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A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS

Trial Profile

A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Feb 2025

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At a glance

  • Drugs Allogeneic mesenchymal stem cells therapy-Bonus BioGroup (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Bonus BioGroup
  • Most Recent Events

    • 20 Feb 2025 According to a Bonus BioGroup media release, company announced that it has received U.S. Food and Drug Administration (FDA) clearance to proceed with a Phase III clinical study in the United States to evaluate the efficacy and safety of MesenCure to treat respiratory distress in hospitalized, severely ill patients resulting from pneumonia related to COVID-19. The IND application is supported, among other factors, by results from a Phase II clinical study of MesenCure completed in 2022.
    • 28 Sep 2023 Planned End Date changed from 1 Jul 2024 to 1 Jul 2026.
    • 28 Sep 2023 Planned primary completion date changed from 31 Dec 2023 to 1 Jun 2026.

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