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ISCT MSC committee statement on the US FDA approval of allogenic bone-marrow mesenchymal stromal cells.
Cytotherapy
January 2025
Osteoarthritis Research Program, Division of Orthopedic Surgery, Schroeder Arthritis Institute, University Health Network, Toronto, Ontario, Canada; Krembil Research Institute, University Health Network, Toronto, Ontario, Canada; Institute of Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada; Department of Medicine, Division of Hematology, University of Toronto, Toronto, Ontario, Canada. Electronic address:
The December 2024 US Food and Drug Administration (FDA) approval of Mesoblast's Ryoncil (remestemcel-L-rknd)-allogeneic bone marrow mesenchymal stromal cell (MSC(M)) therapy-in pediatric acute steroid-refractory graft-versus-host-disease finally ended a long-lasting drought on approved MSC clinical products in the United States. While other jurisdictions-including Europe, Japan, India, and South Korea-have marketed autologous or allogeneic MSC products, the United States has lagged in its approval. The sponsor's significant efforts and investments, working closely with the FDA addressing concerns regarding clinical efficacy and consistent MSC potency through an iterative process that spanned several years, was rewarded with this landmark approval.
View Article and Find Full Text PDFAntimicrobial consumption and resistance in a tertiary care hospital in Brazil: a 7-year time series.
J Infect Dev Ctries
December 2024
Faculdade de Farmácia, Universidade Federal de Minas Gerais, Brazil.
Introduction: Antimicrobial resistance (AMR) is a major public health challenge globally. This study aimed to analyze the antibacterial consumption (ATBc), and the incidence of multidrug-resistant organisms (MDRO), focusing on pathogens Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp. (ESKAPE group), in a Brazilian tertiary care hospital.
View Article and Find Full Text PDFRole of ivermectin and colchicine in the treatment of COVID-19: a randomized controlled clinical trial.
J Infect Dev Ctries
December 2024
Internal Medicine Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Introduction: The objective of this study was to assess the effectiveness of ivermectin and colchicine as treatment options for coronavirus disease 2019 (COVID-19).
Methodology: A three-arm randomized controlled clinical trial was conducted in the Triage Clinic of the family medicine department at Ain Shams University Hospitals on participants who had been diagnosed with moderate COVID-19. Patients aged < 18 years or > 65 years, with any co-morbidities, pregnant or lactating females, and those with mild or severe COVID-19 confirmed cases were excluded.
Metabolic adaptations to acute glucose uptake inhibition converge upon mitochondrial respiration for leukemia cell survival.
Cell Commun Signal
January 2025
Department of Oncological Sciences, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY, 10029, USA.
One hallmark of cancer is the upregulation and dependency on glucose metabolism to fuel macromolecule biosynthesis and rapid proliferation. Despite significant pre-clinical effort to exploit this pathway, additional mechanistic insights are necessary to prioritize the diversity of metabolic adaptations upon acute loss of glucose metabolism. Here, we investigated a potent small molecule inhibitor to Class I glucose transporters, KL-11743, using glycolytic leukemia cell lines and patient-based model systems.
View Article and Find Full Text PDFEfficacy and safety of SHEN26, a novel oral small molecular RdRp inhibitor for COVID-19 treatment: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial.
Virol J
January 2025
Medi-X Pingshan, Southern University of Science and Technology, Shenzhen, Guangdong, 518118, China.
Background: SHEN26 (ATV014) is an oral RNA-dependent RNA polymerase (RdRp) inhibitor with potential anti-SARS-CoV-2 activity. Safety, tolerability, and pharmacokinetic characteristics were verified in a Phase I study. This phase II study aimed to verify the efficacy and safety of SHEN26 in COVID-19 patients.
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