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    DRUG:

    Omisirge (omidubicel)

    i
    Other names: UCB-derived ex vivo nicotinamide-expanded hematopoietic stem and progenitor cells, umbilical cord blood-derived ex vivo nicotinamide-expanded hematopoietic stem and progenitor cells
    Associations

    News

    Trials
    Company:
    Ayrmid
    Drug class:
    Immunostimulant, Stem cell stimulant
    Related drugs:
    Associations

    News

    Trials
    20d
    HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT (clinicaltrials.gov)
    P1, N=10, Recruiting, Duke University | Initiation date: Sep 2025 --> Dec 2025
    Trial initiation date
    |
    Omisirge (omidubicel)
    3ms
    HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT (clinicaltrials.gov)
    P1, N=10, Recruiting, Duke University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Omisirge (omidubicel)
    5ms
    Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies (clinicaltrials.gov)
    P3, N=36, Completed, Gamida Cell ltd | Active, not recruiting --> Completed
    Trial completion
    |
    Omisirge (omidubicel)
    7ms
    Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome (clinicaltrials.gov)
    P1/2, N=37, Recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Mar 2028 --> Mar 2032
    Trial completion date
    |
    CD34 (CD34 molecule) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
    |
    Omisirge (omidubicel)
    7ms
    Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome (clinicaltrials.gov)
    P1/2, N=37, Recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial primary completion date: Apr 2026 --> Apr 2027
    Trial primary completion date
    |
    CD34 (CD34 molecule) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
    |
    Omisirge (omidubicel)
    7ms
    Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome (clinicaltrials.gov)
    P1/2, N=37, Recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial primary completion date: Apr 2025 --> Apr 2026
    Trial primary completion date
    |
    CD34 (CD34 molecule) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
    |
    Omisirge (omidubicel)
    8ms
    Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS (clinicaltrials.gov)
    P3, N=125, Completed, Gamida Cell ltd | Active, not recruiting --> Completed
    Trial completion
    |
    Omisirge (omidubicel)
    12ms
    HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT (clinicaltrials.gov)
    P1, N=10, Not yet recruiting, Duke University
    New P1 trial
    |
    Omisirge (omidubicel)
    over1year
    Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome (clinicaltrials.gov)
    P1/2, N=37, Recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial primary completion date: Apr 2024 --> Apr 2025
    Trial primary completion date
    |
    CD34 (CD34 molecule) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
    |
    Omisirge (omidubicel)
    2years
    Omidubicel-Onlv for Allogeneic Transplantation (allo-HCT) in Patients with Hematologic Malignancies: Results of a Multicenter Open Label Expanded Access Program (ASH 2023)
    ConclusionIn a real-world EAP setting, the outcomes of allo-HCT with omidubicel in patients with hematologic malignancies were consistent with those from the phase 3 registration study. These data support the role of omidubicel as a donor source, particularly for patients from diverse racial Background s.
    Clinical
    |
    Omisirge (omidubicel)
    2years
    A new beginning: can omidubicel emerge as the next, viable alternative donor source? (PubMed, Ther Adv Hematol)
    Omidubicel has now been granted U.S. Food & Drug Administration approval to enhance neutrophil recovery and decrease infectious risk. This review will focus on CBT, benefits and barriers to using this alternative donor source, and finally the potential advancements with incorporation of omidubicel in the transplant setting for malignant and non-malignant diseases.
    Review • Journal
    |
    Omisirge (omidubicel)
    over2years
    Omidubicel: First Approval. (PubMed, Mol Diagn Ther)
    In April 2023, omidubicel received its first approval in the USA for use in adults and children aged ≥ 12 years with haematological malignancies who are planned for cord blood transplantation following myeloablative conditioning to reduce the incidence of infection and the time to neutrophil recovery. This article summarizes the milestones in the development of omidubicel leading to this first approval.
    Review • Journal
    |
    Omisirge (omidubicel)