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Article ; Online: How to optimize outcome of patients undergoing HLA-matched related haematopoietic stem cell transplantation in acquired and inherited bone marrow failure syndromes.

Giardino, Stefano / Pierri, Filomena / Faraci, Maura

2023 Volume 203, Issue 2, Page(s) 158–160

Abstract: Up-front allogeneic haematopoietic stem cell transplantation (allo-HSCT) after a reduced intensity conditioning regimen is the standard treatment in children with acquired severe aplastic anaemia (aSAA) and inherited bone marrow failure syndromes (iBMFs) ...

Abstract	Up-front allogeneic haematopoietic stem cell transplantation (allo-HSCT) after a reduced intensity conditioning regimen is the standard treatment in children with acquired severe aplastic anaemia (aSAA) and inherited bone marrow failure syndromes (iBMFs) in the presence of a healthy matched related donor (MRD). The paper by Alsultan et al. report the safety and efficacy of MRD HSCT conditioned with low-dose cyclophosphamide, fludarabine and thymoglobulin in both aSAA and non-Fanconi iBMFs, strengthening the concept of the pivotal role of immunosuppressive approach in allo-HSCT for specific subgroups of non-malignant diseases requiring a reduced risk of toxicities, offering the opportunity to discuss the essential points for achieving patients' long-term survival after MRD HSCT in BMF. Commentary on: Alsultan et al. Human leucocyte antigen-matched related haematopoietic stem cell transplantation using low-dose cyclophosphamide, fludarabine and thymoglobulin in children with severe aplastic anaemia. Br J Haematol 2023;203:255-263.
Language	English
Publishing date	2023-08-16
Publishing country	England
Document type	Journal Article
ZDB-ID	80077-6
ISSN	1365-2141 ; 0007-1048
ISSN (online)	1365-2141
ISSN	0007-1048
DOI	10.1111/bjh.19047
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Article ; Online: Association between oral and fecal microbiome dysbiosis and treatment complications in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation.

Faraci, M / Bonaretti, C / Dell'Orso, G / Pierri, F / Giardino, S / Angiero, F / Blasi, S / Farronato, G / Di Marco, E / Trevisiol, A / Olcese, E / Rufino, L / Squillario, M / Biassoni, R

Scientific reports

2024 Volume 14, Issue 1, Page(s) 6708

Abstract: The oral and gastrointestinal mucosae represent the main targets of the toxic effect of chemo and/or radiotherapy administered during the conditioning regimen before hematopoietic stem cell transplant (HSCT). These harmful consequences and the ... ...

Abstract	The oral and gastrointestinal mucosae represent the main targets of the toxic effect of chemo and/or radiotherapy administered during the conditioning regimen before hematopoietic stem cell transplant (HSCT). These harmful consequences and the immunological complications that may occur after the transplant (such as Graft versus Host Disease, GvHD) are responsible for the clinical symptoms associated with mucositis during the aplasia phase, like pain, nausea, vomiting, and diarrhea. These toxicities could play a critical role in the oral and gastrointestinal microbiomes during the post-transplant phase, and the degree of microbial dysbiosis and dysregulation among different bacterial species could also be crucial in intestinal mucosa homeostasis, altering the host's innate and adaptive immune responses and favoring abnormal immune responses responsible for the occurrence of GvHD. This prospective pediatric study aims to analyze longitudinally oral and gut microbiomes in 17 pediatric patients who received allogeneic HSCT for malignant and non-malignant diseases. The oral mucositis was mainly associated with an increased relative abundance of Fusobacteria, and Prevotella species, while Streptococcus descendants showed a negative correlation. The fecal microbiome of subjects affected by cutaneous acute GvHD (aGvHD) correlated with Proteobacteria. Oral mucosal microbiota undergoes changes after HSCT, Fusobacteria, and Prevotella represent bacterial species associated with mucositis and they could be the target for future therapeutic approaches, while fecal microbiome in patients with acute GvHD (aGvHD) revealed an increase of different class of Proteobacteria (Alphaproteobacteria and Deltaproteobacteria) and a negative correlation with the class of Gammaproteobacteria.
MeSH term(s)	Humans ; Child ; Mucositis/etiology ; Dysbiosis/etiology ; Prospective Studies ; Microbiota ; Graft vs Host Disease ; Bacteria ; Hematopoietic Stem Cell Transplantation/adverse effects
Language	English
Publishing date	2024-03-20
Publishing country	England
Document type	Journal Article
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-024-55690-6
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Article ; Online: Hematopoietic stem cell transplantation for classical inherited bone marrow failure syndromes: an update.

Pierri, Filomena / Faraci, Maura / Giardino, Stefano / Dufour, Carlo

Expert review of hematology

2021 Volume 14, Issue 10, Page(s) 911–925

Abstract: Introduction: Inherited bone marrow failure syndromes (IBMFS) feature complex molecular pathophysiology resulting in ineffective hematopoiesis and increased risk of progression to myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). ... ...

Abstract	Introduction: Inherited bone marrow failure syndromes (IBMFS) feature complex molecular pathophysiology resulting in ineffective hematopoiesis and increased risk of progression to myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Allogenic hematopoietic stem cell transplantation (HSCT) is the only well-established cure for the hematological manifestations of these diseases. Areas covered: In recent years, analysis of large series from international databases (mainly from the European Bone Marrow Transplantation [EBMT] database) has improved knowledge about HSCT in IBMFS. This review, following a thorough Medline search of the pertinent published studies, reports the most recent data on HSCT in IBMFS. Expert opinion: Despite the common features, IBMFS are very different in their manifestations and in the occurrence and management of HSCT complications. Thus, a 'disease-specific' HSCT using an optimized conditioning regimen based on the characteristics of the disease is essential for achieving long-term survival. The phenotypical heterogeneity associated with extramedullary abnormalities has to be carefully evaluated before HSCT because transplantation may only correct impaired hematopoiesis. HSCT may be associated with the risk of treatment-related mortality and with significant early and late morbidity. For these reasons, the benefits should be carefully weighed against the risks.
MeSH term(s)	Congenital Bone Marrow Failure Syndromes ; Hematopoietic Stem Cell Transplantation/adverse effects ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Leukemia, Myeloid, Acute/etiology ; Myelodysplastic Syndromes/genetics ; Myelodysplastic Syndromes/therapy ; Transplantation Conditioning/methods
Language	English
Publishing date	2021-09-15
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2516804-6
ISSN	1747-4094 ; 1747-4086
ISSN (online)	1747-4094
ISSN	1747-4086
DOI	10.1080/17474086.2021.1977119
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Article ; Online: Autoimmune diseases after allogeneic stem cell transplantation: a clinician's guide and future outlook.

Faraci, Maura / Dell'Orso, Gianluca / Giardino, Stefano / Pierri, Filomena

Expert review of clinical immunology

2022 , Page(s) 1–14

Abstract: Introduction: Autoimmune disease (AD) may occur after allogeneic hematopoietic stem cell transplantation (HSCT). The autoimmune mechanism seems to be related to an imbalance of the immune regulation effect of T-regulatory lymphocytes on autoreactive T- ... ...

Abstract	Introduction: Autoimmune disease (AD) may occur after allogeneic hematopoietic stem cell transplantation (HSCT). The autoimmune mechanism seems to be related to an imbalance of the immune regulation effect of T-regulatory lymphocytes on autoreactive T-lymphocytes. Areas covered: ADs include hematological ADs (HADs) and nonhematologic ADs (NHADs) involving organs such as thyroid, peripheral and central nervous system, skin, liver, connective tissue, gastrointestinal tract, and kidney. To identify the risk factors for ADs, to report their clinical characteristics, and to discuss new approaches represent the areas covered in this review. Expert opinion: Some risk factors for HAD and NHAD are common and include nonmalignant diseases, young age, cord blood as a stem cell source, conditioning regimens without total body irradiation, alemtuzumab, antithymocyte globulin, T-cell-depleted transplant, some viral infection, mixed chimerism, and chronic Graft versus Host Disease. In NHADs, the detection of autoantibodies is more frequent and the transfer of autoimmunity from the donor to the recipient represents the pathogenetic mechanism responsible for these complications. New therapeutic approaches such as bortezomib, daratumumab, sirolimus, eculizumab, and eltrombopag appear to be promising in terms of better efficacy and reduced toxicity compared to traditional therapies. New horizons based on personalized therapies will allow us to improve the prognosis of AD.
Language	English
Publishing date	2022-05-12
Publishing country	England
Document type	Journal Article
ZDB-ID	2274260-8
ISSN	1744-8409 ; 1744-666X
ISSN (online)	1744-8409
ISSN	1744-666X
DOI	10.1080/1744666X.2022.2072299
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Article: Development and Validation of a Novel LC-MS/MS Method for a TDM-Guided Personalization of HSCT Conditioning with High-Dose Busulfan in Children.

Cafaro, Alessia / Pigliasco, Federica / Baiardi, Giammarco / Barco, Sebastiano / Stella, Manuela / Bandettini, Roberto / Mattioli, Francesca / Faraci, Maura / Cangemi, Giuliana

Biomedicines

2023 Volume 11, Issue 2

Abstract: Personalization of busulfan (Bu) exposure via therapeutic drug monitoring (TDM) is recommended for patients treated with high-dose conditioning regimens. Several laboratories' developed methods are available in the literature with a lack of ... ...

Abstract	Personalization of busulfan (Bu) exposure via therapeutic drug monitoring (TDM) is recommended for patients treated with high-dose conditioning regimens. Several laboratories' developed methods are available in the literature with a lack of standardization. The aim of this study is to develop a new standardized LC-MS/MS method and validate it according to the international ICH M10 (EMA) guidelines. Our method is based on rapid protein precipitation from 50 µL plasma followed by separation on a reversed-phase C-18 UHPLC column after the addition of deuterated internal standard and has been tested on real samples from pediatric patients treated with myeloablative conditioning regimens, including Bu, before autologous or allogeneic hematopoietic stem cell transplantation (HSCT). The validated LC-MS/MS method is linear over wide concentration ranges (125-2000 ng/mL), accurate, and reproducible in the absence of matrix effects, allowing for the specific and rapid quantification of Bu and allowing next-dose recommendations to be made in a timely fashion to answer clinicians' needs. Given the lack of data on the stability of Bu in real clinical samples, stability was assessed both on quality controls and on real samples to set up a robust protocol in real-life conditions. This novel LC-MS/MS method is suitable for application to the TDM-guided personalization of conditioning treatments with high-dose busulfan in pediatric patients undergoing HSCT.
Language	English
Publishing date	2023-02-11
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2720867-9
ISSN	2227-9059
ISSN	2227-9059
DOI	10.3390/biomedicines11020530
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Article ; Online: Endoscopic Approach in the Diagnosis of Gastrointestinal Acute Graft Versus Host Disease in Children.

Faraci, Maura / Giardino, Stefano / Madeo, Annalisa / Coccia, Cristina / Arrigo, Serena / Pierri, Filomena / Gandullia, Paolo

JPGN reports

2022 Volume 3, Issue 1, Page(s) e163

Abstract: The objectives of this study were to describe clinical, histological, and endoscopic findings in children undergoing gastrointestinal (GI) endoscopy for symptoms of digestive acute graft-versus-host disease (a-GvHD), to evaluate the rate of steroid- ... ...

Abstract	The objectives of this study were to describe clinical, histological, and endoscopic findings in children undergoing gastrointestinal (GI) endoscopy for symptoms of digestive acute graft-versus-host disease (a-GvHD), to evaluate the rate of steroid-resistant GvHD and transplant-related mortality, and to describe the feasibility and safety of the endoscopic procedure. Methods: This was a retrospective study conducted, at the IRCSS Istituto G. Gaslini in Genova, Italy, in 26 children undergoing upper or lower GI endoscopy after allogeneic hematopoietic stem cell transplantation between 2000 and 2017. Results: Histology confirmed a diagnosis of a-GvHD in 73% of patients; it was frequently associated with steroid-resistant a-GvHD ( Conclusions: In our experience, the endoscopic approach in the diagnosis of GI a-GvHD in children was feasible and safe. Furthermore, the histological diagnosis of GI a-GvHD was associated with an increased risk of steroid-resistant GvHD and with high transplant-related mortality.
Language	English
Publishing date	2022-01-24
Publishing country	United States
Document type	Journal Article
ISSN	2691-171X
ISSN (online)	2691-171X
DOI	10.1097/PG9.0000000000000163
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Article ; Online: Long-Term Complications after Allogeneic Hematopoietic Stem Cell Transplantation with Treosulfan- or Busulfan-Based Conditioning in Pediatric Patients with Acute Leukemia or Myelodysplastic Syndrome: Results of an Associazione Italiana Ematologia Oncologia Pediatrica Retrospective Study.

Saglio, Francesco / Pagliara, Daria / Zecca, Marco / Balduzzi, Adriana / Cattoni, Alessandro / Prete, Arcangelo / Tambaro, Francesco Paolo / Faraci, Maura / Calore, Elisabetta / Locatelli, Franco / Fagioli, Franca

Transplantation and cellular therapy

2024 Volume 30, Issue 4, Page(s) 433.e1–433.e10

Abstract: Patients undergoing hematopoietic stem cell transplantation (HSCT) for hematologic malignancies during childhood have an increased risk of developing long-term sequelae that are in part attributable to the conditioning regimen. The present study aimed to ...

Abstract	Patients undergoing hematopoietic stem cell transplantation (HSCT) for hematologic malignancies during childhood have an increased risk of developing long-term sequelae that are in part attributable to the conditioning regimen. The present study aimed to assess the occurrence of long-term toxicities in a population of children who underwent HSCT for hematologic malignancies using either treosulfan or busulfan in the conditioning regimen. The cumulative incidences of growth impairment, altered gonadal function, altered thyroid function, cataracts, secondary malignant neoplasia, and altered pulmonary function were evaluated retrospectively by univariable and multivariable analyses in a population of 521 pediatric patients with acute leukemias or myelodysplastic syndromes treated in 20 Italian transplant centers affiliated with the Associazione Italiana Ematologia ed Oncologia Pediatrica (AIEOP). The median duration of follow-up for the entire study population was 7.1 years (range, 1 to 16 years). Overall, a larger proportion of patients given busulfan developed long-term toxicities compared to patients treated with treosulfan (34% versus 20%; P = .01). In univariable analysis, gonadal toxicity developed in 10% of patients who received treosulfan (95% confidence interval [CI], 3% to 15%), compared with 38% (95% CI, 24% to 39%) of busulfan-treated patients (P = .02), and this finding was confirmed by multivariable analysis (relative risk, .51; 95% CI, .34 to .76; P = .0009). We did not find any statistically significant associations between the occurrence of other long-term toxicities and the use of either busulfan or treosulfan. This study provides evidence that the use of treosulfan is correlated with a reduced incidence of gonadal toxicity in children undergoing HSCT for hematologic malignancies.
MeSH term(s)	Humans ; Child ; Busulfan/adverse effects ; Busulfan/analogs & derivatives ; Retrospective Studies ; Transplantation Conditioning/adverse effects ; Transplantation Conditioning/methods ; Hematopoietic Stem Cell Transplantation/adverse effects ; Hematopoietic Stem Cell Transplantation/methods ; Leukemia, Myeloid, Acute/therapy ; Myelodysplastic Syndromes/therapy ; Hematologic Neoplasms
Chemical Substances	treosulfan (CO61ER3EPI) ; Busulfan (G1LN9045DK)
Language	English
Publishing date	2024-01-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	3062231-1
ISSN	2666-6367
ISSN (online)	2666-6367
DOI	10.1016/j.jtct.2023.12.671
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Article ; Online: High-precision and cost-efficient sequencing for real-time COVID-19 surveillance.

Park, Sung Yong / Faraci, Gina / Ward, Pamela M / Emerson, Jane F / Lee, Ha Youn

Scientific reports

2021 Volume 11, Issue 1, Page(s) 13669

Abstract: COVID-19 global cases have climbed to more than 33 million, with over a million total deaths, as of September, 2020. Real-time massive SARS-CoV-2 whole genome sequencing is key to tracking chains of transmission and estimating the origin of disease ... ...

Abstract	COVID-19 global cases have climbed to more than 33 million, with over a million total deaths, as of September, 2020. Real-time massive SARS-CoV-2 whole genome sequencing is key to tracking chains of transmission and estimating the origin of disease outbreaks. Yet no methods have simultaneously achieved high precision, simple workflow, and low cost. We developed a high-precision, cost-efficient SARS-CoV-2 whole genome sequencing platform for COVID-19 genomic surveillance, CorvGenSurv (Coronavirus Genomic Surveillance). CorvGenSurv directly amplified viral RNA from COVID-19 patients' Nasopharyngeal/Oropharyngeal (NP/OP) swab specimens and sequenced the SARS-CoV-2 whole genome in three segments by long-read, high-throughput sequencing. Sequencing of the whole genome in three segments significantly reduced sequencing data waste, thereby preventing dropouts in genome coverage. We validated the precision of our pipeline by both control genomic RNA sequencing and Sanger sequencing. We produced near full-length whole genome sequences from individuals who were COVID-19 test positive during April to June 2020 in Los Angeles County, California, USA. These sequences were highly diverse in the G clade with nine novel amino acid mutations including NSP12-M755I and ORF8-V117F. With its readily adaptable design, CorvGenSurv grants wide access to genomic surveillance, permitting immediate public health response to sudden threats.
MeSH term(s)	COVID-19/diagnosis ; COVID-19/virology ; COVID-19 Nucleic Acid Testing ; Genome, Viral ; High-Throughput Nucleotide Sequencing ; Humans ; Mutation ; SARS-CoV-2/genetics ; SARS-CoV-2/isolation & purification ; Sequence Analysis, RNA ; Whole Genome Sequencing
Language	English
Publishing date	2021-07-01
Publishing country	England
Document type	Journal Article
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-021-93145-4
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Article ; Online: Impact of allogeneic stem cell transplantation on thyroid function.

Felicetti, F / Gatti, F / Faraci, D / Rosso, D / Zavattaro, M / Fortunati, N / Marinelli, L / Leone, S / Gill, J / Dionisi-Vici, M / Dellacasa, C / Busca, A / Giaccone, L / Arvat, E / Bruno, B / Brignardello, E

Journal of endocrinological investigation

2023 Volume 46, Issue 9, Page(s) 1825–1834

Abstract: ... eighty-six patients (M 104; F 82; median age 53.4 years) who underwent allo-SCT between January 2010 and ...

Abstract	Purpose: Primary hypothyroidism is a main endocrine complication after allogeneic stem cells transplantation (allo-SCT) in children, but in adults data on post-SCT hypothyroidism are limited. The aims of this observational, cross-sectional study were to assess the prevalence of hypothyroidism in adult allo-SCT recipients according to time from transplantation, and to identify risk factors. Methods: One hundred and eighty-six patients (M 104; F 82; median age 53.4 years) who underwent allo-SCT between January 2010 and December 2017 were enrolled and divided into three groups, according to time from allo-SCT (1-3 years; 3-5 years; > 5 years). Pre-transplant TSH and fT4 levels were available for all patients. After transplantation, TSH, fT4 and anti-thyroperoxidase antibodies (TPO-Ab) were evaluated. Results: After a follow-up of 3.7 years, 34 (18.3%) patients developed hypothyroidism, with higher prevalence in females (p < 0.001) and in patients who received matched unrelated donor grafts (p < 0.05). No difference in prevalence was found at different time points. Patients who developed hypothyroidism showed higher rate of TPO-Ab positivity (p < 0.05) and higher pre-transplant TSH levels (median 2.34 µU/ml) compared to those with preserved thyroid function (median 1.53 µU/ml; p < 0.001). Multivariable analysis identified higher pre-transplant TSH levels as a positive predictor of hypothyroidism (p < 0.005). The ROC curve analysis identified a pre-SCT TSH cutoff of 1.84 µU/ml, which can predict hypothyroidism with sensitivity 74.1% and specificity 67.2%. Conclusions: About one out of four patients developed hypothyroidism after allo-SCT, with a greater incidence in females. Pre-transplant TSH levels seem to predict the onset of post-SCT hypothyroidism.
MeSH term(s)	Adult ; Child ; Female ; Humans ; Middle Aged ; Cross-Sectional Studies ; Transplantation, Homologous/adverse effects ; Hematopoietic Stem Cell Transplantation/adverse effects ; Hypothyroidism/epidemiology ; Hypothyroidism/etiology ; Thyrotropin
Chemical Substances	Thyrotropin (9002-71-5)
Language	English
Publishing date	2023-03-08
Publishing country	Italy
Document type	Observational Study ; Journal Article
ZDB-ID	432272-1
ISSN	1720-8386 ; 0391-4097 ; 1121-1369
ISSN (online)	1720-8386
ISSN	0391-4097 ; 1121-1369
DOI	10.1007/s40618-023-02039-x
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Article ; Online: Major Abdominal Surgery for Pediatric Crohn's Disease in the Anti-TNF Era: 10-Year Analysis of Data From the IBD Registry of Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition.

Alvisi, Patrizia / Faraci, Simona / Scarallo, Luca / Congiu, Marco / Bramuzzo, Matteo / Illiceto, Maria Teresa / Arrigo, Serena / Romano, Claudio / Zuin, Giovanna / Miele, Erasmo / Gatti, Simona / Aloi, Marina / Renzo, Sara / Caldaro, Tamara / Labriola, Flavio / De Angelis, Paola / Lionetti, Paolo

Inflammatory bowel diseases

2024

Abstract: Background: The natural history of Crohn's disease (CD) can result in complications requiring surgery. Pediatric data are scarce about major abdominal surgery. The IBD Registry from the Italian Society of Pediatric Gastroenterology, Hepatology, and ... ...

Abstract	Background: The natural history of Crohn's disease (CD) can result in complications requiring surgery. Pediatric data are scarce about major abdominal surgery. The IBD Registry from the Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition has been active since 2008 and collects data from major pediatric IBD centers in Italy. The aim of the present report was to explore the prevalence of major abdominal surgery among children affected by CD in an era when antitumor necrosis factor (anti-TNF-α) agents were already used so that we might appraise the incidence of surgical-related complications and identify the factors associated with postoperative disease recurrence. Methods: We retrospectively analyzed data from patients enrolled in the registry from January 2009 to December 2018. Patients with monogenic IBD and patients undergoing surgery for perianal disease were excluded. Results: In total, 135 of 1245 patients were identified. We report the prevalence of major abdominal surgery of 10.8%. Pediatric surgeons performed the procedure in 54.1% of cases, and a laparoscopic approach was used in 47.4% of surgical procedures. Seventeen patients (12.6%) experienced a total of 21 early postoperative complications, none of which was severe. A laparoscopic approach was the only factor negatively associated with the occurrence of postoperative complications (odds ratio, 0.22; 95% confidence interval, 0.06-0.8; P = .02). Fifty-four (40%) patients experienced postoperative endoscopic recurrence, and 33 (24.4%) of them experienced postoperative clinical recurrence. The postoperative treatment with anti-TNF-α drugs was significantly associated with a reduced risk of endoscopic recurrence (odds ratio, 0.19; 95% confidence interval, 0.05-0.79; P = .02). Conclusion: In our cohort, the overall prevalence of major abdominal surgery was low, as well as the rate of surgical-related complications. Postoperative anti-TNF-α therapy seems be protective against endoscopic recurrence.
Language	English
Publishing date	2024-01-05
Publishing country	England
Document type	Journal Article
ZDB-ID	1340971-2
ISSN	1536-4844 ; 1078-0998
ISSN (online)	1536-4844
ISSN	1078-0998
DOI	10.1093/ibd/izad310
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