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1.
Incidence of cardiovascular disease in healthy Swedish peripheral blood stem cell donors - a nationwide study
Pahnke, S., Hägglund, H., Larfors, G.
Bone marrow transplantation. 2024
Abstract
Granulocyte colony-stimulating factor (G-CSF) is used in a majority of healthy donors to obtain peripheral blood stem cells for allogeneic stem cell transplantation. Since high levels of G-CSF activates endothelial cells and can induce a pro-coagulatory state, and fuelled by case reports of cardiovascular events in donors, some concerns have been raised about a potential for an increased risk of cardiovascular events for the donors after donation. We studied the incidence of cardiovascular disease following stem cell donation in a Swedish national register based cohort of 1098 peripheral blood stem cell donors between 1998 and 2016. The primary objective was to evaluate if the incidence of cardiovascular disease was increased for donors treated with G-CSF. The incidence of any new cardiovascular disease was 6.0 cases per 1000 person years, with a median follow up of 9.8 years. The incidence did not exceed that of age- sex- and residency-matched population controls (hazard ratio 0.90, 95% confidence interval (CI) 0.76-1.07, p-value 0.23), bone marrow donors, or non-donating siblings. Long-term cardiovascular disease incidence was not increased in this national register based study of peripheral blood stem cell donors treated with G-CSF.
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2.
Factors associated with opting out of an unrelated hematopoietic stem cell donor registry: Differences and similarities across five key groups of young race/ethnically diverse potential donor groups in the US
Hamed, A. B., Bruce, J. G., Kuniyil, V., Ahmed, N., Mattila, D., Williams, E. P., Dew, M. A., Myaskovsky, L., Confer, D. L., Switzer, G. E.
Transplantation and cellular therapy. 2024
Abstract
BACKGROUND Young adults from underserved racial/ ethnic groups are critically needed as unrelated hematopoietic stem cell (HSC) donors, yet they are more likely than other groups to opt out of donation after having matched a patient. Understanding which factors are most strongly associated with opting out among young underserved racial/ ethnic registered donors compared with their White counterparts will provide the basis for specific interventions to improve donor retention. OBJECTIVE We sought to determine the key, modifiable psychosocial, registry-related, and donation-related characteristics that are uniquely associated with opting out across five key racial/ethnic groups of young HSC donor registry members who had been contacted as a potential match for a patient. STUDY DESIGN This study examines data from a large cross-sectional survey of young (age 18-30) registry members shortly after they preliminarily matched a patient (CT-stage) and continued toward or opted out of donation (CT-C and CT-NI), stratified by racial/ethnic group and sex. We assessed psychosocial, registry-related, and donation-related characteristics for all participants. We used chi-squared and F tests to assess differences between racial/ethnic groups. A separate logistic regression analysis for each racial/ethnic group was conducted to quantify adjusted associations between each variable and opting out. Then, we compared these associations across the racial/ethnic groups by evaluating the interaction effect between each variable and racial/ethnic group, with the same outcome (CT-C vs. CT-NI) in question. RESULTS 935 participants were surveyed, including 284 White, 165 Hispanic, 191 Black, 192 Asian/Pacific Islander, and 103 Multiracial/multiethnic participants. There were significant differences across racial/ethnic groups in values/goals, religious objections to donation, HSC-related medical mistrust, and parental involvement in donation decisions. Adjusted logistic regression subgroup analyses indicated that ambivalence was strongly associated with opting out across all racial/ethnic groups. Greater focus on intrinsic life goals (e.g., raising a family, becoming a community leader, influencing social values) was associated with opting out in the Multiracial/multiethnic, Hispanic, and Asian/Pacific Islander groups. Healthcare mistrust and insufficient registry contact was a significant factor for Hispanic participants. Protective factors against opting out included remembering joining the registry (Black participants), and parental support for donation decision (Asian/Pacific Islander participants). The performance of each logistic regression model was strong, with area-under-the curve ≥ 0.88, CT-stage outcome classification accuracy ≥ 89%, and good fit between expected and observed opt-out probabilities. In the analysis across different racial/ethnic groups, the only significant interaction was race/ethnicity by whether more contact with the registry would have changed the decision at CT-stage; this variable was significant only for the Hispanic group. In the within-group analysis for Hispanic participants, the "more registry contact" variable was strongly associated with opting out (odds ratio 5.8, p=0.03). CONCLUSION Consistent with a growing body of HSC donor research, ambivalence was a key factor associated with opting-out for all racial/ethnic groups. Other key variables were differentially associated with opting-out depending on racial/ethnic group. Our study highlights key variables that registries should focus on as they develop targeted and tailored strategies to enhance commitment and reduce attrition of potential donors.
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3.
The effect of granulocyte colony stimulating factor on genotoxicity in allogeneic peripheral blood stem cell transplantation donors: a prospective case-control study
Çakmaklı, H. F., Gökçe, H., Söylemez, E., Topçuoğlu, P., Kayaaltı, Z., İleri, D. T.
The Turkish journal of pediatrics. 2023;65(5):809-821
Abstract
BACKGROUND Every year, thousands of donors are exposed to granulocyte-colony stimulating factor (G-CSF) for stem cell mobilization in hematopoietic stem cell transplantations (HSCT). Previous studies about the genotoxicity of G-CSF were inconclusive. In this study, the genotoxic effects of G-CSF in peripheral blood stem cell (PBSC) donors were evaluated prospectively by using three different validated and reliable methods for the first time in the literature to the best of our knowledge. METHODS Donors of PBSC transplantation (n=36), who received G-CSF were evaluated for genotoxicity by micronucleus test (MNT), nuclear division index (NDI), and comet assay (CA). Genotoxic effects are expected to cause an increase in MNT and CA values and decrease in NDI. Blood samples were collected at three timepoints (TP): before starting G-CSF (TP1), after G-CSF for five days (TP2), and one month after the last dose (TP3). Sixteen controls were included for baseline comparison of genotoxicity tests. CD34 cell counts and hemograms were also analyzed. RESULTS MNT and CA parameters; comet and tail length, tail DNA%, and tail moment, showed no change in time whereas another CA parameter, Olive`s tail moment (OTM) was increased significantly at TP3 compared to both baseline and TP2 (p=0.002 and p=0.017, respectively). Nuclear division index decreased significantly at TP2 (p < 0.001), then increased above baseline at TP3 (p=0.004). Baseline comparison with controls showed higher MN frequency in donors without statistical significance (p=0.059). Whereas, CA results were significantly higher in controls. CD34 cell count showed moderate positive correlation with white blood cell count at TP2 (Pearson R=0.495, p=0.004). CONCLUSIONS Our results showed the genotoxic effect of G-CSF in healthy donors, in two of the three tests performed, short-term effect in NDI, and long-lasting effect in OTM. So, this study provides novel information for the debate about the genotoxicity of G-CSF and supports the need for further studies with a larger sample size and longer follow-up.
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4.
Worries and Psychological Well-Being in Potential Hematopoietic Stem Cell Donors Before Donation-A Swedish National Study
Winterling, J., Pahnke, S., Lagnebjörk, J., Hägglund, H., Larfors, G., Lenhoff, S., Kisch, A. M.
Transplantation proceedings. 2023;55(1):242-248
Abstract
BACKGROUND The physical risks involved in donating hematopoietic stem cells have been thoroughly studied, but little is known about the psychological risks potential donors might face before donation. The aim of this study was to describe potential the pre-donation worries and psychological well-being of hematopoietic stem cell donors and investigate possible associations between donor characteristics and psychological well-being. METHODS In a cross-sectional, national cohort study, we describe pre-donation worries and psychological well-being and investigate possible associations between donor characteristics and psychological well-being. A questionnaire was sent to prospective adult hematopoietic stem cells donors. RESULTS The study included 210 participants, 47% of whom were related and 53% unrelated to the recipient. Of the participants, 39% reported great worry about the recipient and 12% great worry about themselves as potential donors. Symptoms of anxiety were expressed by 21%, whereas symptoms of depression were uncommon and perceived general mental health was slightly lower than in the Swedish population. Great worry about oneself, lower age, and female sex were related to increased anxiety and lower mental health. CONCLUSION This study highlighted that some potential donors report high levels of pre-donation worry and that greater worry about oneself, lower age, and female sex are associated with lower psychological well-being. Although further studies are needed to investigate this psychological risk over time, it is clear that some potential donors are particularly vulnerable.
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5.
[The potential of donorship: motives and factors of population joining the bone marrow registry]
Ishkineeva, F. F., Gerova, O. A., Ozerova, K. A., Andryushkina, A. V., Gayfullina, R. F.
Problemy sotsial'noi gigieny, zdravookhraneniia i istorii meditsiny. 2023;31(6):1344-1348
Abstract
The allogenic bone marrow transplantation has turned from experimental treatment method into standard therapy of many malignant hematological diseases, autoimmune disorders and immunodeficiency conditions. The need for bone marrow transplantation is experienced by thousands of patients with blood cancer at the limited number of real donors. The determining potential of donation, as well as identifying motives and factors that contribute into or prevent joining of citizens the register of bone marrow donors, is of particular actuality. The study was carried out in two stages, based on combined strategy of methods for collecting empirical information (mixed methods research). At the first stage, based on the results of series of in-depth interviews implemented within the framework of the Blood 5 media project (Rusfond, 2019), the types of motivations for donation were identified. At the second stage (June 2022) formalized survey of potential donors of the Vasya Perevoshchikov National Register of Bone Marrow Donors (hereinafter referred to as the National Register) was carried out. The sampling included 8037 respondents: 13.7% of all bone marrow donors listed in the National Register. The opinions of the Russians that joined the National Register demonstrate complicated picture of motives and factors determining personal strategies and experience of participation in donation. The fears and obstacles to bone marrow donation are widespread in public consciousness due to insufficient information about donorship procedure and its consequences. The donorship potential is rather high, but it is not fully implemented. The Russians are frustrated about participating in donorship. They understand the need for donorship, realize it as moral duty, as complicity to important cause, empathy towards patients. At the same time they are afraid for their health, because they are not sufficiently aware of the essence of donorship and its consequences.
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6.
Ethylene oxide-type hypersensitivity reactions in G-CSF mobilized, peripheral blood hematopoietic progenitor cell donors and review
Cooling, L., Sherbeck, J.
Journal of clinical apheresis. 2023
Abstract
BACKGROUND Ethylene oxide (EtO) is a volatile, ringed toxic ether used to sterilize heat-labile plastics including apheresis sets. In the 1980s, EtO-associated severe hypersensitivity reactions during hemodialysis led to widespread adoption of alternative sterilization for dialysis kits but not apheresis tubing sets. We now report several cases of EtO-type hypersensitivity reactions in autologous donors undergoing hematopoietic progenitor cell collection (HPCC). MATERIALS AND METHODS A 10-year retrospective review of allergic EtO-type reactions in adults undergoing HPCC on the COBE Spectra and SPECTRA Optia was performed. Donor medical history and absolute eosinophil counts were compared between cases and 34 HPCC controls. Published EtO reactions during extracorporeal procedures were reviewed with statistical analysis. Graphics and statistics were performed using commercial software. RESULTS Three autologous HPCC donors experienced EtO-type reactions within 15 min of initiating HPCC, for a 10-year incident rate of 0.08% per procedure and 0.18% per donor. All three reactions occurred using the Spectra Optia and IDL tubing set, for an Optia/IDL specific rate of 0.2% per procedure and 0.5% per donor. There was no correlation between EtO reactions, eosinophil counts, or saline prime dwell times. No patient had classic predisposing risk factors for EtO hypersensitivity. Two patients required medical intervention whereas the third responded by pausing the procedure and slowing the inlet rate. CONCLUSION EtO-type hypersensitivity reactions can be observed during HPCC, especially with the Optia IDL tubing set. EtO reactions may be missed due to their rarity and staff unfamiliarity with this clinical entity.
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7.
Favorable recovery profiles and good reliability among youngest unrelated stem cell donors supports lowering the minimum donor registration age
Ros-Soto, J., Pryce, A., Zoubek, E., Burlton, C., Szydlo, R., Anthias, C.
Journal of clinical apheresis. 2023
Abstract
INTRODUCTION Younger donor age in hematopoietic cell transplantation has been associated with improved overall and disease-free survival. Safety data on peripheral blood stem cell (PBSC) and bone marrow (BM) donation is well established, including in the <18-year old age group in the related setting. In response, Anthony Nolan became the first stem cell donor registry to lower the minimum age for unrelated donors to 16-years. MATERIALS AND METHODS This retrospective study reviewed unrelated donors donating PBSC or BM for the first time between April 2015 and October 2017 since adoption of the lowered recruitment age. Data were collected from registry electronic database and structured follow-up questionnaires. Primary outcomes were turnaround time from VT to donation, optimal cell yield achievement, and physical and emotional recovery. RESULTS Out of a total of 1013 donors, there were no differences between the different age groups in proportion of donors achieving optimal CD34(+) or TNC (PBSC and BM, respectively). There was no increased central line requirement for younger donors or increased emergency telephone support. Youngest donors were more likely to report physical recovery 2 and 7 days post-PBSC (P = .024 and P = .015, respectively) as well as an earlier emotional recovery (P = .001) and fewer physical symptoms 1 week BM donation (P = .04). CONCLUSION This study shows that younger donors are as reliable as older donors, and have favorable recovery profiles without need for increased support at any stage of the donation, supporting Anthony Nolan recruitment strategy and offering reassurance to donor registries considering the same.
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8.
Assessing the cognition, attitudes and intentions of volunteers regarding unrelated peripheral blood stem cell donation: The UPBSC-DQ instrument in Chinese
Ding, N., Ye, Z., Jin, X., Zhang, G., Yu, Q., Liu, Y.
Heliyon. 2023;9(11):e20663
Abstract
OBJECTIVES This study aimed to develop and validate the Unrelated Peripheral Blood Stem Cell Donation Questionnaire (UPBSC-DQ) (an instrument in Chinese) to assess the degree of cognition, attitude and intention of enrolled volunteers towards UPBSC donation. METHODS The development process of the UPBSC-DQ was performed in a stepwise approach that included extensive literature retrieval, expert revision, and pretesting with 442 students. We conducted an online cross-sectional survey using the final version of the UPBSC-DQ among 336 participants. The reliability of the questionnaire was assessed by Cronbach's α and corrected item-total correlation (CITC), and the validity was evaluated by a correlation coefficient matrix, confirmatory factor analysis (CFA), and t-test. RESULTS The UPBSC-DQ consists of four domains: basic information, cognitive, attitude, and intention. The Cronbach's α values were 0.88 and 0.86 for the attitude and intention scales, respectively, indicating strong internal consistency and good reliability. Correlation analysis and CFA showed good structure and content validity. Interitem correlations indicated that each item had only a weak correlation with the other scales. CONCLUSIONS The UPBSC-DQ is a reliable and valid assessment questionnaire for individuals' attitudes and intentions towards UPBSC donation. The questionnaire showed good to high reliability, content and construct validity.
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9.
Pediatric Hematopoietic Cell Transplantation: A Longitudinal Assessment of Health-Related Quality of Life of Pediatric Donors
Hou, S. H. J., Stokoe, M., Zwicker, H., Young-Speirs, M., Pelletier, W., Guilcher, G. M. T., Khu, M., Schulte, F. S. M.
Journal of clinical psychology in medical settings. 2023
Abstract
Pediatric donors may be at increased risk of psychological and social challenges following hematopoietic cell transplantation (HCT). Through a retrospective chart review, we evaluated the health-related quality of life (HRQL) of pediatric donors over time and examined facilitators and barriers to implementing a longitudinal psychosocial assessment. Fifty-one pediatric donors (M = 10.7 years, SD = 3.7) completed an HRQL questionnaire across six time points (T1 to T6) from prior to donation to 2 years after. Change in mean scores was assessed using a linear mixed-effect model for repeated measures design. Facilitators and barriers to implementation were examined. HRQL of pediatric donors improved between T1 and T6 with significant change in physical, emotional, and overall functioning. Facilitators to retention included the support of a clinical coordinator. Barriers to implementation included the absence of infrastructure to maintain contact with pediatric and their families. HRQL of pediatric donors of HCT improved steadily over time. Pattern of results suggests a need to further explore factors that contribute to change across time. Development of a longitudinal standardized assessment protocol that can be prospectively and feasibly implemented is integral to supporting the well-being of this group.
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10.
Superior physical and mental health of healthy volunteers before and five years after mobilized stem cell donation
Heyn, J., Bräuninger, S., Dimova-Dobreva, M., Mathieson, N., Koptelova, N., Kolpakova, A., Seidl, C., Reinhardt, P., Tsamadou, C., Schrezenmeier, H., et al
Journal of translational medicine. 2022;20(1):121
Abstract
BACKGROUND Safety, tolerability and efficacy of granulocyte colony-stimulating factor (G-CSF) for mobilization of hematopoietic stem and progenitor cells (HSPCs) from healthy donors have been conclusively demonstrated. This explicitly includes, albeit for smaller cohorts and shorter observation periods, biosimilar G-CSFs. HSPC donation is non-remunerated, its sole reward being "warm glow", hence harm to donors must be avoided with maximal certitude. To ascertain, therefore, long-term physical and mental health effects of HSPC donation, a cohort of G-CSF mobilized donors was followed longitudinally. METHODS We enrolled 245 healthy volunteers in this bi-centric long-term surveillance study. 244 healthy volunteers began mobilization with twice-daily Sandoz biosimilar filgrastim and 242 underwent apheresis after G-CSF mobilization. Physical and mental health were followed up over a period of 5-years using the validated SF-12 health questionnaire. RESULTS Baseline physical and mental health of HSPC donors was markedly better than in a healthy reference population matched for ethnicity, sex and age. Physical, but not mental health was sharply diminished at the time of apheresis, likely due to side effects of biosimilar G-CSF, however had returned to pre-apheresis values by the next follow-up appointment after 6 months. Physical and mental health slightly deteriorated over time with kinetics reflecting the known effects of aging. Hence, superior physical and mental health compared to the general healthy non-donor population was maintained over time. CONCLUSIONS HSPC donors are of better overall physical and mental health than the average healthy non-donor. Superior well-being is maintained over time, supporting the favorable risk-benefit assessment of volunteer HSPC donation. Trial registration National Clinical Trial NCT01766934.