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WSCS 2015: The MSC Paradigm, Failed Industrial Clinical Trials, and Cellular Pharmaceuticals

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WSCS 2015: The MSC Paradigm, Failed Industrial Clinical Trials, and Cellular Pharmaceuticals

  • Date: Jul 22, 2016
  • Views: 1003
  • Domain: Medical
  • Category: Biology
Description: The Use Of Cryopreserved Allogeneic Mesenchymal Stromal Cells (MSCS) For Treatment Of An Array Of Immune And Tissue Injury Disorders Has Become Medical Practice In Many Jurisdictions. The Enthusiasm For Their Use Builds Upon Compelling Phase Ii Clinical Trial Data Published By European Collaborative Groups In The Past Few Years. Notwithstanding, A Large Multicenter Phase Iii Clinical Trials Conducted In The Usa Examining The Use Of Industrial Msc Products For Gvhd, Colitis And Stroke Fail To Meet Their Primary Clinical Endpoints Of Effectiveness When Compared To Placebo. It Is Worthwhile Taking Pause And Reflecting Upon The Apparent Discrepancy Between Encouraging Animal Pre-Clinical Data, The European Academic Experience And Industry-Sponsored Studies. This Presentation Will Focus On Articulating Plausible Failure Analysis Focusing On The Potential Variables Affecting Mscs, Potential Remedies And The Lessons Learned Informing The Cellular Pharmaceutical Field At Large.