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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.

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Background: Metabolic and bariatric surgery (MBS) is a suitable solution for the treatment of morbid obesity. Investigating an MBS method that has the best outcomes has always been the main concern of physicians. The current study aimed to compare nutritional, anthropometric, and psychological complications of individuals undergoing various MBS Techniques.

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Metabolic profiles of meconium in preeclamptic and normotensive pregnancies.

Metabolomics

January 2025

Center for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.

Introduction: Preeclampsia (PE) is a common vascular pregnancy disorder affecting maternal and fetal metabolism with severe immediate and long-term consequences in mothers and infants. During pregnancy, metabolites in the maternal circulation pass through the placenta to the fetus. Meconium, a first stool of the neonate, offers a view to maternal and fetoplacental unit metabolism and could add to knowledge on the effects of PE on the fetus and newborn.

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Background: The long-term effects of breakfast on childhood z-BMI remain inconclusive.

Objective: To prospectively assess the impact of stable and altered breakfast consumption habits on z-BMI change over two years, in school-aged children across six European countries.

Methods: Data of 6,528 children (8.

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