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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 PDFEvaluating Clinician Experience in Health Care Transition: Results From Six Health Systems.
J Adolesc Health
January 2025
The National Alliance to Advance Adolescent Health/Got Transition, Washington, D.C.
Purpose: There is a paucity of evidence examining clinician experiences with structured health-care transition (HCT) programs. Among HCT Learning Collaborative participants, this study describes clinician experiences with implementation of a structured HCT process: Got Transition's 6 Core Elements.
Methods: Representative members from 6 health systems designed a survey to collect clinician feedback regarding HCT and demographic and practice information.
Advances in Diagnosis, Treatment and Prognostic in Aortoiliac Occlusive Disease - A Narrative Review.
Port J Card Thorac Vasc Surg
January 2025
Department of Biomedicine - Unit of Anatomy, Faculty of Medicine, University of Porto; RISE@Health, Porto, Portugal.
Background: Aortoiliac disease (AID) is a variant of peripheral artery disease involving the infrarenal aorta and iliac arteries. Similar to other arterial diseases, aortoiliac disease obstructs blood flow through narrowed lumens or by embolization of plaques. AID, when symptomatic, may present with a triad of claudication, impotence, and absence of femoral pulses, a triad also referred as Leriche Syndrome (LS).
View Article and Find Full Text PDFThe effects of unified pooling arrangement on health inequity in China: a DID-RIF approach.
BMC Health Serv Res
January 2025
School of Humanities and Social Sciences, Beihang University, No. 37 Xueyuan Road, Beijing, 100191, China.
Background: To address the health inequity caused by decentralized management, China has introduced a provincial pooling system for urban employees' basic medical insurance. This paper proposes a research framework to evaluate similar policies in different contexts. This paper adopts a mixed-methods approach to more comprehensively and precisely capture the causal effects of the policy.
View Article and Find Full Text PDFLay views in Southern France of the acceptability of refusing to provide treatment because of alleged futility.
BMC Med Ethics
January 2025
Ethics and Work Research Unit, Institute of Advanced Studies (EPHE), Paris, France.
Aim: To carry out a detailed study of existing positions in the French public of the acceptability of refusing treatment because of alleged futility, and to try to link these to people's age, gender, and religious practice.
Method: 248 lay participants living in southern France were presented with 16 brief vignettes depicting a cancer patient at the end of life who asks his doctor to administer a new cancer treatment he has heard about. Considering that this treatment is futile in the patient's case, the doctor refuses to prescribe it.
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