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2.
Infect Control Hosp Epidemiol ; 41(9): 1066-1067, 2020 09.
Article in English | MEDLINE | ID: covidwho-2096295

ABSTRACT

With concerns for presymptomatic transmission of COVID-19 and increasing burden of contact tracing and employee furloughs, several hospitals have supplemented pre-existing infection prevention measures with universal masking of all personnel in hospitals. Other hospitals are currently faced with the dilemma of whether or not to proceed with universal masking in a time of critical mask shortages. We summarize the rationale behind a universal masking policy in healthcare settings, important considerations before implementing such a policy and the challenges with universal masking. We also discusses proposed solutions such as universal face shields.


Subject(s)
Betacoronavirus , Coronavirus Infections/epidemiology , Pandemics , Pneumonia, Viral , COVID-19 , Humans , Prospective Studies , SARS-CoV-2 , Stem Cell Transplantation
3.
Cell Prolif ; 55(8): e13217, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1985750

ABSTRACT

BACKGROUND: Clinical researches of stem cell-based therapies are highly active in China, while it was arduous to determine the most effective way of clinical translation of those advanced therapies. METHODS: This article briefly introduced the regulatory framework development, the progress in stem cell clinical researches and clinical trials of commercially developed stem cell-based products, as well as the clinical review concerns of stem cell-based products in China. MAIN FINDINGS: The current regulatory framework of stem cell clinical researches in China was launched in 2015, when regulatory authorities issued "Administrative Measures on Stem Cell Clinical Research" (AMSCCR) detailing the rules of stem cell clinical research. Thereafter, the rapidly growing stem cell clinical researches were rigorously managed and clinical use of stem cell therapy was halted. Meanwhile, commercially developed stem cell-based products are supervised by Drug Administration Law (DAL). CONCLUSION: The regulatory framework of stem cell-based therapy in China has progressed in the last few decades, which is currently regulated according to AMSCCR and DAL. Well-designed and patient-focused clinical trial is required for commercially developed stem cell-based products, and definite clinical benefit evidence is crucial to obtain marketing authorization.


Subject(s)
Stem Cell Transplantation , China , Humans
5.
PLoS One ; 17(7): e0271756, 2022.
Article in English | MEDLINE | ID: covidwho-1974320

ABSTRACT

To assess morbidity and mortality of parainfluenza virus (PIV) infections in immunocompromised patients, we analysed PIV infections in a hematology and stem cell transplantation (SCT) unit over the course of three years. Isolated PIV strains were characterized by sequence analysis and nosocomial transmission was assessed including phylogenetic analysis of viral strains. 109 cases of PIV infection were identified, 75 in the setting of SCT. PIV type 3 (n = 68) was the most frequent subtype. PIV lower respiratory tract infection (LRTI) was observed in 47 patients (43%) with a mortality of 19%. Severe leukopenia, prior steroid therapy and presence of co-infections were significant risk factors for development of PIV-LRTI in multivariate analysis. Prolonged viral shedding was frequently observed with a median duration of 14 days and up to 79 days, especially in patients after allogeneic SCT and with LRTI. Nosocomial transmission occurred in 47 patients. Phylogenetic analysis of isolated PIV strains and combination with clinical data enabled the identification of seven separate clusters of nosocomial transmission. In conclusion, we observed significant morbidity and mortality of PIV infection in hematology and transplant patients. The clinical impact of co-infections, the possibility of long-term viral shedding and frequent nosocomial transmission should be taken into account when designing infection control strategies.


Subject(s)
Coinfection , Cross Infection , Hematologic Neoplasms , Hematopoietic Stem Cell Transplantation , Paramyxoviridae Infections , Respiratory Tract Infections , Hematopoietic Stem Cell Transplantation/adverse effects , Humans , Parainfluenza Virus 3, Human/genetics , Phylogeny , Respiratory Tract Infections/epidemiology , Stem Cell Transplantation/adverse effects , Virus Shedding
8.
Support Care Cancer ; 30(9): 7469-7479, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-1877840

ABSTRACT

Autologous stem cell transplantation (ASCT) is standard of care in biologically fit, newly diagnosed multiple myeloma (MM) patients, offering better therapeutic outcomes and improved quality of life (QoL). However, with the UK's 1st national lockdown on 23/03/2020, several guidelines recommended deferring ASCT due to risks of infection, with resource limitations forcing some units to suspend ASCT entirely. Such changes to patients' treatment plans inevitably altered their lived experience during these uncertain times with expected impact on QoL. We conducted a qualitative study using semi-structured interviews to gain insight into MM patients' understanding of their disease, initial therapy and ASCT, and their response to therapy changes. A clinical snapshot of how COVID-19 affected the MM ASCT service in a single UK institution is also provided, including changes to chemotherapy treatment plans, timing, and prioritisation of ASCT. Framework analysis identified 6 overarching themes: (1) beliefs about ASCT, (2) perceptions of information provided about MM and ASCT, (3) high levels of fear and anxiety due to COVID-19, (4) feelings about ASCT disruption or delay due to COVID-19, (5) perceptions of care, and (6) importance of social support. Example subthemes were beliefs that ASCT would provide a long-remission/best chance of normality including freedom from chemotherapy and associated side-effects, disappointment, and devastation at COVID-related treatment delays (despite high anxiety about infection) and exceptionally high levels of trust in the transplant team. Such insights will help us adjust our service and counselling approaches to be more in tune with patients' priorities and expectations.


Subject(s)
COVID-19 , Hematopoietic Stem Cell Transplantation , Multiple Myeloma , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Communicable Disease Control , Humans , Multiple Myeloma/drug therapy , Quality of Life , Retrospective Studies , Stem Cell Transplantation , Transplantation, Autologous
9.
Dermatol Ther ; 35(7): e15545, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1819890

ABSTRACT

The clinical presentation of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2 COVID-19) varies from asymptomatic infection to a life-threatening, multiorgan disease. One of these manifestations is telogen effluvium (TE) which is characterized by diffuse hair loss occurring in patients previously infected with SARS-CoV-2 and lasts ~3 months, after which excessive hair loss follows. Hair follicles are known to contain a well-characterized niche for adult stem cells which is the bulge containing epithelial and melanocytic stem cells. Stem cells in the hair bulge, a demarcated structure within the lower permanent portion of hair follicles, can generate the interfollicular epidermis, hair follicle structures, and sebaceous glands. This study aims to evaluate autologous micrografts from scalp tissues as a therapeutic modality in the management of TE caused by COVID-19. Twenty patients of previous COVID-19 infection suffered from TE were included in this study for human follicle stem cells micrograft scalp treatment and they were evaluated after 3 months of treatment and after 6 months. There was significant improvement of the hair thickness and density compared with the start of the treatment and 6 months of follow-up. Autologous micrograft of the scalp showed marked improvement in the treatment of COVID-19 TE.


Subject(s)
Alopecia Areata , Autografts , COVID-19 , Hair Follicle , Microsurgery , Scalp , Adult , Alopecia Areata/etiology , Alopecia Areata/surgery , Alopecia Areata/virology , COVID-19/complications , COVID-19/virology , Follow-Up Studies , Hair Follicle/transplantation , Humans , SARS-CoV-2 , Scalp/transplantation , Stem Cell Transplantation , Time Factors
10.
JAMA Oncol ; 8(7): 1053-1058, 2022 07 01.
Article in English | MEDLINE | ID: covidwho-1801997

ABSTRACT

Importance: The durability of the antibody response to COVID-19 vaccines in patients with cancer undergoing treatment or who received a stem cell transplant is unknown and may be associated with infection outcomes. Objective: To evaluate anti-SARS-CoV-2 spike protein receptor binding domain (anti-RBD) and neutralizing antibody (nAb) responses to COVID-19 vaccines longitudinally over 6 months in patients with cancer undergoing treatment or who received a stem cell transplant (SCT). Design, Setting, and Participants: In this prospective, observational, longitudinal cross-sectional study of 453 patients with cancer undergoing treatment or who received an SCT at the University of Kansas Cancer Center in Kansas City, blood samples were obtained before 433 patients received a messenger RNA (mRNA) vaccine (BNT162b2 or mRNA-1273), after the first dose of the mRNA vaccine, and 1 month, 3 months, and 6 months after the second dose. Blood samples were also obtained 2, 4, and 7 months after 17 patients received the JNJ-78436735 vaccine. For patients receiving a third dose of an mRNA vaccine, blood samples were obtained 30 days after the third dose. Interventions: Blood samples and BNT162b2, mRNA-1273, or JNJ-78436735 vaccines. Main Outcomes and Measures: Geometric mean titers (GMTs) of the anti-RBD; the ratio of GMTs for analysis of demographic, disease, and treatment variables; the percentage of neutralization of anti-RBD antibodies; and the correlation between anti-RBD and nAb responses to the COVID-19 vaccines. Results: This study enrolled 453 patients (mean [SD] age, 60.4 [13,1] years; 253 [56%] were female). Of 450 patients, 273 (61%) received the BNT162b2 vaccine (Pfizer), 160 (36%) received the mRNA-1273 vaccine (Moderna), and 17 (4%) received the JNJ-7846735 vaccine (Johnson & Johnson). The GMTs of the anti-RBD for all patients were 1.70 (95% CI, 1.04-2.85) before vaccination, 18.65 (95% CI, 10.19-34.11) after the first dose, 470.38 (95% CI, 322.07-686.99) at 1 month after the second dose, 425.80 (95% CI, 322.24-562.64) at 3 months after the second dose, 447.23 (95% CI, 258.53-773.66) at 6 months after the second dose, and 9224.85 (95% CI, 2423.92-35107.55) after the third dose. The rate of threshold neutralization (≥30%) was observed in 203 of 252 patients (80%) 1 month after the second dose and in 135 of 166 patients (81%) 3 months after the second dose. Anti-RBD and nAb were highly correlated (Spearman correlation coefficient, 0.93 [0.92-0.94]; P < .001). Three months after the second dose, anti-RBD titers were lower in male vs female patients (ratio of GMTs, 0.52 [95% CI, 0.34-0.81]), patients older than 65 years vs patients 50 years or younger (ratio of GMTs, 0.38 [95% CI, 0.25-0.57]), and patients with hematologic malignant tumors vs solid tumors (ratio of GMTs, 0.40 [95% CI, 0.20-0.81]). Conclusions and Relevance: In this cross-sectional study, after 2 doses of an mRNA vaccine, anti-RBD titers peaked at 1 month and remained stable over the next 6 months. Patients older than 65 years of age, male patients, and patients with a hematologic malignant tumor had low antibody titers. Compared with the primary vaccine course, a 20-fold increase in titers from a third dose suggests a brisk B-cell anamnestic response in patients with cancer.


Subject(s)
COVID-19 , Neoplasms , 2019-nCoV Vaccine mRNA-1273 , Ad26COVS1 , Antibodies, Neutralizing , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Neoplasms/therapy , Prospective Studies , Stem Cell Transplantation , Vaccines, Synthetic , mRNA Vaccines
11.
Cornea ; 41(5): 651-653, 2022 May 01.
Article in English | MEDLINE | ID: covidwho-1778963

ABSTRACT

PURPOSE: The purpose of this study was to report a case of "smoldering" keratolimbal allograft (KLAL) rejection in a patient with subtherapeutic levels of systemic immunosuppression in temporal association with BNT162b2 messenger RNA vaccination for severe acute respiratory syndrome coronavirus 2. METHODS: This was a case report. OBSERVATIONS: A 72-year-old man presented with circumferential perilimbal engorgement, stagnation, and tortuosity of vessels with mild chemosis in his right eye KLAL segments 1 month after receiving the BNT162b2 messenger RNA vaccine while his tacrolimus trough blood levels were subtherapeutic measuring <2 ng/mL. He had undergone KLAL 6.5 years before for total limbal stem cell deficiency from a chemical injury and had been stable without any history of rejection. The donor was blood type O, and the patient had no systemic comorbidities. The patient was treated with hourly difluprednate 0.05% and increasing of his oral tacrolimus dose to 2 mg twice a day with improvement of rejection signs. CONCLUSIONS: There may be a temporal association between KLAL rejection after immunization against severe acute respiratory syndrome coronavirus 2 in patients with subtherapeutic levels of systemic immunosuppression. Patients should be on alert for any ocular signs or symptoms postimmunization and present for treatment immediately.


Subject(s)
COVID-19 , Corneal Diseases , Limbus Corneae , Aged , Allografts , Corneal Diseases/diagnosis , Corneal Diseases/etiology , Graft Rejection/etiology , Humans , Male , Stem Cell Transplantation/adverse effects , Vaccines, Synthetic
12.
Stem Cell Reports ; 17(4): 711-714, 2022 04 12.
Article in English | MEDLINE | ID: covidwho-1756288

ABSTRACT

The manipulation of human leukocyte antigens (HLAs) and immune modulatory factors in "universal" human pluripotent stem cells (PSCs) holds promise for immunological tolerance without HLA matching. This paradigm raises concerns should "universal" grafts become virally infected. Furthermore, immunological manipulation might functionally impair certain progeny, such as hematopoietic stem cells. We discuss the risks and benefits of hypoimmunogenic PSCs, and the need to further advance HLA matching and autologous strategies.


Subject(s)
Pandemics , Pluripotent Stem Cells , HLA Antigens , Humans , Stem Cell Transplantation/adverse effects
13.
Ophthalmol Retina ; 6(3): 254-255, 2022 03.
Article in English | MEDLINE | ID: covidwho-1747654

ABSTRACT

This prospective survey study demonstrates a lack of retina clinic patient knowledge about appropriate stem cell therapy applications for retinal disease.


Subject(s)
Retinal Diseases , Stem Cell Transplantation , Humans , Prospective Studies , Retina , Retinal Diseases/therapy
15.
Ann N Y Acad Sci ; 1507(1): 70-83, 2022 01.
Article in English | MEDLINE | ID: covidwho-1673249

ABSTRACT

For many years, it was believed that the aging process was inevitable and that age-related diseases could not be prevented or reversed. The geroscience hypothesis, however, posits that aging is, in fact, malleable and, by targeting the hallmarks of biological aging, it is indeed possible to alleviate age-related diseases and dysfunction and extend longevity. This field of geroscience thus aims to prevent the development of multiple disorders with age, thereby extending healthspan, with the reduction of morbidity toward the end of life. Experts in the field have made remarkable advancements in understanding the mechanisms underlying biological aging and identified ways to target aging pathways using both novel agents and repurposed therapies. While geroscience researchers currently face significant barriers in bringing therapies through clinical development, proof-of-concept studies, as well as early-stage clinical trials, are underway to assess the feasibility of drug evaluation and lay a regulatory foundation for future FDA approvals in the future.


Subject(s)
Aging/genetics , Aging/metabolism , Congresses as Topic/trends , Longevity/physiology , Research Report , Autophagy/physiology , COVID-19/genetics , COVID-19/metabolism , COVID-19/mortality , Cardiovascular Diseases/genetics , Cardiovascular Diseases/metabolism , Cardiovascular Diseases/therapy , Humans , Metabolomics/methods , Metabolomics/trends , Nervous System Diseases/genetics , Nervous System Diseases/metabolism , Nervous System Diseases/therapy , Stem Cell Transplantation/methods , Stem Cell Transplantation/trends
17.
Regen Med ; 17(2): 81-90, 2022 02.
Article in English | MEDLINE | ID: covidwho-1581477

ABSTRACT

Aim: To attend stem cell (SC) seminars hosted by US-based direct-to-consumer SC businesses either in person or via online 'webinars' to determine accuracy and regulatory oversight of the advertised SC therapies. Methods: The therapeutic claims, costs, risks, scientific evidence in support of a therapy and any regulatory oversight were collated using pre-established checklists. Participation consisted of one live attendance of a seminar, and following COVID-19 restrictions, review of seven recorded presentations available on the internet from SC businesses. Results & conclusion: None of the SC therapies advertised by direct-to-consumer clinics reviewed were supported by proper clinical evidence nor substantiated by peer reviewed literature.


Subject(s)
COVID-19 , Advertising , Humans , Internet , SARS-CoV-2 , Stem Cell Transplantation
18.
Cells ; 10(11)2021 11 11.
Article in English | MEDLINE | ID: covidwho-1533815

ABSTRACT

Cardiovascular disease (CVD) is one of the contributing factors to more than one-third of human mortality and the leading cause of death worldwide. The death of cardiac myocyte is a fundamental pathological process in cardiac pathologies caused by various heart diseases, including myocardial infarction. Thus, strategies for replacing fibrotic tissue in the infarcted region with functional myocardium have long been a goal of cardiovascular research. This review begins by briefly discussing a variety of somatic stem- and progenitor-cell populations that were frequently studied in early investigations of regenerative myocardial therapy and then focuses primarily on pluripotent stem cells (PSCs), especially induced-pluripotent stem cells (iPSCs), which have emerged as perhaps the most promising source of cardiomyocytes for both therapeutic applications and drug testing. We also describe attempts to generate cardiomyocytes directly from cardiac fibroblasts (i.e., transdifferentiation), which, if successful, may enable the pool of endogenous cardiac fibroblasts to be used as an in-situ source of cardiomyocytes for myocardial repair.


Subject(s)
Heart Failure/therapy , Myocardium/pathology , Regeneration/physiology , Stem Cell Transplantation , Animals , Clinical Trials as Topic , Humans , Induced Pluripotent Stem Cells/cytology
19.
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
20.
Stem Cell Reports ; 16(11): 2567-2576, 2021 11 09.
Article in English | MEDLINE | ID: covidwho-1525954

ABSTRACT

The significant morbidity and mortality of coronavirus disease 19 (COVID-19) prompted a global race to develop new therapies. These include interventions using cell- or cell-derived products, several of which are being tested in well-designed, properly controlled clinical trials. Yet, the search for cell-based COVID-19 treatments has also been fraught with hyperbolic claims; flouting of crucial regulatory, scientific, and ethical norms; and distorted communication of research findings. In this paper, we critically examine ethical issues and public communication challenges related to the development of cell-based therapeutics for COVID-19. Drawing on the lessons learned from this ongoing process, we argue against the rushed development of cell-based interventions. We conclude by outlining ways to improve the ethical conduct of cell-based clinical investigations and public communication of therapeutic claims.


Subject(s)
COVID-19/therapy , Communication , Pandemics/ethics , SARS-CoV-2 , Stem Cell Transplantation/ethics , Therapeutics/ethics , Humans
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