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Omidubicel onlv- Gamida Cell

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Drug Profile

Omidubicel onlv- Gamida Cell

Alternative Names: Cord blood stem cell therapy - Gamida Cell; CordIn; NiCord; Omidubicel; Omidubicel-onlv; Omisirge; UC MSC; Umbilical cord blood stem cell therapy - Gamida Cell

Latest Information Update: 12 Dec 2025

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At a glance

  • Originator Gamida-Cell
  • Class Antineoplastics; Immunotherapies; Mesenchymal stem cell therapies; 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 - Hodgkin's disease; Haematological malignancies; Acute myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma; Myelodysplastic syndromes
  • New Molecular Entity No

Highest Development Phases

  • Marketed Aplastic anaemia; Haematological malignancies
  • Phase I/II Haemoglobinopathies; Myelodysplastic syndromes; Sickle cell anaemia; Thalassaemia

Most Recent Events

  • 12 Dec 2025 Launched for Aplastic anaemia (In adolescents, In adults, In children) in USA (IV)
  • 08 Dec 2025 Registered for Aplastic anaemia (In adults, In adolescents, In children) in USA (IV)
  • 29 Oct 2025 Efficacy and adverse event data from a phase I/II trial in Aplastic anaemia released by Gamida Cell

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