Omisirge (omidubicel)

P1/2, N=37, Recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial primary completion date: Apr 2024 --> Apr 2025

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.

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.

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.

P3, N=125, Active, not recruiting, Gamida Cell ltd | Trial completion date: Apr 2024 --> Feb 2025

P1/2, N=37, Recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial primary completion date: Apr 2023 --> Apr 2024

This was also observed in a control arm patient who received only unmanipulated UCB. In conclusion, omidubicel demonstrated stable trilineage hematopoiesis, immune competence, and graft durability in extended follow-up.

Our findings suggest that omidubicel efficiently promotes IR across multiple immune cells, including CD4+ T cells, B cells, NK cells, and dendritic cell subtypes as early as 7 days post-transplant, potentially endowing recipients of omidubicel with early protective immunity.

Omidubicel demonstrated durable long-term hematopoiesis and immune competence. One case of dd-MN was observed with both omidubicel and control UCB.

Omidubicel demonstrated durable long-term hematopoiesis and immune competence. One case of dd-MN was observed with both omidubicel and control UCB.

P1/2, N=37, Recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Dec 2023 --> Mar 2028 | Trial primary completion date: Apr 2022 --> Apr 2023

There was only one case of secondary graft failure in this cohort, demonstrating long-term repopulation ability. Chronic GVHD was observed, but most patients were able to wean off immunosuppression.

Chronic GVHD was observed, but most patients were able to wean off immunosuppression. In summary, omidubicel is a safe and reliable stem cell source for patients in need of hematopoietic cell transplantation, particularly for underrepresented racial and ethnic minorities.

P1/2, N=37, Recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Apr 2022 --> Dec 2023

P2, N=15, Not yet recruiting, Fred Hutchinson Cancer Research Center | Trial completion date: Aug 2021 --> Jun 2025 | Trial primary completion date: Jan 2020 --> Jun 2023

P1/2, N=37, Recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Apr 2021 --> Apr 2022 | Trial primary completion date: Apr 2021 --> Apr 2022

It was also faster than that expected after a mobilized peripheral blood stem cell transplantation. These data demonstrate that omidubicel is a highly effective graft source for patients in need of allogeneic transplantation.