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Total 29 results found since Jan 2013.
Regulation of advanced therapies in Europe: Are we on the right track?
Cell Stem Cell. 2023 Aug 3;30(8):1013-1016. doi: 10.1016/j.stem.2023.07.004.ABSTRACTSixteen years after regulating advanced therapy medicinal products (ATMPs) in the European Union, few ATMPs have gained marketing authorization. Additionally, market withdrawals for commercial reasons and a lack of reimbursement are de facto blocking patient access. Here, we pinpoint the major factors underlying this roadblock and how to circumvent it.PMID:37541207 | DOI:10.1016/j.stem.2023.07.004
Source: Cell Stem Cell - August 4, 2023 Category: Stem Cells Authors: Ander Izeta Natividad Cuende Source Type: research
Treating high-risk myelodysplastic syndromes
Bull Cancer. 2023 Jul 3:S0007-4551(23)00285-0. doi: 10.1016/j.bulcan.2023.02.029. Online ahead of print.ABSTRACTMyelodysplastic syndromes (MDS) are clonal stem cell diseases that primarily affect the elderly. They are classified into low- and high-risk MDS according to prognostic scoring systems. In high-risk patients, treatment should aim to modify the course of the disease by preventing progression to acute myeloid leukemia, and thus improve survival. Stem cell transplantation remains the only curative treatment when possible, but this concerns a small minority of patients. Treatment is mainly based on hypomethylating ag...
Source: Bulletin du Cancer - July 5, 2023 Category: Cancer & Oncology Authors: Lionel Ad ès Source Type: research
Testing the nonclinical Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm with an established anti-seizure medication: Levetiracetam case study
Pharmacol Res Perspect. 2023 Feb;11(1):e01059. doi: 10.1002/prp2.1059.ABSTRACTLevetiracetam (LEV), a well-established anti-seizure medication (ASM), was launched before the original ICH S7B nonclinical guidance assessing QT prolongation potential and the introduction of the Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm. No information was available on its effects on cardiac channels. The goal of this work was to "pressure test" the CiPA approach with LEV and check the concordance of nonclinical core and follow-up S7B assays with clinical and post-marketing data. The following experiments were conducted with LE...
Source: Cell Research - February 7, 2023 Category: Cytology Authors: Annie Delaunois Fran çois-Xavier Mathy Miranda Cornet Vitalina Gryshkova Chlo é Korlowski Fran çois Bonfitto Juliane Koch Anne-Fran çoise Schlit Simon Hebeisen Elisa Passini Blanca Rodriguez Jean-Pierre Valentin Source Type: research
Challenges in Mesenchymal Stromal Cell-based Therapies
Curr Stem Cell Res Ther. 2022 Aug 31. doi: 10.2174/1574888X17666220831104747. Online ahead of print.ABSTRACTOver 50 years have passed since discovering mesenchymal stromal cells (MSCs). Initially, despite gaps in the knowledge of the identity of these cells, their therapeutic aspects were recognized. Consequently, MSCs became candidates for treating a wide range of diseases. However, the therapeutic effects of MSCs are not stable in the long term, and there are inconsistent data on their clinical efficacy. Even though more than 1000 MSC-based clinical trials have been registered, and the safety of MSC-based cell therapies ...
Source: Current Stem Cell Research and Therapy - September 1, 2022 Category: Stem Cells Authors: Maria Kavianpour Naser Ahmadbeigi Source Type: research
