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MC 0518

Drug Profile

MC 0518

Alternative Names: Human allogeneic bone marrow derived mesenchymal stromal cells - Medac; MC0518; Mesenchymal stromal cells - Medac; MSC-FFM - Medac; Obnitix

Latest Information Update: 16 Feb 2024

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At a glance

  • Originator Medac
  • Class Mesenchymal stem cell therapies
  • Mechanism of Action Cell replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Graft-versus-host disease
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Graft-versus-host disease

Most Recent Events

  • 13 Nov 2023 Phase-II clinical trials in Graft-versus-host disease (In neonates, In infants, In children, In adolescents, Treatment-experienced) in Spain, Germany (IV) (NCT06075706) (EudraCT2023-503952-28-00)
  • 10 Oct 2023 Medac plans a phase II trial for Graft-versus-host disease (In neonates, In infants, In children, In adolescents, Treatment-experienced) (IV, Infusion) in October 2023 (NCT06075706), (EudraCT2023-503952-28-00)
  • 13 Oct 2022 MC 0518 is still in phase III trials for Graft-versus-host disease in France, Germany and Poland (EudraCT2019-001462-15, NCT04629833)
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