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A Randomised, Open label, Multicentre, Phase 3 Trial of First line Treatment with Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects with Steroid refractory Acute Graft versus host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)

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Trial Profile

A Randomised, Open label, Multicentre, Phase 3 Trial of First line Treatment with Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects with Steroid refractory Acute Graft versus host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 May 2024

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At a glance

  • Drugs MC 0518 (Primary) ; Antithymocyte globulin; Everolimus; Mycophenolate mofetil; Ruxolitinib
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Acronyms IDUNN
  • Sponsors Medac
  • Most Recent Events

    • 27 May 2024 Planned End Date changed from 31 Dec 2027 to 1 Dec 2027.
    • 27 May 2024 Planned primary completion date changed from 28 Jan 2024 to 1 Dec 2025.
    • 02 Nov 2023 Planned End Date changed from 31 Dec 2025 to 31 Dec 2027.
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