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2.
Int J Hematol ; 115(5): 611-615, 2022 May.
Article in English | MEDLINE | ID: covidwho-1797499

ABSTRACT

We evaluated anti-spike protein antibody (anti-S) production in 130 hematopoietic stem cell transplant (HSCT) recipients who received the coronavirus disease-2019 vaccine. Sixty-five received allo-HSCT and 65 received auto-HSCT. Disease-specific treatments were being administered to 43.1% of allo-HSCT and 69.2% of auto-HSCT patients. Seropositivity was observed in 87.7% of allo-HSCT and 89.2% in auto-HSCT patients. Anti-S antibody production was significantly impaired in auto-HSCT patients compared with controls (178U/mL [0.4-4990.0] vs. 669 U/mL [40.3-4377.0], p < 0.001), but not in allo-HSCT patients (900 U/mL [0.4-12,893.0] vs. 860 U/mL [40.3-8988.0], P = 0.659). Clinically relevant anti-S antibody levels (> 264 U/mL) were achieved in 59.2% of patients (76.9% in allo-HSCT and 41.5% in auto-HSCT). The main factors influencing the protective level of the antibody response were the CD19 + cell count and serum immunoglobulin G levels, and these were significant in both allo-HSCT and auto-HSCT patients. Other factors included time since HSCT, complete remission status, use of immunosuppressive drugs, and levels of lymphocyte subsets including CD4, CD8 and CD56 positive cells, but these were only significant in allo-HSCT patients. Allo-HSCT patients had a relatively favorable antibody response, while auto-HSCT patients had poorer results.


Subject(s)
COVID-19 , Hematopoietic Stem Cell Transplantation , Antibody Formation , COVID-19/prevention & control , COVID-19 Vaccines , Humans , Retrospective Studies , Transplantation, Autologous , Transplantation, Homologous
3.
BMJ Open ; 12(4): e059516, 2022 04 08.
Article in English | MEDLINE | ID: covidwho-1784838

ABSTRACT

INTRODUCTION AND OBJECTIVE: Research activity was impacted by the novel COVID-19 pandemic, the PERCEPT myeloma trial was no exception. This pilot randomised trial delivered a face-to-face exercise intervention prior to and during autologous stem cell transplantation (ASCT) in myeloma patients, as a consequence of COVID-19 it required significant adaptions to continue. This brief communication describes how the previously published study protocol was adapted for virtual delivery. In addition, we highlight the challenge of continuing the study which was embedded within a clinical pathway also impacted by the pandemic. SUMMARY: The original trial protocol was amended and continued to recruit and deliver an exercise prehabilitation intervention virtually. Continued delivery of the intervention was deemed important to participants already enrolled within the trial and the adapted virtual version of the trial was acceptable to the research ethics committee as well as participants. Development of effective, remotely delivered rehabilitation and physical activity programmes are likely to benefit people living with myeloma. The COVID-19 pandemic provided an opportunity to explore the feasibility of a virtual programme for ASCT recipients, however, continued changes to the clinical pathway within which the study was embedded posed the greatest challenge and ultimately led to early termination of recruitment. TRIAL REGISTRATION NUMBER: ISRCTN15875290; pre-results.


Subject(s)
COVID-19 , Hematopoietic Stem Cell Transplantation , Multiple Myeloma , COVID-19/prevention & control , Hematopoietic Stem Cell Transplantation/methods , Humans , Multiple Myeloma/rehabilitation , Pandemics/prevention & control , Preoperative Exercise , Randomized Controlled Trials as Topic , Transplantation, Autologous
4.
Clin Lymphoma Myeloma Leuk ; 22(8): e716-e729, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1763647

ABSTRACT

INTRODUCTION: Induction therapy for multiple myeloma is traditionally capped at 6 cycles of lenalidomide due to concerns that longer treatment compromises the ability to collect sufficient stem cells for autologous stem cell transplantation (ASCT). However, during the COVID-19 pandemic, many of our patients received prolonged lenalidomide induction due to concerns about proceeding to ASCT. We investigated whether prolonged induction with lenalidomide affects the efficacy of stem cell collection among patients mobilized with cyclophosphamide and/or plerixafor. PATIENTS AND METHODS: This single center, retrospective study included patients who were treated with lenalidomide induction regimens, received mobilization with cyclophosphamide or plerixafor, and underwent apheresis in preparation for ASCT. 94 patients were included, 40 of whom received prolonged induction with >6 cycles of lenalidomide containing regimen. RESULTS: Patients who received prolonged induction were more likely to require >1 day of apheresis (38% vs. 15%; OR 3.45; P = .0154), and there was a significant correlation between the duration of lenalidomide treatment and the apheresis time required to collect sufficient cells for transplant (R2 = 0.06423, P = .0148). However, there was no significant difference between patients who received prolonged induction and those who did not with respect to CD34+ stem cell yields at completion of apheresis (9.99 vs. 10.46 cells/Kg, P = .5513) or on the first day of collection (8.29 vs. 9.59 cells/Kg, P = .1788). CONCLUSION: Among patients treated with >6 cycles of lenalidomide, mobilization augmented with cyclophosphamide and/or plerixafor will likely facilitate sufficient stem cell harvest to permit ASCT.


Subject(s)
Hematopoietic Stem Cell Transplantation , Heterocyclic Compounds , Lenalidomide , Multiple Myeloma , Benzylamines/therapeutic use , COVID-19 , Cyclams/therapeutic use , Cyclophosphamide/therapeutic use , Hematopoietic Stem Cell Mobilization/methods , Heterocyclic Compounds/pharmacology , Heterocyclic Compounds/therapeutic use , Humans , Lenalidomide/therapeutic use , Multiple Myeloma/drug therapy , Pandemics , Retrospective Studies , Transplantation, Autologous
5.
Am J Case Rep ; 23: e935142, 2022 Feb 12.
Article in English | MEDLINE | ID: covidwho-1687481

ABSTRACT

BACKGROUND SARS-CoV-2 infection or COVID-19 disease has been linked to the onset of diabetes and metabolic dysregulation because it has been suggested that viral entry proteins, specifically ACE2 and TMPRSS2, are expressed in the exocrine cells and ductal epithelium of the pancreas. Because of the unknown effect this can have on islet function, there can be doubt that patients with previous SARS-CoV-2 infections are good candidates for autologous islet transplantation after total pancreatectomy (TPAIT). CASE REPORT A patient with a history of chronic pancreatitis and previous non-surgical interventions was presented as a viable candidate for TPAIT at our institution. Approximately 1 month later, the patient contracted a SARS-CoV-2 infection, resulting in a mild case of COVID-19. The infection resolved without the need for hospitalization. At the time of this occurrence, COVID-19 was primarily considered a respiratory ailment, and little was known of the potential association between metabolic dysfunction and SARS-CoV-2. Islet isolation and surgery proceeded in a textbook manner with no surgical complications. The patient was weaned off exogenous insulin within 3 months after transplantation. CONCLUSIONS Favorable outcomes after surgery included pain reduction, islet function, and improved quality of life for the patient in the first 6 months after the procedure. These successful results demonstrate that SARS-CoV-2 infection did not prevent the patient from achieving good glucose regulation after auto-islet transplantation. This outcome suggests that, at least in this instance of mild infection, there were no long-lasting negative COVID-19-associated effects on the transplanted islets that might impact islet function.


Subject(s)
COVID-19 , Islets of Langerhans Transplantation , Humans , Pancreatectomy , Quality of Life , SARS-CoV-2 , Transplantation, Autologous
6.
Transpl Infect Dis ; 24(2): e13792, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1626964

ABSTRACT

BACKGROUND: Hematopoietic stem cell transplant (HSCT) recipients are at increased risk of mortality and morbidity with coronavirus disease 2019 (COVID-19) due to severe immune dysfunction. METHODS: A literature search was performed on PubMed, Cochrane, and Clinical trials.gov from the date of inception to 12/08/2021. We identified 19 original studies reporting data on COVID-19 in HSCT recipients after screening 292 articles. Data were extracted following preferred reporting items for systematic reviews and meta-analysis guidelines. Quality evaluation was done using the National Institutes of Health (NIH) quality assessment tool. Inter-study variance was calculated using Der Simonian-Laird Estimator. Pooled analysis was conducted using MetaXL. A random-effects model was used to estimate the proportions with 95% confidence intervals (CI). RESULTS: Of 6711 patients in 19 studies, 2031 HSCT patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection were analyzed. The median age of patients was 56.9 (range 1-81.6) years, and 63% patients were men according to 14 studies. The median time from transplant to SARS-CoV-2 infection for autologous (auto) and allogeneic (allo) HSCT patients was 23.2 (0.33-350.5) months and 16.4 (0.2-292.7) months, respectively. The median follow-up time after COVID-19 diagnosis was 28 (0-262) days. The COVID-19 mortality rate was 19% (95% CI 0.15-0.24, I2  = 76%, n = 373/2031). The pooled mortality rate was 17% (95% CI 0.12-0.24, I2  = 78%, n = 147/904) in auto-HSCT patients and 21% (95% CI 0.16-0.25, I2  = 60%, n = 231/1103) in allo-HSCT patients. CONCLUSIONS: HSCT recipients have a high risk of mortality and clinical complications due to COVID-19. There is a need for ongoing vigilance, masks, and social distancing, vaccination, and aggressive management of SARS-CoV-2 infection in HSCT recipients.


Subject(s)
COVID-19 , Hematopoietic Stem Cell Transplantation , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , COVID-19 Testing , Child , Child, Preschool , Hematopoietic Stem Cell Transplantation/adverse effects , Humans , Infant , Male , Middle Aged , SARS-CoV-2 , Transplant Recipients , Transplantation, Autologous , Young Adult
8.
Acta Neurol Scand ; 145(1): 119-122, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1570446

ABSTRACT

BACKGROUND: Mesenchymal stem cells are expected to have a therapeutic effect on progressive neurodegenerative diseases for which there is currently no fundamental treatment. AIMS OF THE STUDY: The aim is to confirm that repeated infusion of autologous adipose tissue-derived stem cells (ADSCs) can be safely administered to patients with Parkinson's disease, and to investigate the effects of this as a pilot study. METHODS: Three patients with Parkinson's disease received five or six repeated infusions of ADSCs at intervals of approximately one month. Observations were based on medical examinations by a neurologist and interviews with the patient and caregivers. The severity of Parkinson's disease was assessed using the Hoehn & Yahr staging scale and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). RESULTS: No adverse events were observed during the observation period from the start of treatment to six months after the end of the last dose. MDS-UPDRS improved in all three patients. CONCLUSIONS: Repeated administration of Autologous ADSCs for Parkinson's disease was safe and feasible. The results of this pilot study provide insight into the value of further research.


Subject(s)
Parkinson Disease , Adipose Tissue , Humans , Parkinson Disease/therapy , Pilot Projects , Stem Cells , Transplantation, Autologous
9.
N Engl J Med ; 385(24): 2264-2270, 2021 12 09.
Article in English | MEDLINE | ID: covidwho-1560911

ABSTRACT

Inherited junctional epidermolysis bullosa is a severe genetic skin disease that leads to epidermal loss caused by structural and mechanical fragility of the integuments. There is no established cure for junctional epidermolysis bullosa. We previously reported that genetically corrected autologous epidermal cultures regenerated almost an entire, fully functional epidermis on a child who had a devastating form of junctional epidermolysis bullosa. We now report long-term clinical outcomes in this patient. (Funded by POR FESR 2014-2020 - Regione Emilia-Romagna and others.).


Subject(s)
Epidermis/transplantation , Epidermolysis Bullosa, Junctional/therapy , Keratinocytes/transplantation , Transduction, Genetic , Transgenes , Cell Self Renewal , Cells, Cultured/transplantation , Child , Clone Cells , Epidermis/pathology , Epidermolysis Bullosa, Junctional/genetics , Epidermolysis Bullosa, Junctional/pathology , Follow-Up Studies , Genetic Diseases, Inborn/pathology , Genetic Diseases, Inborn/therapy , Genetic Therapy , Genetic Vectors , Humans , Keratinocytes/cytology , Keratinocytes/physiology , Male , Regeneration , Stem Cells/physiology , Transplantation, Autologous
10.
N Engl J Med ; 385(21): 1929-1940, 2021 11 18.
Article in English | MEDLINE | ID: covidwho-1526127

ABSTRACT

BACKGROUND: Allogeneic hematopoietic stem-cell transplantation is the standard of care for Hurler syndrome (mucopolysaccharidosis type I, Hurler variant [MPSIH]). However, this treatment is only partially curative and is associated with complications. METHODS: We are conducting an ongoing study involving eight children with MPSIH. At enrollment, the children lacked a suitable allogeneic donor and had a Developmental Quotient or Intelligence Quotient score above 70 (i.e., none had moderate or severe cognitive impairment). The children received autologous hematopoietic stem and progenitor cells (HSPCs) transduced ex vivo with an α-L-iduronidase (IDUA)-encoding lentiviral vector after myeloablative conditioning. Safety and correction of blood IDUA activity up to supraphysiologic levels were the primary end points. Clearance of lysosomal storage material as well as skeletal and neurophysiological development were assessed as secondary and exploratory end points. The planned duration of the study is 5 years. RESULTS: We now report interim results. The children's mean (±SD) age at the time of HSPC gene therapy was 1.9±0.5 years. At a median follow-up of 2.10 years, the procedure had a safety profile similar to that known for autologous hematopoietic stem-cell transplantation. All the patients showed prompt and sustained engraftment of gene-corrected cells and had supraphysiologic blood IDUA activity within a month, which was maintained up to the latest follow-up. Urinary glycosaminoglycan (GAG) excretion decreased steeply, reaching normal levels at 12 months in four of five patients who could be evaluated. Previously undetectable levels of IDUA activity in the cerebrospinal fluid became detectable after gene therapy and were associated with local clearance of GAGs. Patients showed stable cognitive performance, stable motor skills corresponding to continued motor development, improved or stable findings on magnetic resonance imaging of the brain and spine, reduced joint stiffness, and normal growth in line with World Health Organization growth charts. CONCLUSIONS: The delivery of HSPC gene therapy in patients with MPSIH resulted in extensive metabolic correction in peripheral tissues and the central nervous system. (Funded by Fondazione Telethon and others; ClinicalTrials.gov number, NCT03488394; EudraCT number, 2017-002430-23.).


Subject(s)
Genetic Therapy , Hematopoietic Stem Cell Transplantation , Iduronidase/metabolism , Mucopolysaccharidosis I/therapy , Child, Preschool , Female , Follow-Up Studies , Genetic Vectors , Glycosaminoglycans/urine , Humans , Iduronidase/deficiency , Iduronidase/genetics , Infant , Lentivirus , Male , Mucopolysaccharidosis I/metabolism , Mutation , Stem Cell Transplantation , Transplantation, Autologous
13.
J Plast Reconstr Aesthet Surg ; 75(1): 112-117, 2022 01.
Article in English | MEDLINE | ID: covidwho-1458637

ABSTRACT

INTRODUCTION: COVID-19 has disrupted the provision of breast reconstructive services throughout the UK. Autologous free flap breast reconstruction was restarted in our unit on 3 June 2020. We aimed to compare the unit's performance of microsurgical autologous breast reconstruction in the "post-COVID" period compared with the exact time period in the preceding year. METHODS: We retrospectively reviewed prospectively collected data in the "pre-COVID" (from 3 June 2019 to 31 December 2019) and "post-COVID" period (from 3 June 2020 to 31 December 2020). Patient demographics included age, body mass index, co-morbidities, Anaesthesiologists (ASA) grade and smoking status. Surgical factors included neoadjuvant chemotherapy, previous chest wall radiotherapy, unilateral or bilateral reconstruction, reconstruction timing, number of pedicles, contralateral symmetrisation and other procedures. dependant variables were ischaemic time, operative time, mastectomy weight, flap weight, length of stay, return to theatre and complication rates. The number of trainers and trainees present in theatre was recorded and analysed. RESULTS: Fewer DIEP flaps were performed in the "post-COVID" period (45 vs. 29). No significant difference was observed in mastectomy resection weight, but flap weight was significantly increased. No significant difference was found in ischaemic time as well. The postoperative length of stay was significantly reduced. No significant difference was found in rates of return to theatre, unplanned admission, infection, haematoma, seroma or wound dehiscence. No cases of venous thromboembolism or flap failures were recorded. The mean number of trainers and trainees, and the trainee-to-trainer ratio was not found to be significantly different between cohorts. CONCLUSION: Although fewer cases were performed, autologous breast reconstruction was safely delivered throughout the COVID-19 pandemic in the first wave without affecting training.


Subject(s)
Breast Neoplasms/surgery , COVID-19/epidemiology , Free Tissue Flaps/transplantation , Mammaplasty/methods , Microsurgery/methods , Female , Humans , Length of Stay/statistics & numerical data , Mastectomy , Middle Aged , Pandemics , Retrospective Studies , SARS-CoV-2 , Transplantation, Autologous , United Kingdom/epidemiology
15.
Int J Hematol ; 115(1): 61-68, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1432631

ABSTRACT

BACKGROUND: "Hospital-at-home" (HAH) programs have been shown to optimize resource utilization, shorten hospitalization and prevent nosocomial infection. METHODS: We retrospectively analysed data regarding implementation of an HAH unit for caring patients with hematological malignancies in our center, during the COVID-19 pandemic. RESULTS: Between January and November 2020, 105 patients were treated in the HAH unit for a total of 204 episodes. Nine patients with multiple myeloma (MM) received autologous HSCT (auto-HSCT). Three patients with acute myeloid leukemia (AML) received consolidation therapy, 32 patients underwent clinical and analytical monitoring, 20 were transplant recipients early discharged (5 auto-HSCT and 15 allo-HSCT) and 2 had received CART cells therapy. Azacitidine, bortezomib and carfilzomib were administered at home to 54 patients with AML, myelodysplastic syndrome (MDS) or MM. A median of 17 (IQR 13-19) days of admission per patient and a total of 239 visits to the Hematology day-care hospital were avoided. Overall, 28 patients (14% of all episodes) needed admission to the hospital, 4 of them due to COVID-19. CONCLUSIONS: Implementation of a Hematology HAH unit was feasible and safe, and provided thorough advanced care to a high-risk population. Advanced care-at-home strategies can be crucial during times of COVID-19 to minimize treatment interruptions and reduce the risk of cross-infections.


Subject(s)
COVID-19 , Continuity of Patient Care , Hematologic Neoplasms/therapy , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , Disease Management , Feasibility Studies , Female , Hematopoietic Stem Cell Transplantation , Hospitalization , Humans , Leukemia, Myeloid, Acute/therapy , Male , Middle Aged , Multiple Myeloma/therapy , Myelodysplastic Syndromes/therapy , Retrospective Studies , Transplantation, Autologous , Young Adult
20.
Medicine (Baltimore) ; 100(33): e26978, 2021 Aug 20.
Article in English | MEDLINE | ID: covidwho-1367078

ABSTRACT

BACKGROUND: The novel coronavirus disease 2019 (COVID-19) has changed people's way of life and posed great challenges to plastic surgery. Most of plastic surgeries are considered elective surgeries and are recommended to be delayed. But breast reconstruction in plastic surgery is special. Doctors' associations from different countries have different rules on whether breast reconstruction surgery should be delayed. For the controversial topic of immediate breast reconstruction in the COVID-19 pandemic, we conducted this study. METHODS: We searched English databases such as PubMed, Cochrane Library, and Embase. The publication time of papers was set to be from the establishment of the databases to February 2021. All studies on immediate breast reconstruction in the COVID-19 pandemic were included in our study. RESULTS: A total of 6 studies were included in this study. Four studies recommended the use of breast implants or tissue expansion for breast reconstruction surgery and had good results in their clinical practice. In addition, 1 study planned to use autologous free tissue transfer for breast reconstruction, and 1 study planned to use microsurgical techniques for breast reconstruction. But these 2 technologies are still in the planning stage and have not yet been implemented. CONCLUSIONS: In our opinion, breast cancer surgery belongs to confine operation, and breast reconstruction surgery should be performed immediately after the completion of breast cancer surgery. We recommend the use of breast implants for breast reconstruction surgery during the COVID-19 epidemic. Due to the limitations of the study, our proposed protocol for breast reconstruction surgery during the COVID-19 epidemic needs to be further validated in clinical studies.


Subject(s)
COVID-19/epidemiology , Mammaplasty , Pandemics , Time-to-Treatment , Adipose Tissue/transplantation , Breast Implants , Breast Neoplasms/surgery , Female , Humans , Mammaplasty/methods , Mastectomy , Microsurgery , SARS-CoV-2 , Tissue Expansion Devices , Transplantation, Autologous
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