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TIANJIN, China, Feb. 26, 2025 /PRNewswire/ -- The debate on MSCs, mesenchymal stromal cells versus mesenchymal stem cells, continued for more than two decades (since 2006), being the major obstacle for MSCs study and clinical application. The major issue focuses on mesenchymal stem cells could not be approved for clinical application without a thorough test for safety issue (e.g. tumor formation), but all pre-clinical studies proved the MSCs currently prepared and used are safe without the concerns relevant to stem cells, so that they are mesenchymal stromal cells, not stem cells. However, where is the approval? Continue Reading (PRNewsfoto/Tasly) A recent publication in HELIYON ends the debate. The work presented by Regenerative Medicine Research Center at West China Hospital and Tasly Stem cell Biology Laboratory, " Unveiling Distinctions Between Mesenchymal Stromal Cells and Stem Cells by Single-Cell Transcriptomic Analysis " breaks the momentum of confusion in the development of MSC therapy both fundamentally and practically. Using advanced single-cell RNA sequencing (scRNA-seq) and pseudotime trajectory analysis, the research group identified that stem cells exhibit robust self-renewal and differentiation capabilities, mesenchymal stromal cells (MSCs) lack the expression of these critical stemness genes. These genes include SOX2, NANOG, POU5F1, SFRP2, DPPA4, SALL4, ZFP42 and MYCN. On the other hand, there are five critical stromal cell functional genes, TMEM119, FBLN5, KCNK2, CLDN11 and DKK1, that are only expressed in the mesenchymal stromal cells, not in stem cells. The study identified that currently widely used MSCs from different tissues are mesenchymal stromal cells. But, these cells (MSCs) have been long misused as stem cells in many cases. Although the safety issue becomes ignored due to the nature of MSCs, the therapeutic efficacy of these cells has been a big drawback due to the confusion of their mechanism of action. The mechanism of action of stem cells is mediated by their capacity of differentiation to replace the damaged functional cells, but that of stromal cells is medicated by homing and excrete function leading to microenvironmental rejuvenation. Of course, these two different types of cells must be used differently for their differential function in the host. Therefore, this new breakthrough not only ends the debate on MSCs, but also and importantly, helps reorientating our effort towards effective application of MSCs in clinical practice. SOURCE Tasly WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Lexicon’s Zynquista (sotagliflozin) is an oral dual inhibitor of the sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). Image Credit: MacroEcon / Shutterstock. Lexicon Pharmaceuticals reaffirmed its plans to seek approval for Zynquista (sotagliflozin) as an adjunct treatment to insulin in type 1 diabetes (T1D) and chronic kidney disease (CKD) as part of its Q1 financial report. The US-based company expects to resubmit the new drug application (NDA) for Zynquista to the Food and Drug Administration (FDA), following feedback from the agency, by mid-2024. In 2019, the FDA declined to approve the therapy citing safety concerns following a split 8-8 vote from its advisory committee . The FDA advisory committee was particularly concerned about the risk of diabetic ketoacidosis, a serious complication that can become life-threatening if urgent treatment is not administered. The FDA rejection also resulted in Sanofi pulling out of the licensing agreement for Zynquista. Still, Lexicon was able to get approval in 2019 for Zynquista as an adjunctive treatment to insulin in T1D and CKD from the European Medicine Agency (EMA). However, in 2022, the authorisation was withdrawn by the holders of Zynquista’s marketing rights in Europe, Guidehouse Germany, with the company saying it did not wish to “market the product in the EU for commercial reasons”. Zynquista is an oral dual inhibitor of the sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2), which play a role in glucose uptake and reabsorption. The drug was approved by the FDA to reduce the risk of cardiovascular death and heart failure. It was also approved for use in patients with type 2 diabetes, CKD, and other underlying cardiovascular risk factors. It is marketed as Inpefa for the cardiovascular disease indication. See Also: Vertex Pharmaceuticals gets grant for treatment of alpha-1 antitrypsin deficiency with compound of formula (i) Ono Pharmaceutical gets grant for compound for treating disorders associated with TREK-1 and TREK-2 dysfunction Lexicon is also evaluating sotagliflozin as a treatment for hypertrophic cardiomyopathy, with a Phase III trial planned to start in mid-2024. The company has reported $355.6m in cash reserves as of 31 March. If Zynquista gets approved, it will face competition not only from other SGLT-2 inhibitors , including AstraZeneca ’s Farxiga (dapagliflozin), Boehringer Ingelheim’s Jardiance (empagliflozin) and Johnson & Johnson ’s Invokana (canagliflozin), but also from newer innovative therapies such as islet cell transplantation . In June 2023, the FDA approved the first-ever islet cell therapy for T1D, CellTrans’ Lantidra (donislecel). Other therapies in Lexicon’s portfolio include LX9211, a non-opioid therapy for diabetic peripheral neuropathic pain; and LX9851, a treatment for obesity and weight management. The company is evaluating LX9211 in a Phase II PROGRESS trial (NCT06203002), with the topline data expected in Q2 2025.