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| http://dx.doi.org/10.3389/fnins.2023.1189749 | DOI Listing |
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ISCT MSC committee statement on the US FDA approval of allogenic bone-marrow mesenchymal stromal cells.
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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 PDFNeoadjuvant treatment in advanced resectable melanoma and the need for a predictive biomarker - is pathologic complete response (pCR) the answer?
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University of Michigan, Department of Medicine, Division of Medical Oncology, Ann Arbor, MI, USA; University of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.
Natural phytochemicals reverting M2 to M1 macrophages: A novel alternative Leishmaniasis therapy.
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Immunology lab, Biotechnology & Bioengineering, Indian Institute of Advanced Research, Gandhinagar, Gujarat, 382426, India. Electronic address:
Introduction: Leishmaniasis is a tropical parasitic disease caused by the protozoan Leishmania which remains a significant global health concern with diverse clinical manifestations. Transmitted through the bite of an infected sandfly, its progression depends on the interplay between the host immune response and the parasite. The disease outcome is linked to macrophage polarisation into M1 and M2 phenotypes.
View Article and Find Full Text PDFAdvancing medication compounding: Use of a pharmaceutical 3D printer to auto-fill minoxidil capsules for dispensing to patients in a community pharmacy.
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Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, I+D Farma (GI-1645), Facultad de Farmacia, Instituto de Materiales (iMATUS) and Health Research Institute of Santiago de Compostela (IDIS), Universidade de Santiago de Compostela, 15782 Santiago de Compostela, Spain; FABRX Artificial Intelligence, Carretera de Escairón, 14, Currelos (O Saviñao) CP 27543, Spain; FABRX Ltd., Henwood House, Henwood, Ashford, Kent TN24 8DH, UK; Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK. Electronic address:
Compounding medications in pharmacies is a common practice for patients with prescriptions that are not available commercially, but it is a laborious and error-prone task. The incorporation of emerging technologies to prepare personalised medication, such as 3D printing, has been delayed in smaller pharmacies due to concerns about potential workflow disruptions and learning curves associated with novel technologies. This study examines the use in a community pharmacy of a pharmaceutical 3D printer to auto-fill capsules and blisters using semisolid extrusion, incorporating an integrated quality control system.
View Article and Find Full Text PDFTertiary Lymphoid Structures as a Biomarker in Immunotherapy and Beyond: Advancing Towards Clinical Application.
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. Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. Electronic address:
Tertiary lymphoid structures (TLSs) are ectopic immune cell clusters formed in nonlymphoid tissues affected by persistent inflammation, such as in cancer and prolonged infections. They have features of the structure and function of secondary lymphoid organs, featuring central CD20+ B cells, surrounded by CD3+ T cells, CD21+ follicular dendritic cells, and CD68+ macrophages, with a complex vascular system. TLS formation is governed by lymphotoxin-α1β2, TNF, and chemokines like CCL19, CCL21, and CXCL13, differing from secondary lymphoid organ development in developing later in life at sites of chronic inflammation.
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