, United States epidemiology, Unrelated Donors supply & distribution, Bone Marrow Transplantation methods, Coronavirus Infections epidemiology, Cryopreservation methods, Graft vs Host Disease prevention & control, Hematopoietic Stem Cell Transplantation methods, Leukemia therapy, Lymphoma therapy, Myelodysplastic Syndromes therapy, Pneumonia, Viral epidemiology
- Abstract
The COVID-19 pandemic has created significant barriers to timely donor evaluation, cell collection, and graft transport for allogeneic hematopoietic stem cell transplantation (allo-HCT). To ensure availability of donor cells on the scheduled date of infusion, many sites now collect cryopreserved grafts before the start of pretransplantation conditioning. Post-transplantation cyclophosphamide (ptCY) is an increasingly used approach for graft-versus-host disease (GVHD) prophylaxis, but the impact of graft cryopreservation on the outcomes of allo-HCT using ptCY is not known. Using the Center for International Blood and Marrow Transplant Research (CIBMTR) database, we compared the outcomes of HCT using cryopreserved versus fresh grafts in patients undergoing HCT for hematologic malignancy with ptCY. We analyzed 274 patients with hematologic malignancy undergoing allo-HCT between 2013 and 2018 with cryopreserved grafts and ptCY. Eighteen patients received bone marrow grafts and 256 received peripheral blood stem cell grafts. These patients were matched for age, graft type, disease risk index (DRI), and propensity score with 1080 patients who underwent allo-HCT with fresh grafts. The propensity score, which is an assessment of the likelihood of receiving a fresh graft versus a cryopreserved graft, was calculated using logistic regression to account for the following: disease histology, Karnofsky Performance Score (KPS), HCT Comorbidity Index, conditioning regimen intensity, donor type, and recipient race. The primary endpoint was overall survival (OS). Secondary endpoints included acute and chronic graft-versus-host disease (GVHD), non-relapse mortality (NRM), relapse/progression and disease-free survival (DFS). Because of multiple comparisons, only P values <.01 were considered statistically significant. The 2 cohorts (cryopreserved and fresh) were similar in terms of patient age, KPS, diagnosis, DRI, HCT-CI, donor/graft source, and conditioning intensity. One-year probabilities of OS were 71.1% (95% confidence interval [CI], 68.3% to 73.8%) with fresh grafts and 70.3% (95% CI, 64.6% to 75.7%) with cryopreserved grafts (P = .81). Corresponding probabilities of OS at 2 years were 60.6% (95% CI, 57.3% to 63.8%) and 58.7% (95% CI, 51.9% to 65.4%) (P = .62). In matched-pair regression analysis, graft cryopreservation was not associated with a significantly higher risk of mortality (hazard ratio [HR] for cryopreserved versus fresh, 1.05; 95% CI, .86 to 1.29; P = .60). Similarly, rates of neutrophil recovery (HR, .91; 95% CI, .80 to 1.02; P = .12), platelet recovery (HR, .88; 95% CI, .78 to 1.00; P = .05), grade III-IV acute GVHD (HR, .78; 95% CI, .50 to 1.22; P = .27), NRM (HR, 1.16; 95% CI, .86 to 1.55; P = .32) and relapse/progression (HR, 1.21; 95% CI, .97 to 1.50; P = .09) were similar with cryopreserved grafts versus fresh grafts. There were somewhat lower rates of chronic GVHD (HR, 78; 95% CI, .61 to .99; P = .04) and DFS (HR for treatment failure, 1.19; 95% CI, 1.01 to 1.29; P = .04) with graft cryopreservation that were of marginal statistical significance after adjusting for multiple comparisons. Overall, our data indicate that graft cryopreservation does not significantly delay hematopoietic recovery, increase the risk of acute GVHD or NRM, or decrease OS after allo-HCT using ptCY., (Copyright © 2020 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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4. Hematopoietic Cell Transplantation with Cryopreserved Grafts for Severe Aplastic Anemia.
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Eapen M, Zhang MJ, Tang XY, Lee SJ, Fei MW, Wang HL, Hebert KM, Arora M, Chhabra S, Devine SM, Hamadani M, D'Souza A, Pasquini MC, Phelan R, Rizzo JD, Saber W, Shaw BE, Weisdorf DJ, and Horowitz MM
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- Acute Disease, Adolescent, Adult, Aged, Anemia, Aplastic immunology, Anemia, Aplastic mortality, Anemia, Aplastic pathology, COVID-19, Child, Child, Preschool, Female, Graft Rejection immunology, Graft Rejection mortality, Graft vs Host Disease immunology, Graft vs Host Disease mortality, Histocompatibility Testing, Humans, Male, Middle Aged, Pandemics, Retrospective Studies, Siblings, Survival Analysis, Transplantation Conditioning methods, United States epidemiology, Unrelated Donors, Anemia, Aplastic therapy, Bone Marrow Transplantation methods, Coronavirus Infections epidemiology, Cryopreservation methods, Graft Rejection pathology, Graft vs Host Disease pathology, Peripheral Blood Stem Cell Transplantation methods, Pneumonia, Viral epidemiology
- Abstract
With the COVID-19 pandemic and the ensuing barriers to the collection and transport of donor cells, it is often necessary to collect and cryopreserve grafts before initiation of transplantation conditioning. The effect on transplantation outcomes in nonmalignant disease is unknown. This analysis examined the effect of cryopreservation of related and unrelated donor grafts for transplantation for severe aplastic anemia in the United States during 2013 to 2019. Included are 52 recipients of cryopreserved grafts who were matched for age, donor type, and graft type to 194 recipients who received noncryopreserved grafts. Marginal Cox regression models were built to study the effect of cryopreservation and other risk factors associated with outcomes. We recorded higher 1-year rates of graft failure (hazard ratio [HR], 2.26; 95% confidence interval, 1.17 to 4.35; P = .01) and of 1-year overall mortality (HR, 3.13; 95% CI, 1.60 to 6.11; P = .0008) after transplantation of cryopreserved compared with noncryopreserved grafts, with adjustment for sex, performance score, comorbidity, cytomegalovirus serostatus, and ABO blood group match. The incidence of acute and chronic graft-versus-host disease did not differ between the 2 groups. Adjusted probabilities of 1-year survival were 73% (95% CI, 60% to 84%) in the cryopreserved graft group and 91% (95% CI, 86% to 94%) in the noncryopreserved graft group. These data support the use of noncryopreserved grafts whenever possible in patients with severe aplastic anemia., (Copyright © 2020 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)
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- 2020
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5. "Worldwide Network for Blood & Marrow Transplantation (WBMT) special article, challenges facing emerging alternate donor registries".
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Aljurf M, Weisdorf D, Alfraih F, Szer J, Müller C, Confer D, Hashmi S, Kröger N, Shaw BE, Greinix H, Kharfan-Dabaja MA, Foeken L, Seber A, Ahmed S, El-Jawahri A, Al-Awwami M, Atsuta Y, Pasquini M, Hanbali A, Alzahrani H, Okamoto S, Gluckman E, Mohty M, Kodera Y, Horowitz M, Niederwieser D, and El Fakih R
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- Humans, Bone Marrow Transplantation methods, Registries statistics & numerical data, Tissue Donors statistics & numerical data
- Abstract
Hematopoietic cell transplantation (HCT) activity is increasing at an unprecedented pace with > 50,000 allogeneic transplants occurring annually worldwide. Establishing a functional HCT donor registry can be very challenging with respect to ethnicities, financial, technical, and geopolitical issues. Extensive planning steps are essential to overcome the expected challenges while establishing the registry, and to maintain its functionality. A few strategies can help move past those challenges and push the development of such registries forward. Authorities involved in HCT donor registry establishment will have to balance the advantages and costs of such a project and accommodate the emerging alternatives such as cord blood or related haploidentical transplants. Miscalculations and incomplete understanding of the various aspects of the process can have tremendous impact on the optimization of a HCT donor registry especially in developing countries. Herein we present some challenges in establishing such a registry and present potential solutions.
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- 2019
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6. A Conceptual Framework and Key Research Questions in Educational Needs of Blood and Marrow Transplantation Patients, Caregivers, and Families.
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Schoemans HM, Finn L, Foster J, Roche-Green A, Bevans M, Kullberg S, Lee E, Sargeant C, Schatz BA, Scheeler K, Shaw BE, Shereck E, Murphy EA, Burns LJ, and Schmit-Pokorny K
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- Female, Humans, Male, Bone Marrow, Bone Marrow Transplantation, Caregivers, Family, Patient Education as Topic, Patient Outcome Assessment
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Patient, caregiver, and family education and support was 1 of 6 key areas of interest identified by the National Marrow Donor Program/Be The Match 2-year project to prioritize patient-centered outcomes research (PCOR) goals for the blood and marrow transplantation (BMT) community. PCOR focuses on research to help patients and their caregivers make informed decisions about health care. Therefore, each area of interest was assigned to a working group with broad representation, including patients, caregivers, and clinicians. Each working group was charged with identifying gaps in knowledge and making priority recommendations for critical research to fill those gaps. The report from this working group presents a conceptual framework to address gaps in knowledge regarding patient and caregiver education in BMT and recommendations for priority research questions on this topic., (Copyright © 2019. Published by Elsevier Inc.)
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- 2019
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7. Comparison of Patient-Reported Outcomes in 5-Year Survivors Who Received Bone Marrow vs Peripheral Blood Unrelated Donor Transplantation: Long-term Follow-up of a Randomized Clinical Trial.
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Lee SJ, Logan B, Westervelt P, Cutler C, Woolfrey A, Khan SP, Waller EK, Maziarz RT, Wu J, Shaw BE, Confer D, Horowitz MM, and Anasetti C
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- Adolescent, Adult, Aged, Bone Marrow immunology, Female, Follow-Up Studies, Hematologic Neoplasms immunology, Hematologic Neoplasms pathology, Humans, Male, Middle Aged, Survival Analysis, Unrelated Donors, Bone Marrow Transplantation methods, Hematologic Neoplasms therapy, Hematopoietic Stem Cell Transplantation methods
- Abstract
Importance: Bone marrow or peripheral blood from unrelated donors may be used for hematopoietic cell transplantation. Information about the relative success of transplantation with these 2 graft sources would help physicians and patients choose between them., Objective: To compare patient-reported outcomes between patients randomized to receive 1 of 2 graft types for unrelated donor transplantation., Design, Setting, and Participants: This follow-up of a randomized clinical trial included English- or Spanish-speaking patients 16 years or older participating in a multicenter randomized clinical trial of unrelated donor bone marrow (BM) vs peripheral blood (PB) (N = 551) in hematopoietic cell transplantation for hematologic neoplasms. Patient-reported outcomes were collected from patients at enrollment and 0.5, 1, 2, and 5 years after transplantation., Interventions: Unrelated donor BM or PB hematopoietic cell transplantation., Main Outcomes and Measures: Functional Assessment of Cancer Therapy-Bone Marrow Transplant, Mental Health Inventory, occupational functioning, Lee Chronic Graft-vs-Host Disease Symptom Scale., Results: At 5 years after transplantation, 102 BM and 93 PB participants were alive and eligible for assessment (age ≥40 years or older: 104 [53.5%] male: 101 [51.8%]). The mean (SE) Mental Health Inventory Psychological Well-Being scores (78.9 [1.7] vs 72.2 [1.9]; P = .01; higher better) and Lee chronic graft-vs-host disease symptom scores (13.1 [1.5] vs 19.3 [1.6]; P = .004; lower better) were significantly better for BM recipients, adjusting for baseline scores and missing data. Recipients of BM were also more likely to be working full or part-time than recipients of PB (odds ratio, 1.5; 95% CI, 1.2-2.0; P = .002), adjusting for work status before transplantation. With a median follow-up of 73 months (range, 30-121 months) for survivors, no differences in survival (40% vs 39%; P = .84), relapse (32% vs 29%; P = .47), or treatment-related mortality (29% vs 32%; P = .44) between BM and PB were observed., Conclusions and Relevance: Recipients of unrelated donor BM had better psychological well-being, less burdensome chronic GVHD symptoms, and were more likely to return to work than recipients of PB at 5 years after transplantation. Bone marrow should be the standard of care for these types of transplant procedures., Trial Registration: clinicaltrials.gov Identifier: NCT00075816.
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- 2016
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8. Harvests from bone marrow donors who weigh less than their recipients are associated with a significantly increased probability of a suboptimal harvest yield.
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Anthias C, Billen A, Arkwright R, Szydlo RM, Madrigal JA, and Shaw BE
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- Adolescent, Adult, Bone Marrow, Bone Marrow Cells cytology, Bone Marrow Transplantation standards, Cell Count, Female, Humans, Male, Middle Aged, Probability, Tissue and Organ Harvesting standards, Young Adult, Body Weight, Bone Marrow Transplantation methods, Tissue Donors, Tissue and Organ Harvesting methods
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Background: Previous studies have demonstrated the importance of bone marrow (BM) harvest yield in determining transplant outcomes, but little is known regarding donor and procedure variables associated with achievement of an optimal yield. We hypothesized that donor demographics and variables relating to the procedure were likely to impact the yield (total nucleated cells [TNCs]/kg recipient weight) and quality (TNCs/mL) of the harvest., Study Design and Methods: To test our hypothesis, BM harvests of 110 consecutive unrelated donors were evaluated. The relationship between donor or procedure characteristics and the BM harvest yield was examined., Results: The relationship between donor and recipient weight significantly influenced the harvest yield; only 14% of BM harvests from donors who weighed less than their recipient achieved a TNC count of more than 4 × 10(8) /kg compared to 56% of harvests from donors heavier than their recipient (p = 0.001). Higher-volume harvests were significantly less likely to achieve an optimal yield than lower-volume harvests (32% vs. 78%; p = 0.007), and higher-volume harvests contained significantly fewer TNCs/mL, indicating peripheral blood contamination. BM harvest quality also varied significantly between collection centers adding to recent concerns regarding maintenance of BM harvest expertise within the transplant community., Conclusion: Since the relationship between donor and recipient weight has a critical influence yield, we recommend prioritizing this secondary donor characteristic when selecting from multiple well-matched donors. Given the declining number of requests for BM harvests, it is crucial that systems are developed to train operators and ensure expertise in this procedure is retained., (© 2016 AABB.)
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- 2016
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9. Analysis of the Effect of Race, Socioeconomic Status, and Center Size on Unrelated National Marrow Donor Program Donor Outcomes: Donor Toxicities Are More Common at Low-Volume Bone Marrow Collection Centers.
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Shaw BE, Logan BR, Kiefer DM, Chitphakdithai P, Pedersen TL, Abdel-Azim H, Abidi MH, Akpek G, Diaz MA, Artz AS, Dandoy C, Gajewski JL, Hematti P, Kamble RT, Kasow KA, Lazarus HM, Liesveld JL, Majhail NS, O'Donnell PV, Olsson RF, Savani BN, Schears RM, Stroncek DF, Switzer GE, Williams EP, Wingard JR, Wirk BM, Confer DL, and Pulsipher MA
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- Adolescent, Adult, Anesthesia adverse effects, Anesthesia methods, Blood Cell Count, Body Mass Index, Cytomegalovirus Infections epidemiology, Female, Filgrastim adverse effects, Humans, Income statistics & numerical data, Male, Middle Aged, Pain epidemiology, Pain etiology, Young Adult, Bone Marrow Transplantation, Hospitals, High-Volume statistics & numerical data, Hospitals, Low-Volume statistics & numerical data, Peripheral Blood Stem Cell Transplantation, Racial Groups, Social Class, Tissue Donors statistics & numerical data, Tissue and Organ Harvesting adverse effects
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Previous studies have shown that risks of collection-related pain and symptoms are associated with sex, body mass index, and age in unrelated donors undergoing collection at National Marrow Donor Program centers. We hypothesized that other important factors (race, socioeconomic status [SES], and number of procedures at the collection center) might affect symptoms in donors. We assessed outcomes in 2726 bone marrow (BM) and 6768 peripheral blood stem cell (PBSC) donors collected between 2004 and 2009. Pain/symptoms are reported as maximum levels over mobilization and collection (PBSC) or within 2 days of collection (BM) and at 1 week after collection. For PBSC donors, race and center volumes were not associated with differences in pain/symptoms at any time. PBSC donors with high SES levels reported higher maximum symptom levels 1 week after donation (P = .017). For BM donors, black males reported significantly higher levels of pain (OR, 1.90; CI, 1.14 to 3.19; P = .015). No differences were noted by SES group. BM donors from low-volume centers reported more toxicity (OR, 2.09; CI, 1.26 to 3.46; P = .006). In conclusion, race and SES have a minimal effect on donation-associated symptoms. However, donors from centers performing ≤ 1 BM collection every 2 months have more symptoms after BM donation. Approaches should be developed by registries and low-volume centers to address this issue., (Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.)
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- 2015
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10. Subsequent donation requests among 2472 unrelated hematopoietic progenitor cell donors are associated with bone marrow harvest.
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Lown RN, Tulpule S, Russell NH, Craddock CF, Roest R, Madrigal JA, and Shaw BE
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- Adolescent, Adult, Aged, Bone Marrow Transplantation methods, Child, Child, Preschool, Female, Graft Rejection diagnosis, Graft Rejection prevention & control, Hematopoietic Stem Cell Transplantation methods, Humans, Infant, Infant, Newborn, Male, Middle Aged, Retrospective Studies, Time Factors, Unrelated Donors supply & distribution, Young Adult, Bone Marrow Transplantation ethics, Hematopoietic Stem Cell Transplantation ethics, Unrelated Donors ethics
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Approximately 1 in 20 unrelated donors are asked to make a second donation of hematopoietic progenitor cells, the majority for the same patient. Anthony Nolan undertook a study of subsequent hematopoietic progenitor cell donations made by its donors from 2005 to 2011, with the aims of predicting those donors more likely to be called for a second donation, assessing rates of serious adverse reactions and examining harvest yields. This was not a study of factors predictive of second allografts. During the study period 2591 donations were made, of which 120 (4.6%) were subsequent donations. The median time between donations was 179 days (range, 21-4016). Indications for a second allogeneic transplant included primary graft failure (11.7%), secondary graft failure (53.2%), relapse (30.6%) and others (1.8%). On multivariate analysis, bone marrow harvest at first donation was associated with subsequent donation requests (odds ratio 2.00, P=0.001). The rate of serious adverse reactions in donors making a subsequent donation appeared greater than the rate in those making a first donation (relative risk=3.29, P=0.005). Harvest yields per kilogram recipient body weight were equivalent between donations, although females appeared to have a lower yield at the subsequent donation. Knowledge of these factors will help unrelated donor registries to counsel their donors.
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- 2013
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11. Acute toxicities of unrelated bone marrow versus peripheral blood stem cell donation: results of a prospective trial from the National Marrow Donor Program.
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Pulsipher MA, Chitphakdithai P, Logan BR, Shaw BE, Wingard JR, Lazarus HM, Waller EK, Seftel M, Stroncek DF, Lopez AM, Maharaj D, Hematti P, O'Donnell PV, Loren AW, Leitman SF, Anderlini P, Goldstein SC, Levine JE, Navarro WH, Miller JP, and Confer DL
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- Adolescent, Adult, Anesthesia adverse effects, Blood Cell Count, Convalescence, Exanthema epidemiology, Exanthema etiology, Fatigue epidemiology, Female, Fever epidemiology, Filgrastim, Gastrointestinal Diseases epidemiology, Gastrointestinal Diseases etiology, Granulocyte Colony-Stimulating Factor pharmacology, Hematopoietic Stem Cell Mobilization methods, Hospitalization statistics & numerical data, Humans, Male, Middle Aged, Obesity epidemiology, Pain epidemiology, Prospective Studies, Recombinant Proteins adverse effects, Recombinant Proteins pharmacology, Syncope epidemiology, Syncope etiology, Tissue and Organ Harvesting methods, United States, Young Adult, Blood Component Removal adverse effects, Blood Donors, Bone Marrow Transplantation, Fatigue etiology, Fever etiology, Granulocyte Colony-Stimulating Factor adverse effects, Hematopoietic Stem Cell Mobilization adverse effects, Pain etiology, Peripheral Blood Stem Cell Transplantation, Tissue Donors, Tissue and Organ Harvesting adverse effects
- Abstract
Although peripheral blood stem cells (PBSCs) have replaced bone marrow (BM) as the most common unrelated donor progenitor cell product collected, a direct comparison of concurrent PBSC versus BM donation experiences has not been performed. We report a prospective study of 2726 BM and 6768 PBSC donors who underwent collection from 2004 to 2009. Pain and toxicities were assessed at baseline, during G-CSF administration, on the day of collection, within 48 hours of donation, and weekly until full recovery. Peak levels of pain and toxicities did not differ between the 2 donation processes for most donors. Among obese donors, PBSC donors were at increased risk of grade 2 to 4 pain as well as grade 2 to 4 toxicities during the pericollection period. In contrast, BM donors were more likely to experience grade 2 to 4 toxicities at 1 week and pain at 1 week and 1 month after the procedure. BM donors experienced slower recovery, with 3% still not fully recovered at 24 weeks, whereas 100% of PBSC donors had recovered. Other factors associated with toxicity included obesity, increasing age, and female sex. In summary, this study provides extensive detail regarding individualized risk patterns of PBSC versus BM donation toxicity, suggesting donor profiles that can be targeted with interventions to minimize toxicity.
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- 2013
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12. Diagnosis and management of acute graft-versus-host disease.
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Dignan FL, Clark A, Amrolia P, Cornish J, Jackson G, Mahendra P, Scarisbrick JJ, Taylor PC, Hadzic N, Shaw BE, and Potter MN
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- Acute Disease, Bone Marrow Transplantation adverse effects, Disease Management, Graft vs Host Disease etiology, Humans, Stem Cell Transplantation adverse effects, Bone Marrow Transplantation methods, Graft vs Host Disease diagnosis, Graft vs Host Disease therapy, Stem Cell Transplantation methods
- Abstract
A joint working group established by the Haemato-oncology subgroup of the British Committee for Standards in Haematology (BCSH) and the British Society for Bone Marrow Transplantation (BSBMT) has reviewed the available literature and made recommendations for the diagnosis and management of acute graft-versus-host disease. This guideline includes recommendations for the diagnosis and grading of acute graft-versus-host disease as well as primary treatment and options for patients with steroid-refractory disease. The goal of treatment should be effective control of graft-versus-host disease while minimizing risk of toxicity and relapse., (© 2012 Blackwell Publishing Ltd.)
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- 2012
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13. Diagnosis and management of chronic graft-versus-host disease.
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Dignan FL, Amrolia P, Clark A, Cornish J, Jackson G, Mahendra P, Scarisbrick JJ, Taylor PC, Shaw BE, and Potter MN
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- Bone Marrow Transplantation adverse effects, Chronic Disease, Disease Management, Graft vs Host Disease etiology, Humans, Stem Cell Transplantation adverse effects, Bone Marrow Transplantation methods, Graft vs Host Disease diagnosis, Graft vs Host Disease therapy, Stem Cell Transplantation methods
- Abstract
A joint working group established by the Haemato-oncology subgroup of the British Committee for Standards in Haematology (BCSH) and the British Society for Bone Marrow Transplantation (BSBMT) has reviewed the available literature and made recommendations for the diagnosis and management of chronic graft-versus-host disease (GvHD). This guideline includes recommendations for the diagnosis and staging of chronic GvHD as well as primary treatment and options for patients with steroid-refractory disease. The goal of treatment should be the effective control of GvHD while minimizing the risk of toxicity and relapse., (© 2012 Blackwell Publishing Ltd.)
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- 2012
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14. Higher Risks of Toxicity and Incomplete Recovery in 13- to 17-Year-Old Females after Marrow Donation: RDSafe Peds Results.
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Pulsipher, Michael A, Logan, Brent R, Kiefer, Deidre M, Chitphakdithai, Pintip, Riches, Marcie L, Rizzo, J Douglas, Anderlini, Paolo, Leitman, Susan F, Varni, James W, Kobusingye, Hati, Besser, RaeAnne M, Miller, John P, Drexler, Rebecca J, Abdel-Mageed, Aly, Ahmed, Ibrahim A, Ball, Edward D, Bolwell, Brian J, Bunin, Nancy J, Cheerva, Alexandra, Delgado, David C, Dvorak, Christopher C, Gillio, Alfred P, Hahn, Theresa E, Hale, Gregory A, Haight, Ann E, Hayes-Lattin, Brandon M, Kasow, Kimberly A, Linenberger, Michael, Magalhaes-Silverman, Margarida, Mori, Shahram, Prasad, Vinod K, Quigg, Troy C, Sahdev, Indira, Schriber, Jeffrey R, Shenoy, Shalini, Tse, William T, Yanik, Gregory A, Navarro, Willis H, Horowitz, Mary M, Confer, Dennis L, Shaw, Bronwen E, and Switzer, Galen E
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Humans ,Pain ,Tissue and Organ Harvesting ,Bone Marrow Transplantation ,Transplantation ,Homologous ,Age Factors ,Sex Factors ,Time Factors ,Adolescent ,Tissue Donors ,Female ,Male ,BM collection toxicities ,Donor safety ,PBSC collection toxicities ,Stem cell transplantation ,Transplantation ,Chronic Pain ,Neurosciences ,Pediatric ,Clinical Research ,Stem Cell Research ,Pain Research ,Clinical Trials and Supportive Activities ,Prevention ,Immunology ,Clinical Sciences - Abstract
Although donation of bone marrow (BM) or peripheral blood stem cells (PBSCs) from children to family members undergoing allogeneic transplantation are well-established procedures, studies detailing levels of pain, symptoms, and long-term recovery are lacking. To address this lack, we prospectively enrolled 294 donors age 20% of females and males age 13 to 17 years do not return to baseline pain levels by 1 year after BM donation. Studies aimed at decreasing symptoms and improving recovery in older children are warranted.
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- 2019
15. BMT CTN State of the Science Symposium 2021: Looking Forward as the Network Celebrates its 20(th) Year
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Heslop, Helen E, Stadtmauer, Edward A, Levine, John E, Ballen, Karen K, Chen, Yi-Bin, DeZern, Amy E, Eapen, Mary, Hamadani, Mehdi, Hamilton, Betty K, Hari, Parameswaran, Jones, Richard J, Logan, Brent R, Kean, Leslie S, Leifer, Eric S, Locke, Frederick L, Maziarz, Richard T, Nemecek, Eneida R, Pasquini, Marcelo, Phelan, Rachel, Riches, Marcie L, Shaw, Bronwen E, Walters, Mark C, Foley, Amy, Devine, Steven M, and Horowitz, Mary M
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Clinical Trials as Topic ,Hematopoietic Stem Cell Transplantation ,Humans ,Transplants ,Article ,Bone Marrow Transplantation - Abstract
In 2021 the BMT CTN held the 4th State of the Science Symposium where the deliberations of 11 committees concerning major topics pertinent to a particular disease, modality, or complication of transplant, as well as two committees to consider clinical trial design and inclusion, diversity, and access as cross-cutting themes were reviewed. This article summarizes the individual committee reports and their recommendations on the highest priority questions in hematopoietic stem cell transplant and cell therapy to address in multicenter trials.
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- 2021
16. An Analysis of the Effect of Race, Socioeconomic Status and Center Size on Unrelated NMDP Donor Outcomes: Donor Toxicities are More Common at Low Volume Bone Marrow Collection Centers
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Shaw, Bronwen E., Logan, Brent R., Kiefer, Deidre M., Chitphakdithai, Pintip, Pedersen, Tanya L., Abdel-Azim, Hisham, Abidi, Muneer H., Akpek, Gorgun, Diaz, Miguel A., Artz, Andrew S., Dandoy, Christopher, Gajewski, James L., Hematti, Peiman, Kamble, Rammurti T., Kasow, Kimberley A., Lazarus, Hillard M., Liesveld, Jane L., Majhail, Navneet S., O’Donnell, Paul V., Olsson, Richard F., Savani, Bipin N., Schears, Raquel M., Stroncek, David F., Switzer, Galen E., Williams, Eric P., Wingard, John R., Wirk, Baldeep M., Confer, Dennis L., and Pulsipher, Michael A.
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Adult ,Male ,Peripheral Blood Stem Cell Transplantation ,Hospitals, Low-Volume ,Adolescent ,Filgrastim ,Racial Groups ,Pain ,Middle Aged ,Article ,Tissue Donors ,Blood Cell Count ,Body Mass Index ,Young Adult ,Social Class ,Cytomegalovirus Infections ,Income ,Tissue and Organ Harvesting ,Humans ,Anesthesia ,Female ,Hospitals, High-Volume ,Bone Marrow Transplantation - Abstract
Previous studies have shown that risks of collection-related pain and symptoms are associated with sex, body mass index (BMI), and age in unrelated donors undergoing collection at National Marrow Donor Program (NMDP) centers. We hypothesized that other important factors (race, socioeconomic status (SES), and number of procedures at the collection center) might affect symptoms in donors. We assessed outcomes in 2,726 bone marrow (BM) and 6,768 peripheral blood stem cell (PBSC) donors collected between 2004 and 2009. Pain/symptoms are reported as maximum levels over mobilization and collection (PBSC) or within 2 days of collection (BM) and at 1 week after collection. For PBSC donors, race and center volumes were not associated with differences in pain/symptoms at any time. PBSC donors with high SES levels reported higher maximum symptom levels 1 week post donation (p=0.017). For BM donors, black males reported significantly higher levels of pain (OR=1.90, CI=1.14-3.19, p=0.015). No differences were noted by SES groups. BM donors from low volume centers reported more toxicity (OR=2.09, CI=1.26-3.46, p=0.006). In conclusion, race and SES have a minimal effect on donation associated symptoms. However, donors from centers performing ≤1 BM collection every 2 months have more symptoms following BM donation. Approaches should be developed by registries and low volume centers to address this issue.
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- 2015
17. Donor Experiences of Second Marrow or Peripheral Blood Stem Cell Collection Mirror the First, but CD34+ Yields Are Less.
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Stroncek, David F., Shaw, Bronwen E., Logan, Brent R., Kiefer, Deidre M., Savani, Bipin N., Anderlini, Paolo, Bredeson, Christopher N., Hematti, Peiman, Ganguly, Siddhartha, Diaz, Miguel Angel, Abdel-Azim, Hisham, Ahmed, Ibrahim, Maharaj, Dipnarine, Seftel, Matthew, Beitinjaneh, Amer, Seo, Sachiko, Yared, Jean A., Halter, Joerg, O'Donnell, Paul V., and Hale, Gregory A.
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ORGAN donation , *HEMATOPOIETIC stem cell transplantation , *BONE marrow transplantation , *HEMATOPOIETIC system - Abstract
Little is known about the experiences of individuals donating peripheral blood stem cells (PBSCs) or marrow for a second time. To study this, unrelated donors making a second donation through the National Marrow Donor Program between 2004 and 2013 were evaluated. Experiences of second-time donors giving marrow (n = 118: first donation was PBSC in 76 and marrow in 42) were compared with those making only 1 marrow donation (n = 5829). Experiences of second-time donors giving PBSCs (n = 602) (first donation was PBSCs in 362; marrow in 240) were compared to first-time PBSC donors (n = 16,095). For donors giving a second PBSC or marrow donation there were no significant differences in maximum skeletal pain, maximum symptoms measured by an established modified toxicity criteria, and recovery time compared with those who donated only once. Notably, the yield of marrow nucleated cells and PBSC CD34 + cells with second donations was less. As previously noted with single first-time donations, female (PBSCs and marrow) and obese donors (PBSCs) had higher skeletal pain and/or toxicity with a second donation. PBSC donors who experienced high levels of pain or toxicity with the first donation also experienced high levels of these symptoms with their second donation and slower recovery times. In conclusion, for most donors second donation experiences were similar to first donation experiences, but CD34 + yields were less. Knowledge of the donor's first experience and stem cell yields may help centers decide whether second donations are appropriate and institute measures to improve donor experiences. [ABSTRACT FROM AUTHOR]
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- 2018
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18. Transplantation Using Bone Marrow from a (very) HLA Mismatched Unrelated Donor in the Setting of Post-Transplant Cyclophosphamide Is Feasible and Expands Access to Underserved Minorities.
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Shaw, Bronwen E., Burns, Linda J., Logan, Brent, Jimenez-Jimenez, Antonio Martin, Khimani, Farhad, Shaffer, Brian C., Shah, Nirav N., Mussetter, Alisha, Tang, Xiao-Ying, McCarty, John M., Alavi, Asif, Farhadfar, Nosha, Jamieson, Katarzyna, Hardy, Nancy M., Choe, Hannah, Ambinder, Richard F., Anasetti, Claudio, Perales, Miguel, Howard, Alan, and Komanduri, Krishna V.
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BONE marrow transplantation , *CORD blood , *HUMAN herpesvirus-6 , *BK virus , *HEMATOLOGIC malignancies , *BONE marrow , *ALEMTUZUMAB - Abstract
Despite increasing donor options for allogeneic transplantation, including matched/mismatched related donors, matched unrelated donors and cord blood units, a proportion of patients do not find a donor. This is especially relevant in patients from racial/ethnic minorities. Post-transplant cyclophosphamide (PTCY) has successfully overcome barriers related to HLA-mismatching in the related donor setting. We hypothesized that transplantation with a mismatched unrelated donor (MMUD) using PTCY would be feasible and associated with high engraftment and acceptable GVHD incidence. We performed a prospective Phase II study of MMUD bone marrow (BM) transplantation with PTCY for patients with hematologic malignancies. Patients with a suitable HLA matched related or URD were excluded. Patients received a fresh BM graft, followed by PTCY on days +3, +4, Sirolimus/MMF starting on Day+5. Matching for 4-7/8 at HLA-A, -B, -C, and –DRB1 was permitted. We enrolled 80 patients (40 full intensity conditioning [FIC]; 40 reduced intensity conditioning [RIC]) at 11 transplant centers in the U.S. between Dec 2016 and March 2019. Regimen intensity was at the center's discretion. Characteristics are shown in Table 1. Importantly, 48% of patients were non-white/Hispanic, 55% had an HCT-CI >2 and 34% had a KPS of <90. 39% of donors were mismatched for >1 HLA allele, 59% were under 30. Overall survival and non-relapse mortality at 100 days were 92% and 5% in the FIC arm, and 90% and 7.5% in the RIC arm (Table 2). Neutrophil recovery was 98% in both arms, with no primary graft failure in the FIC arm, and 7.5% in the RIC arm. Peripheral blood donor chimerism was >75% at all timepoints. Acute GVHD grade III-IV at day 100 was relatively high at 25% in the FIC arm but very low at 2.6% in the RIC arm. Viral reactivations were high (Table 3). These early (day 100) results of our prospective study show high rates of engraftment with acceptable rates of GVHD in recipients of MMUD transplantation with PTCY, despite a high degree of HLA mismatch. An important finding is that ethnic minorities represent almost 50% of the study population, showing that this approach expands access to patients in need of potentially curative therapy. BK and HHV-6 virus reactivation/infection were common, the clinical significance of which requires further study. Understanding the risks for and impact of graft failure and acute GVHD is being studied as follow up continues. [ABSTRACT FROM AUTHOR]
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- 2020
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19. CD25 Blockade Delays Regulatory T Cell Reconstitution and Does Not Prevent Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation.
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Locke, Frederick L., Pidala, Joseph, Storer, Barry, Martin, Paul J., Pulsipher, Michael A., Chauncey, Thomas R., Jacobsen, Niels, Kröger, Nicolaus, Walker, Irwin, Light, Susan, Shaw, Bronwen E., Beato, Francisca, Laport, Ginna G., Nademanee, Auayporn, Keating, Armand, Socie, Gerard, and Anasetti, Claudio
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GRAFT versus host disease , *CD25 antigen , *T cells , *HEMATOPOIETIC stem cell transplantation , *BONE marrow transplantation , *MONOCLONAL antibodies - Abstract
Daclizumab, a humanized monoclonal antibody, binds CD25 and blocks formation of the IL-2 receptor on T cells. A study of daclizumab as acute graft-versus-host disease (GVHD) prophylaxis after unrelated bone marrow transplantation was conducted before the importance of CD25 + FOXP3 + regulatory T cells (Tregs) was recognized. Tregs can abrogate the onset of GVHD. The relation between Tregs and a graft-versus-malignancy effect is not fully understood. An international, multicenter, double-blind clinical trial randomized 210 adult or pediatric patients to receive 5 weekly doses of daclizumab at 0.3 mg/kg (n = 69) or 1.2 mg/kg (n = 76) or placebo (n = 65) after unrelated marrow transplantation for treatment of hematologic malignancies or severe aplastic anemia. The risk of acute GVHD did not differ among the groups ( P = .68). Long-term follow-up of clinical outcomes and correlative analysis of peripheral blood T cell phenotype suggested that the patients treated with daclizumab had an increased risk of chronic GVHD (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.0 to 2.3; P = .08) and a decreased risk of relapse (HR, 0.57; 95% CI, 0.3 to 1.0; P = .05), but similar survival (HR, 0.89; 95% CI, 0.6 to 1.3; P = .53). T cells from a subset of patients (n = 107) were analyzed by flow cytometry. Compared with placebo, treatment with daclizumab decreased the proportion of Tregs among CD4 T cells at days 11-35 and increased the proportion of central memory cells among CD4 T cells at 1 year. Prophylactic administration of daclizumab does not prevent acute GVHD, but may increase the risk of chronic GVHD and decrease the risk of relapse. By delaying Treg reconstitution and promoting immunologic memory, anti-CD25 therapy may augment alloreactivity and antitumor immunity. [ABSTRACT FROM AUTHOR]
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- 2017
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20. European Group for Blood and Marrow Transplantation Centers with FACT-JACIE Accreditation Have Significantly Better Compliance with Related Donor Care Standards.
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Anthias, Chloe, O'Donnell, Paul V., Kiefer, Deidre M., Yared, Jean, Norkin, Maxim, Anderlini, Paolo, Savani, Bipin N., Diaz, Miguel A., Bitan, Menachem, Halter, Joerg P., Logan, Brent R., Switzer, Galen E., Pulsipher, Michael A., Confer, Dennis L., and Shaw, Bronwen E.
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BONE marrow transplantation , *BLOOD donors , *MEDICAL care , *EUROPEANS , *MEDICAL centers , *HEALTH - Abstract
Previous studies have identified healthcare practices that may place undue pressure on related donors (RDs) of hematopoietic cell products and an increase in serious adverse events associated with morbidities in this population. As a result, specific requirements to safeguard RD health have been introduced to Foundation for the Accreditation of Cellular Therapy/The Joint Accreditation Committee ISCT and EBMT (FACT-JACIE) Standards, but the impact of accreditation on RD care has not previously been evaluated. A survey of transplant program directors of European Group for Blood and Marrow Transplantation member centers was conducted by the Donor Health and Safety Working Committee of the Center for International Blood and Marrow Transplant Research to test the hypothesis that RD care in FACT-JACIE accredited centers is more closely aligned with international consensus donor care recommendations than RD care delivered in centers without accreditation. Responses were received from 39% of 304 centers. Our results show that practice in accredited centers was much closer to recommended standards as compared with nonaccredited centers. Specifically, a higher percentage of accredited centers use eligibility criteria to assess RDs (93% versus 78%; P = .02), and a lower percentage have a single physician simultaneously responsible for an RD and their recipient (14% versus 35%; P = .008). In contrast, where regulatory standards do not exist, both accredited and nonaccredited centers fell short of accepted best practice. These results raise concerns that despite improvements in care, current practice can place undue pressure on donors and may increase the risk of donation-associated adverse events. We recommend measures to address these issues through enhancement of regulatory standards as well as national initiatives to standardize RD care. [ABSTRACT FROM AUTHOR]
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- 2016
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21. Determination of Eligibility in Related Pediatric Hematopoietic Cell Donors: Ethical and Clinical Considerations. Recommendations from a Working Group of the Worldwide Network for Blood and Marrow Transplantation Association.
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Bitan, Menachem, van Walraven, Suzanna M., Worel, Nina, Ball, Lynne M., Styczynski, Jan, Torrabadella, Marta, Witt, Volker, Shaw, Bronwen E., Seber, Adriana, Yabe, Hiromasa, Greinix, Hildegard T., Peters, Christina, Gluckman, Eliane, Rocha, Vanderson, Halter, Joerg, and Pulsipher, Michael A.
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HEMATOPOIETIC stem cells , *BONE marrow transplantation , *HOMOGRAFTS , *ORGAN donors , *WELL-being , *MEDICAL needs assessment - Abstract
Related donors for hematopoietic cell (HC) transplantation are a growing population in recent years because of expanding indications for allogeneic transplantation. The safety and welfare of the donor are major concerns for the transplantation community, especially for related sibling donors of young recipients who are children and, thus, not able to fully consent. Because donation of HC does not improve the donor's own physical health and carries a risk of side effects, careful assessment of medical risks specific to the individual donor, as well as consideration of ethical and legal aspects associated with donation from a child, must be considered. In addition, donor centers must balance the needs of both the donor and the recipient, understanding the inherent conflict parents may have as they can be overly focused on the very sick child receiving a transplant, rather than on the relatively less significant health or emotional problems that a sibling donor may have, which could impact risk with donation. Likewise, consideration must be made regarding the nature of the relationship of the sibling donor to the recipient and also aspects of performing research on pediatric HC donors. In this article, as members of the Donor Issues Committee of the Worldwide Network for Blood and Marrow Transplantation, we review key ethical concerns associated with pediatric donation and then give recommendations for screening potential child donors with underlying health conditions. These recommendations are aimed at protecting the physical and emotional well-being of childhood donors and arise out of the Third International Conference on Health and Safety of Donors sponsored by the Worldwide Network for Blood and Marrow Transplantation. [ABSTRACT FROM AUTHOR]
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- 2016
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22. Race and Ethnicity Influences Collection of Granulocyte Colony–Stimulating Factor–Mobilized Peripheral Blood Progenitor Cells from Unrelated Donors, a Center for International Blood and Marrow Transplant Research Analysis.
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Hsu, Jack W., Wingard, John R., Logan, Brent R., Chitphakdithai, Pintip, Akpek, Gorgun, Anderlini, Paolo, Artz, Andrew S., Bredeson, Chris, Goldstein, Steven, Hale, Gregory, Hematti, Peiman, Joshi, Sarita, Kamble, Rammurti T., Lazarus, Hillard M., O'Donnell, Paul V., Pulsipher, Michael A., Savani, Bipin N., Schears, Raquel M., Shaw, Bronwen E., and Confer, Dennis L.
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BONE marrow transplantation , *GRANULOCYTE colony stimulating factor receptor , *PROGENITOR cells , *ORGAN donors , *CD34 antigen , *RACISM in medicine , *MULTIVARIATE analysis - Abstract
Little information exists on the effect of race and ethnicity on collection of peripheral blood stem cells (PBSC) for allogeneic transplantation. We studied 10,776 donors from the National Marrow Donor Program who underwent PBSC collection from 2006 to 2012. Self-reported donor race/ethnic information included Caucasian, Hispanic, Black/African American (AA), Asian/Pacific Islander (API), and Native American (NA). All donors were mobilized with subcutaneous filgrastim at an approximate dose of 10 μg/kg/day for 5 days. Overall, AA donors had the highest median yields of mononuclear cells per liter and CD34 + cells per liter of blood processed (3.1 × 10 9 and 44 × 10 6 , respectively), whereas Caucasians had the lowest median yields at 2.8 × 10 9 and 33.7 × 10 6 , respectively. Multivariate analysis of CD34 + per liter mobilization yields using Caucasians as the comparator and controlling for age, gender, body mass index, and year of apheresis revealed increased yields in overweight and obese AA and API donors. In Hispanic donors, only male obese donors had higher CD34 + per liter mobilization yields compared with Caucasian donors. No differences in CD34 + per liter yields were seen between Caucasian and NA donors. Characterization of these differences may allow optimization of mobilization regimens to allow enhancement of mobilization yields without compromising donor safety. [ABSTRACT FROM AUTHOR]
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- 2015
- Full Text
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23. Pain, Donation-Related Symptoms and the Trajectory of Recovery in Children after Bone Marrow (BM) Donation Are Influenced By Age (Pre vs. Post-Puberty) and Sex: Primary Analysis of the Pediatric Toxicity Cohort of the Related Donor Safety Study (RDSafe).
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Pulsipher, Michael A., Logan, Brent R., Kiefer, Deidre M., Chitphakdithai, Pintip, Switzer, Galen E., Riches, Marcie L., Rizzo, J. Douglas, Anderlini, Paolo, Leitman, Susan F., Varni, James W., Kobusingye, Hati, Besser, RaeAnne M., Shaw, Bronwen E., O'Donnell, Paul V., Miller, John P., Drexler, Rebecca J., King, Roberta J., Horowitz, Mary M., and Confer, Dennis L.
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INSOMNIA , *BONE marrow transplantation , *SYMPTOMS , *JUVENILE diseases , *COHORT analysis , *MULTIVARIATE analysis - Published
- 2016
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24. A Change in Donor Medical Suitability Criteria Resulted in Decreased Rates of Donor Attrition at CT Stage in a Registry Study.
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Jr.Gallego, Aurelia, Billen, Annelies, Madrigal, J. Alejandro, and Shaw, Bronwen E.
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TRANSPLANTATION of organs, tissues, etc. , *ORGAN donor registries , *HEMATOPOIETIC stem cell transplantation , *BONE marrow transplantation , *TRANSPLANTATION immunology , *MEDICAL research - Published
- 2015
- Full Text
- View/download PDF
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