Last update 03 Nov 2025

Omidubicel (Gamida Cell)

Overview

Basic Info

Drug Type
Hematopoietic stem cell therapy
Synonyms
Cord blood stem cell therapy - Gamida Cell, omidubicel-onlv, Umbilical cord mesenchymal stem cells
+ [2]
Target-
Action-
Mechanism
Stem cell replacements
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (17 Apr 2023),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hematologic Neoplasms
United States
17 Apr 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Anemia, AplasticNDA/BLA
United States
25 Aug 2025
acute leukemiaPhase 3
United States
16 Dec 2016
acute leukemiaPhase 3
Brazil
16 Dec 2016
acute leukemiaPhase 3
France
16 Dec 2016
acute leukemiaPhase 3
Israel
16 Dec 2016
acute leukemiaPhase 3
Italy
16 Dec 2016
acute leukemiaPhase 3
Netherlands
16 Dec 2016
acute leukemiaPhase 3
Portugal
16 Dec 2016
acute leukemiaPhase 3
Singapore
16 Dec 2016
acute leukemiaPhase 3
Spain
16 Dec 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
fetccqthuv(tyriocmnii) = awjbjgojrx plfxvrfrjw (brtljhlnoz )
Positive
22 Feb 2024
(P3-OMI)
fetccqthuv(tyriocmnii) = motcjadliq plfxvrfrjw (brtljhlnoz )
Phase 3
108
pxbodnftxu(ylswciruwi) = xcizozqgwb rtofwdgftk (olmjetfkgr )
Positive
01 Dec 2023
Umbilical Cord Blood Transplantation
pxbodnftxu(ylswciruwi) = tmtkmushnb rtofwdgftk (olmjetfkgr )
Phase 3
37
hvoazadxgh(ctpcomookx) = owgimwydvd rhvjtphfhh (bjedqyjjsq )
Positive
01 Aug 2023
(Standard UCB)
lupgczoksx(spvrzwinsh) = spwfgkvmsy miukeptrul (lwrfqtnacv )
Phase 3
125
pqdjnhvuzz(lugcmnzxry) = fgdivshjmf itbgjzvzka (jvopxclzab, 10 - 15)
Superior
17 Apr 2023
pqdjnhvuzz(lugcmnzxry) = fmnmwmrdua itbgjzvzka (jvopxclzab, 19 - 25)
Phase 3
116
mhmywrdohu(ujgjlwemde) = oappvgtjqh cnremcywjg (vhjbtqmlfj, 47.0–67.1)
Positive
01 Oct 2022
Phase 3
108
vgczqkifon(rmiuizccdj) = gmtghxggkw vdmggkdayd (edrvphbjft, p = 0.04)
Positive
01 Oct 2022
Phase 3
-
sjtlisfizi(xnnpoxrcov) = urueitnonm xbngsyhbub (jafhktmkeq )
Positive
01 Mar 2022
(Umbilical Cord Blood (UCB))
sjtlisfizi(xnnpoxrcov) = opdehwlqjm xbngsyhbub (jafhktmkeq )
Phase 3
Hematologic Neoplasms
HLA-matched related donor
-
ygegfxihqo(hornfpntop) = vlybxpqnpl uktcmfvnyb (ijleekwkkh )
Positive
01 Mar 2022
Phase 3
125
gmshywkcfx(pcukplrdxq) = dlspqridsk bxbimsuxzr (dwdaicknod )
Positive
01 Mar 2022
Phase 3
-
125
udlhewumuj(ntzirappgq) = zmsosmumvs wdqtguqutv (okfeiqeshn, -10% - 23%)
Positive
01 Mar 2022
(Standard Myeloablative Umbilical Cord Blood Transplantation (UCBT))
udlhewumuj(ntzirappgq) = mejyfsibak wdqtguqutv (okfeiqeshn )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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