RESUMO
INTRODUCTION: This prospective multicentre study evaluates the impact of Palliative Care Unit (PCU) intervention (Experimental Group, EG), during autologous hematopoietic stem cell transplantation (AHSCT) on quality of life (QoL), symptom control and healthcare resource use compared to standard practice (Control Group, CG). We used validated scales on Days 0 (stem cell infusion), + 7 (bone marrow aplasia, acute symptoms) and + 21 (aplasia recovery). RESULTS: In 40 patients (20 EG/ 20 CG: 45%/25% female, median age 57.5/59), QoL differed significantly at Day + 7 (EG: median 0.50; CG: -63.00; p < 0.001) and Day + 21 (EG: -2.00; CG: -129.00; p < 0.001). On Day 0, mean FACT-BMT scores were CG/EG: 131/ 89.35, reflecting the pre-transplant intervention of the PCU in EG patients. For pain (EG median 0.00, CG median 2.50; p = 0.01), 45% EG patients used opioids on day 0 (mean 38.5 mg morphine/day/patient). Reduced pain control impacted nutritional support (parenteral nutrition 45% CG, 5% EG; p = 0.08). Hospitalisation duration was longer in CG (median 18.5; EG median 13.00; p < 0.001). Despite the short follow-up and small sample size, PCU and HD collaboration improves QoL and symptom management during acute AHSCT, evident through pain control, analgesia management, reduced parenteral nutrition need and shorter hospital stays.
Assuntos
Transplante de Medula Óssea , Estudos de Viabilidade , Cuidados Paliativos , Qualidade de Vida , Transplante Autólogo , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Cuidados Paliativos/métodos , Cuidados Paliativos/normas , Estudos Prospectivos , Transplante de Medula Óssea/métodos , Transplante de Medula Óssea/normas , Qualidade de Vida/psicologia , Transplante Autólogo/métodos , Adulto , Idoso , Manejo da Dor/métodos , Manejo da Dor/normasRESUMO
Data on recent bone marrow harvest (BMH) collections from the NMDP has shown that bone marrow (BM) quality has decreased based on total nucleated cell count in the product. To ensure that quality BM products are available to all recipients, the NMDP Marrow Alliance was formed in April 2021 to increase the capability of BM collection centers to safely deliver high-quality products consistently and to identify and disseminate guidelines for performing BMH. This white paper describes the best practices for BMH as defined by the NMDP Marrow Alliance.
Assuntos
Medula Óssea , Humanos , Transplante de Medula Óssea/normas , Transplante de Medula Óssea/métodos , Guias de Prática Clínica como Assunto , Células da Medula Óssea , Coleta de Tecidos e Órgãos/métodos , Coleta de Tecidos e Órgãos/normasRESUMO
Aborda sobre o atendimento por modalidade de transplantes via SUS, em Goiás. Apresenta as unidades de saúde e profissionais responsáveis. Discorre sobre o fluxo de regulação de transplantes no estado, o fluxo de exames para a inscrição, manutenção e acompanhamento do potencial receptor, os direito dos usuários dos serviços de transplantes e o tratamento fora do domicílio. Orienta sobre o Fluxo Geral de Regulação para Consulta de Avaliação em Transplantes
It addresses the care by type of transplant via SUS in the state of Goiás. It presents the health units and responsible professionals. It discusses the flow of regulation of transplants in the state, the flow of exams for the registration, maintenance and monitoring of the potential recipient, the rights of users of transplant services and treatment outside the home. Guidance on the General Regulation Flow for Evaluation Consultation in Transplants
Aborda la atención por tipo de trasplante vía SUS en el estado de Goiás. Presenta las unidades de salud y los profesionales responsables. Discute el flujo de regulación de trasplantes en el estado, el flujo de exámenes para el registro, mantenimiento y seguimiento del potencial receptor, los derechos de los usuarios de los servicios de trasplante y el tratamiento fuera del hogar. Guías sobre el Reglamento General de Flujo para la Consulta de Evaluación en Trasplantes
Assuntos
Humanos , Transplantes/normas , Acessibilidade aos Serviços de Saúde/organização & administração , Transplante de Tecidos/normas , Transplante de Medula Óssea/normas , Transplante de Córnea/normas , Transplante de Rim/normas , Transplante de Fígado/normas , Músculo Esquelético/transplanteRESUMO
The SARS-CoV-2 (COVID-19) pandemic has rapidly impacted cell therapy activities across the globe. Not only was this, unexpected event, a threat to patients who had previously received hematopoietic cell transplantation or other cell therapy such as CAR-T cells, but also, it was responsible for a disruption of cell therapy activities due to the danger of the virus and to the lack of solid scientific data on the management of patients and donors. The Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC) devoted a workshop to issue useful recommendations in such an unexpected event in order to harmonize the actions of all the actors involved in cellular therapy programs so that we can collectively face, in the future, the challenges that could threaten our patients. This work is not specifically dedicated to the SARS-CoV-2 outbreak, but the latter has been used as a concrete example of an unexpected event to build up our recommendations.
Assuntos
Transplante de Medula Óssea/normas , COVID-19/epidemiologia , Transplante de Células/normas , Pandemias , Criopreservação , Acessibilidade aos Serviços de Saúde , Transplante de Células-Tronco Hematopoéticas/normas , Humanos , Imunoterapia Adotiva/normas , Receptores de Antígenos Quiméricos/uso terapêutico , Sociedades Médicas , Doadores de TecidosAssuntos
Enfermagem Baseada em Evidências/organização & administração , Cooperação Internacional , Sociedades de Enfermagem/organização & administração , Ásia , Transplante de Medula Óssea/enfermagem , Transplante de Medula Óssea/normas , Educação Continuada em Enfermagem/organização & administração , Europa (Continente) , Saúde Global , Transplante de Células-Tronco Hematopoéticas/enfermagem , Transplante de Células-Tronco Hematopoéticas/normas , Humanos , América Latina , Papel do Profissional de Enfermagem , Controle de QualidadeRESUMO
Spermatogenic dysfunction caused by cyclophosphamide (CP) chemotherapy has seriously influenced the life quality of patients. Unfortunately, treatments for CP-induced testicular spermatogenic dysfunction are limited, and the molecular mechanisms are not fully understood. For the first time, here, we explored the effects of bone marrow mesenchymal stem cell-derived exosomes (BMSC-exos) on CP-induced testicular spermatogenic dysfunction in vitro and in vivo. BMSC-exos could be taken up by spermatogonia (GC1-spg cells). CP-injured GC1-spg cells and BMSC-exos were cocultured at various doses, and then, cell proliferation was measured using 3-[4,5-dimethylthiazol-2-yl]-2,5 diphenyl tetrazolium bromide (MTT) assay. In addition, photophosphorylation of extracellular-regulated kinase (ERK), p38 mitogen-activated protein kinase (p38MAPK), and protein kinase B (AKT) proteins was evaluated by western blotting as well as apoptosis in GC1-spg cells measured using flow cytometry. Treatment with BMSC-exos enhanced cell proliferation and reduced apoptosis of CP-injured GCI-spg cells. Phosphorylated levels of ERK, AKT, and p38MAPK proteins were reduced in CP-injured spermatogonia when co-treated with BMSC-exos, indicating that BMSC-exos acted against the reproductive toxicity of CP via the p38MAPK/ERK and AKT signaling pathways. In experiments in vivo, CP-treated rats received BMSC-exos by injection into the tail vein, and testis morphology was compared between treated and control groups. Histology showed that transfusion of BMSC-exos inhibited the pathological changes in CP-injured testes. Thus, BMSC-exos could counteract the reproductive toxicity of CP via the p38MAPK/ERK and AKT signaling pathways. The findings provide a potential treatment for CP-induced male spermatogenic dysfunction using BMSC-exos.
Assuntos
Transplante de Medula Óssea/normas , Ciclofosfamida/efeitos adversos , Fatores de Proteção , Transplante de Medula Óssea/métodos , Transplante de Medula Óssea/estatística & dados numéricos , Exossomos/metabolismo , Humanos , Proteínas Proto-Oncogênicas c-akt/genética , Proteínas Proto-Oncogênicas c-akt/metabolismo , Transdução de Sinais/efeitos dos fármacos , Proteínas Quinases p38 Ativadas por Mitógeno/metabolismoRESUMO
Heterogeneous practices exist across transplant centres regarding assessment prior to allogeneic haematopoietic cell transplantation (allo-HCT) for myelofibrosis, post-transplant monitoring and management of relapse. The 'Practice Harmonisation and Guidelines' and Myeloproliferative Neoplasms subcommittees of the Chronic Malignancies Working Party (CMWP) of the EBMT generated an electronic survey proposal to investigate approaches to the above aspects of myelofibrosis allo-HCT practice. This survey was sent to a total of 65 centres experienced in allo-HCT for myelofibrosis across Europe in February 2020. By time of survey closure, a total of 36 centres (55 %) had completed the survey. Responses were aggregated and reported in a comparative fashion. Marked variations in assessment prior to allo-HCT, JAK inhibitor management peri-transplant, molecular, histopathological and cytogenetic monitoring and approaches to the definition and management of relapse were apparent across surveyed centres. On the basis of these findings, future CMWP efforts will focus on defining guidelines for relapse definition in MF allo-HCT and also suggested optimal monitoring practices for the transplant community.
Assuntos
Transplante de Células-Tronco Hematopoéticas , Padrões de Prática Médica/estatística & dados numéricos , Mielofibrose Primária/terapia , Transfusão de Sangue/normas , Transplante de Medula Óssea/normas , Doença Crônica , Europa (Continente)/epidemiologia , Doença Enxerto-Hospedeiro/epidemiologia , Fidelidade a Diretrizes/normas , Fidelidade a Diretrizes/estatística & dados numéricos , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco Hematopoéticas/métodos , Transplante de Células-Tronco Hematopoéticas/normas , Transplante de Células-Tronco Hematopoéticas/estatística & dados numéricos , Humanos , Neoplasias/terapia , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/normas , Mielofibrose Primária/epidemiologia , Mielofibrose Primária/patologia , Recidiva , Estudos Retrospectivos , Sociedades Médicas/organização & administração , Sociedades Médicas/normas , Inquéritos e Questionários , Medicina Transfusional/organização & administração , Medicina Transfusional/normas , Medicina Transfusional/estatística & dados numéricos , Transplante Homólogo/efeitos adversos , Transplante Homólogo/estatística & dados numéricosRESUMO
Beta thalassaemia major is an inherited condition that causes severe anaemia. Patients with the condition require regular blood transfusions. One curative treatment option available is bone marrow transplantation, but a bone marrow transplant is a high-risk, painful procedure requiring prolonged hospitalisation. Undergoing such a disruptive treatment can be a source of great anxiety for young people and their families, who will need honest, sensitive and empathetic communication, person-centred care, support to socialise and access education, involvement in decision-making and signposting to financial support. This article discusses the role of children's nurses in addressing the psychosocial needs of young people with thalassaemia who undergo bone marrow transplantation and in supporting young people's families.
Assuntos
Transplante de Medula Óssea/normas , Qualidade de Vida/psicologia , Talassemia/complicações , Adolescente , Transplante de Medula Óssea/métodos , Transplante de Medula Óssea/psicologia , Criança , Humanos , Talassemia/psicologiaRESUMO
Despite the increasing role of molecular markers, differential counts and morphology of hematopoietic cells in the bone marrow (BM) remain essential diagnostic criteria in hematological diseases. However, the respective reference values for BM myelogram commonly used came from small series with limited numbers of healthy individuals. We evaluated the myelograms of 236 healthy individuals who underwent unrelated bone marrow donation. Health check-ups were performed 4 weeks prior to harvest. Samples for this study, taken from the first aspiration, were stained according to the standard Pappenheim method. Three experienced investigators assessed cellularity, megakaryopoiesis, and differential counts independently. The median donor age was 31 (range 18-51) years. Predonation tests did not reveal any relevant morbidity. Thirty-seven out of 42 hypocellular marrow samples were from younger donors up to 39 years. Content of megakaryocytes was normal in 210 specimens (89%). Gender and body mass index had significant impact on hematopoiesis, whereas age had not. The number of erythroblasts was higher (about 32%) and the proportion granulopoiesis slightly lower (about 50%) compared with previous studies. Differential counts showed also some differences with respect to individual maturation stages in these lines. Interrater comparisons showed greater reliability for the assignment of cells to the different hematopoietic cell lines than for single-cell diagnoses. This study largely confirms the results for cell counts in normal human bone marrow available from previous reports and provides some insights into factors that affect individual cell populations. It also reveals substantial variability among even experienced investigators in cytological diagnoses.
Assuntos
Contagem de Células Sanguíneas/normas , Células da Medula Óssea/fisiologia , Transplante de Medula Óssea/normas , Doadores Vivos , Adolescente , Adulto , Contagem de Células Sanguíneas/métodos , Transplante de Medula Óssea/métodos , Contagem de Células/métodos , Contagem de Células/normas , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Distribuição Aleatória , Valores de Referência , Reprodutibilidade dos Testes , Estudos Retrospectivos , Adulto JovemRESUMO
OBJECTIVE: To describe the experience of nursing, in adopting containment measures, in the care of patients undergoing hematopoietic stem cell transplantation to avoid COVID-19. METHODS: Experience report. RESULTS: Containment measures involve those recommended by major health organizations, such as hand hygiene, social isolation, identification and monitoring of suspected or confirmed cases; and also the local measures implemented in the health service, such as the reduction in the number of hospitalizations for transplantation, clinical screening of outpatients entering the service, monitoring of respiratory signs and symptoms, the allocation of specific isolation rooms for those suspected of the disease and testing of symptomatic patients. Final considerations: The nurse is responsible for the challenge of planning nursing care to prevent the spread of coronavirus in a high-risk population and to implement measures based on available evidence, periodically updated.
Assuntos
Transplante de Medula Óssea/enfermagem , Transplante de Medula Óssea/normas , Infecções por Coronavirus/prevenção & controle , Controle de Infecções/normas , Programas de Rastreamento/normas , Cuidados de Enfermagem/normas , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Guias de Prática Clínica como Assunto , Betacoronavirus , COVID-19 , Humanos , SARS-CoV-2RESUMO
BACKGROUND: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration's (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine. OBJECTIVES: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around "minimal manipulation" and "homologous use" within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine. METHODS: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. RESULTS/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions. ⢠The evidence is highest for knee osteoarthritis with level II evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies. There is level III evidence for knee cartilage conditions. ⢠Based on the relevant systematic reviews, randomized trials, and nonrandomized studies, the evidence for disc injections is level III. ⢠Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections. Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique. Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements with a wide array of treatment modalities. Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use. Statement 6: Development of cell-based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes having putative potential, and has led the FDA Federal Trade Commission (FTC) to issue multiple warnings. Thus the US FDA is considering the appropriateness of using various therapies, including BMC, for homologous use. Statement 7: Since the 1980's and the description of mesenchymal stem cells by Caplan et al, (now called medicinal signaling cells), the use of BMC in musculoskeletal and spinal disorders has been increasing in the management of pain and promoting tissue healing. Statement 8: The Public Health Service Act (PHSA) of the FDA requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is provided by preclinical and clinical evidence. Statement 9: If the FDA does not accept BMC as homologous, then it will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use. Statement 10: This literature review and these position statements establish compliance with the FDA's intent and corroborates its present description of BMC as homologous with same surgical exemption, and exempt from IND, for use of BMC for treatment of musculoskeletal tissues, such as cartilage, bones, ligaments, muscles, tendons, and spinal discs. CONCLUSIONS: Based on the review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use. KEY WORDS: Cell-based therapies, bone marrow concentrate, mesenchymal stem cells, medicinal signaling cells, Food and Drug Administration, human cells, tissues, and cellular tissue-based products, Public Health Service Act (PHSA), minimal manipulation, homologous use, same surgical procedure exemption.
Assuntos
Transplante de Medula Óssea/normas , Medicina Baseada em Evidências/normas , Doenças Musculoesqueléticas/terapia , Manejo da Dor/normas , Médicos/normas , Sociedades Médicas/normas , Medula Óssea/fisiologia , Transplante de Medula Óssea/métodos , Medicina Baseada em Evidências/métodos , Humanos , Doenças Musculoesqueléticas/diagnóstico , Doenças Musculoesqueléticas/epidemiologia , Dor/diagnóstico , Dor/epidemiologia , Manejo da Dor/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration/normasRESUMO
OBJECTIVE: The functional assessment of cancer therapy-bone marrow transplant (FACT-BMT) is a widely used instrument to assess quality of life (QOL) in hematopoietic stem cell transplant (HSCT) patients, but there is little evidence of its validity in Latin American populations. This study evaluated the psychometric properties of the Spanish language version of the FACT-BMT in Mexican patients. METHOD: First, the original version was piloted with 15 HSCT patients to obtain an adequate cultural version, resulting in the adaptation of one item. After that, the new version was completed by 139 HSCT patients. RESULTS: The results showed a FACT factor structure that explains 70.84% of the total variance, a factor structure similar to the original FACT structure, and with a high internal consistency (Cronbach's alpha = 0.867). For the BMT subscale, the best factor structure included 17 items which explain 61.65% of the total variance with an adequate internal consistency (Cronbach's alpha = 0.696). SIGNIFICANCE OF THE RESULTS: The FACT-BMT was found to be a valid and reliable instrument to evaluate QOL in Mexican patients. Our results constitute new FACT-BMT empirical evidence that supports its clinical and research uses.
Assuntos
Transplante de Medula Óssea/normas , Neoplasias Ósseas/terapia , Pacientes/psicologia , Psicometria/normas , Qualidade de Vida/psicologia , Adulto , Transplante de Medula Óssea/métodos , Transplante de Medula Óssea/estatística & dados numéricos , Neoplasias Ósseas/psicologia , Feminino , Humanos , Masculino , México , Pessoa de Meia-Idade , Pacientes/estatística & dados numéricos , Psicometria/instrumentação , Psicometria/métodos , Reprodutibilidade dos Testes , Inquéritos e Questionários , TraduçãoRESUMO
ABSTRACT Objective: To describe the experience of nursing, in adopting containment measures, in the care of patients undergoing hematopoietic stem cell transplantation to avoid COVID-19. Methods: Experience report. Results: Containment measures involve those recommended by major health organizations, such as hand hygiene, social isolation, identification and monitoring of suspected or confirmed cases; and also the local measures implemented in the health service, such as the reduction in the number of hospitalizations for transplantation, clinical screening of outpatients entering the service, monitoring of respiratory signs and symptoms, the allocation of specific isolation rooms for those suspected of the disease and testing of symptomatic patients. Final considerations: The nurse is responsible for the challenge of planning nursing care to prevent the spread of coronavirus in a high-risk population and to implement measures based on available evidence, periodically updated.
RESUMEN Objetivo: Describir la experiencia de la enfermería, en la adopción de medidas de contención, en la atención de pacientes sometidos al trasplante de células madre hematopoyéticas para evitar la COVID-19. Métodos: Relato de experiencia. Resultados: Las medidas de contención envuelven aquellas recomendadas por las principales organizaciones de salud, como la higiene de manos, aislamiento social, identificación y monitoreo de casos sospechosos o confirmados; y aún las medidas locales implementadas en el servicio de salud, como la reducción en el número de internamientos para el trasplante, selección clínica de pacientes ambulatorios que adentran el servicio, monitoreo de señales y síntomas respiratorios, destinación de cuartos de aislamiento específicos para los sospechosos de la enfermedad y análisis de pacientes sintomáticos. Consideraciones finales: Compete al enfermero el desafío de planear el cuidado de enfermería para la prevención de la diseminación del coronavirus en población de alto riesgo y para la implementación de medidas pautadas en las evidencias disponibles, periódicamente actualizadas.
RESUMO Objetivo: Descrever a experiência da enfermagem, na adoção de medidas de contenção, no atendimento de pacientes submetidos ao transplante de células-tronco hematopoiéticas para evitar a COVID-19. Métodos: Relato de experiência. Resultados: As medidas de contenção envolvem aquelas recomendadas pelas principais organizações de saúde, como a higiene de mãos, isolamento social, identificação e monitoramento de casos suspeitos ou confirmados; e ainda as medidas locais implementadas no serviço de saúde, como a redução no número de internações para o transplante, triagem clínica de pacientes ambulatoriais que adentram o serviço, monitoramento de sinais e sintomas respiratórios, destinação de quartos de isolamento específicos para os suspeitos da doença e testagem de pacientes sintomáticos. Considerações finais: Compete ao enfermeiro o desafio de planejar o cuidado de enfermagem para a prevenção da disseminação do coronavírus em população de alto risco e para a implementação de medidas pautadas nas evidências disponíveis, periodicamente atualizadas.
Assuntos
Humanos , Pneumonia Viral/prevenção & controle , Programas de Rastreamento/normas , Transplante de Medula Óssea/enfermagem , Transplante de Medula Óssea/normas , Controle de Infecções/normas , Guias de Prática Clínica como Assunto , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Cuidados de Enfermagem/normas , BetacoronavirusRESUMO
OBJECTIVES: Haematopoietic stem cell transplantation (HSCT) in Oman started in 1994 at Sultan Qaboos University Hospital (SQUH), Muscat, Oman. Previous studies have suggested that longer driving time to the transplant centre (DTC) independently correlates with worse overall survival (OS). Therefore, this study aimed to examine the impact of DTC on OS and acute graft-versus-host disease (aGvHD). METHODS: This retrospective study included all patients who underwent HSCT between February 2006 and December 2016 at SQUH. The DTC was determined using Google Maps (Google LLC., Mountain View, California, USA). The probability of OS was estimated using a Kaplan-Meier estimator and the impact of DTC on OS was compared using a Cox model. RESULTS: A total of 170 patients were included in this study of which 52% were male and 28% were from the Al Batinah region. The mean age was 14.2 ± 12.2 years. The mean haemoglobin, platelet and white blood cell counts before the HSCT were 10.3 ± 1.7 g/dL, 207 ± 131 × 109/L and 5.1 ± 5.9 × 109/L, respectively. The median DTC for those with aGvHD was 84 minutes, which is similar to patients without aGvHD (P = 0.918). The hazard ratio for DTC as a predictor of OS was 1.0 (P = 0.901). CONCLUSION: In this single centre study, DTC did not impact aGvHD or OS in patients post-HSCT. The study was limited by its retrospective design and the small sample size. It is recommended that these results be confirmed in a prospective study.
Assuntos
Transplante de Medula Óssea/métodos , Cuidado Transicional/normas , Resultado do Tratamento , Adolescente , Adulto , Transplante de Medula Óssea/normas , Criança , Pré-Escolar , Feminino , Serviços de Assistência Domiciliar/normas , Humanos , Masculino , Omã , Modelos de Riscos Proporcionais , Estudos Prospectivos , Estudos Retrospectivos , Análise de SobrevidaRESUMO
Allogeneic hematopoietic cell transplantation (HCT) is part of the standard of care for many hematological diseases. Over the last decades, significant advances in patient and donor selection, conditioning regimens as well as supportive care of patients undergoing allogeneic HCT leading to improved overall survival have been made. In view of many new treatment options in cellular and molecular targeted therapies, the place of allogeneic transplantation in therapy concepts must be reviewed. Most aspects of HCT are well standardized by national guidelines or laws as well as by certification labels such as FACT-JACIE. However, the requirements for human resources, construction and layout of a unit treating patients during the transplantation procedure and for different complications are not well defined. Here, we describe the process of planning a transplant unit in order to open a discussion that could lead to more precise guidelines in the field of personnel and infrastructural requirements for hospitals caring for people with severe immunosuppression.
Assuntos
Transplante de Medula Óssea/normas , Ambiente de Instituições de Saúde/normas , Doenças Hematológicas/terapia , Transplante de Células-Tronco Hematopoéticas/normas , Ar/normas , Terapia Baseada em Transplante de Células e Tecidos/normas , Dieta Saudável/normas , Seleção do Doador/normas , França , Pessoal de Saúde/normas , Unidades Hospitalares/normas , Humanos , Higiene , Terapia de Imunossupressão/normas , Monitorização Fisiológica/métodos , Roupa de Proteção/normas , Sociedades Médicas , Esterilização/normas , Transplante Homólogo/normas , Visitas a PacientesRESUMO
JACIE (Joint Accreditation Committee ISTC EBMT) regulations and standards impose a quality and safety requirement for graft reinjection by nurses. However, the standards do not provide a step-by-step graft reinjection procedure. Because of high medical team turnover, the opening of new transplant centers, and continual questions from colleagues trying to decipher the JACIE standards, the need for a specific procedure goes without saying. We collected graft reinjection procedures from each SFGM-TC center that participated in our survey, thus creating an inventory of the different steps that make up graft reinjection. In addition to reviewing the main regulatory texts and JACIE standards, we sought advice from medical and cellular therapy experts. We observed that most centers use a mix of practices and some unjustified practices. In some transplant units, it is still standard practice to defrost cell therapy products in the transplant unit. Caregivers are aware of the need for a rigorous application of the regulatory requirements and are willing to administer a procedure that provides specific steps for each stage of the process. In this workshop, we questioned each stage of the graft reinjection procedure, which helped us define clear methods of implementation. In the form of a checklist, we offer bone marrow and stem cell transplant units a step-by-step procedure.
Assuntos
Transplante de Medula Óssea/normas , Transplante de Células-Tronco Hematopoéticas/normas , Retratamento/normas , Transplante de Medula Óssea/legislação & jurisprudência , Transplante de Medula Óssea/métodos , Criopreservação , França , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Transplante de Células-Tronco Hematopoéticas/métodos , Humanos , Sistemas de Identificação de Pacientes/métodos , Pré-Medicação/métodos , Pré-Medicação/normas , Retratamento/efeitos adversos , Retratamento/métodos , Sociedades Médicas , TemperaturaRESUMO
BACKGROUND: Bone marrow harvest (BMH) for haematopoietic stem cell transplantation is a well-established procedure. The guidelines of World Marrow Donor Association provide information on donor selection. However, some of the guidelines regarding donors with anaemia prior to harvest lack in supporting data from clinical studies. With this study, we aimed to provide such data. MATERIAL AND METHODS: In this retrospective, single-centre study, we analysed the interplay between haemoglobin levels and BMH and BMH impact on haemoglobin levels in a cohort of 149 unrelated BM donors, including 13 subjects with mild anaemia. RESULTS: The BMH led to significantly lower decrease in haemoglobin levels in donors with anaemia than in control group (1·79 g/dl vs. 2·56 g/dl, P < 0·0001). The following parameters: BMH volume (ml), BMH volume/donor body weight (ml/kg), total nucleated cells (TNC) in product (×108 ) and TNC/kg recipient body weight in product (×108 /kg) did not differ significantly between those two analysed groups (P > 0·05). Median BM volume harvested from anaemic donors was 16·34 ml/kg; none of them required blood transfusion after BMH. CONCLUSION: Mild anaemia prior to BMH does not significantly impact the collection results. The BMH is safe and feasible in donors with mild anaemia.
Assuntos
Anemia/sangue , Doadores de Sangue , Transplante de Medula Óssea/métodos , Seleção do Doador/métodos , Adulto , Células da Medula Óssea/química , Transplante de Medula Óssea/normas , Seleção do Doador/normas , Feminino , Hemoglobinas/análise , Humanos , Pessoa de Meia-IdadeRESUMO
The Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC) hold its eighth practice harmonization workshops on September 2017. In a workshop dedicated to chimeric antigen receptor T-cell therapy (CAR T-cells), the society issued recommendations regarding the prerequisite for hematopoietic cellular therapy programs to set up CAR T-cell therapy. In this article we focused on the prerequisite needed, in France, for a hematopoietic transplantation unit to start a CAR T-cell program with industrial manufactured cells within investigational products or after market access authorization.
Assuntos
Transplante de Medula Óssea/normas , Terapia Baseada em Transplante de Células e Tecidos/normas , Imunoterapia Adotiva/normas , Receptores de Antígenos Quiméricos/uso terapêutico , Linfócitos T/transplante , Transplante de Medula Óssea/métodos , Terapia Baseada em Transplante de Células e Tecidos/métodos , França , Transplante de Células-Tronco Hematopoéticas/normas , Unidades Hospitalares/organização & administração , Unidades Hospitalares/normas , Humanos , Imunoterapia Adotiva/métodos , Receptores de Antígenos Quiméricos/genética , Sociedades Médicas , Linfócitos T/fisiologia , Transplante HomólogoRESUMO
BACKGROUND: The therapeutic efficacy of bone marrow mononuclear cells (BM-MNC) autotransplantation in critical limb ischemia (CLI) has been reported. Variable proportions of circulating monocytes express low levels of CD34 (CD14+CD34lowcells) and behave in vitro as endothelial progenitor cells (EPCs). The aim of the present randomized clinical trial was to compare the safety and therapeutic effects of enriched circulating EPCs (ECEPCs) with BM-MNC administration.MethodsâandâResults:ECEPCs (obtained from non-mobilized peripheral blood by immunomagnetic selection of CD14+and CD34+cells) or BM-MNC were injected into the gastrocnemius of the affected limb in 23 and 17 patients, respectively. After a mean of 25.2±18.6-month follow-up, both groups showed significant and progressive improvement in muscle perfusion (primary endpoint), rest pain, consumption of analgesics, pain-free walking distance, wound healing, quality of life, ankle-brachial index, toe-brachial index, and transcutaneous PO2. In ECEPC-treated patients, there was a positive correlation between injected CD14+CD34lowcell counts and the increase in muscle perfusion. The safety profile was comparable between the ECEPC and BM-MNC treatment arms. In both groups, the number of deaths and major amputations was lower compared with eligible untreated patients and historical reference patients. CONCLUSIONS: This study supports previous trials showing the efficacy of BM-MNC autotransplantation in CLI patients and demonstrates comparable therapeutic efficacy between BM-MNC and EPEPCs.
Assuntos
Transplante de Medula Óssea/métodos , Células Progenitoras Endoteliais/transplante , Isquemia/terapia , Transplante Autólogo/métodos , Idoso , Amputação Cirúrgica , Células da Medula Óssea , Transplante de Medula Óssea/normas , Extremidades/patologia , Feminino , Humanos , Leucócitos Mononucleares/transplante , Masculino , Pessoa de Meia-Idade , Análise de Sobrevida , Transplante Autólogo/normasRESUMO
Choosing Wisely encourages dialogue about reducing unnecessary procedures, tests, or treatments in healthcare. The American Society for Blood and Marrow Transplantation (ASBMT) and Canadian Blood and Marrow Transplant Group (CBMTG) established a Choosing Wisely BMT Task Force whose objective was to create a list of top 5 practices in blood and marrow transplantation to be questioned. The Task Force consisted of representatives from ASBMT's Quality Outcomes, Education, and Practice Guidelines committees; ASBMT's Pharmacy Special Interest Group; CBMTG Program Directors; and Center for International Blood and Marrow Transplant Research (CIBMTR). Suggestions for current transplantation practices to question were elicited from the CBMTG Program Directors; members of ASBMT's Quality Outcomes, Practice Guidelines, and Education committees; and chairs of the CIBMTR scientific working committees. We received 119 unique suggestions that were ranked based on their potential impact on harm reduction, cost reduction, necessity of the test or practice, and the strength of available evidence. Through a modified Delphi process, suggestions were narrowed down to 6, which were then subjected to systematic reviews. The final 5 recommendations focus on graft source for patients with aplastic anemia, corticosteroid dose for initial treatment of graft-versus-host-disease, optimal number of umbilical cord blood units for transplantation, graft source in matched unrelated donor transplantation, and use of prophylactic intravenous immunoglobulin in transplant recipients. These Choosing Wisely BMT recommendations are relevant to the current clinical practice of blood and marrow transplantation and focus on tests, treatments, or procedures that may be harmful, wasteful, or for which there is no apparent clinical benefit.