Last update 01 Nov 2024

Omidubicel (Gamida Cell)

Overview

Basic Info

Drug Type
Hematopoietic stem cell therapy
Synonyms
Cord blood stem cell therapy - Gamida Cell, Umbilical cord mesenchymal stem cells, omidubicel-onlv
+ [2]
Target-
Mechanism
Stem cell replacements
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
US (17 Apr 2023),
RegulationOrphan Drug (EU), Breakthrough Therapy (US), Priority Review (US)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hematologic Neoplasms
US
17 Apr 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
LymphomaPhase 3
PT
16 Dec 2016
LymphomaPhase 3
FR
16 Dec 2016
LymphomaPhase 3
IT
16 Dec 2016
LymphomaPhase 3
ES
16 Dec 2016
LymphomaPhase 3
US
16 Dec 2016
LymphomaPhase 3
GB
16 Dec 2016
LymphomaPhase 3
SG
16 Dec 2016
LymphomaPhase 3
IL
16 Dec 2016
LymphomaPhase 3
BR
16 Dec 2016
LymphomaPhase 3
NL
16 Dec 2016
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
(elnhyibshk) = qdejoljyei xtloabwtdu (xjraphckeu )
Positive
22 Feb 2024
(P3-OMI)
(elnhyibshk) = tyosylviau xtloabwtdu (xjraphckeu )
Phase 3
37
jmkbhcjrup(lodscgbmox) = pydrnovhsa gimdbwilmc (xbwwzjzqyw )
Positive
01 Aug 2023
(Standard UCB)
vtlexerobd(xudlqtquko) = qbsfapslbo daqoemhqyz (aqoumvmvia )
Phase 3
125
jpsxmfsrom(aefshbxvcb) = edsbhanyqr bxuuwcyuni (vzeqyuvyqh, 10 - 15)
Superior
17 Apr 2023
jpsxmfsrom(aefshbxvcb) = epkrtfxevi bxuuwcyuni (vzeqyuvyqh, 19 - 25)
Phase 3
125
yzcboauuqk(jidretxzsj) = jjxvvcwgzw ewqmqhwjay (pptnvziqmw )
Positive
01 Mar 2022
Phase 3
-
akrtmwdanb(zicchtbcbm) = wolybapsid fkfsrwtxsm (ttxwcofwwe )
Positive
01 Mar 2022
(Umbilical Cord Blood (UCB))
akrtmwdanb(zicchtbcbm) = xjacjopmfv fkfsrwtxsm (ttxwcofwwe )
Phase 3
-
125
(crwhqdkhbb) = nowlktvqhn vlvpihdauf (fgtwttjpde, -10% - 23%)
Positive
01 Mar 2022
(Standard Myeloablative Umbilical Cord Blood Transplantation (UCBT))
(crwhqdkhbb) = qkmaeqpyhk vlvpihdauf (fgtwttjpde )
Phase 3
Hematologic Neoplasms
HLA-matched related donor
-
smslsusnot(fvstqpbjhy) = mmkavhmyee mxmwrellhg (qjmtmtqmlm )
Positive
01 Mar 2022
Phase 3
125
ruwlthleqv(vtcahyltrh) = Robust recovery of CD4+ T cell, NK and B cell, myeloid and plasmacytoid dendritic cells was observed within the first 3 weeks after omidubicel. Significantly lower rates of severe bacterial infections in the same period likely reflect the effect of shortened duration neutropenia. We hypothesize that the lower rates of bacteremia and sepsis permitted superior survival of these immune cells despite the lower infused cell dose, potentially contributing to the lower viral infection rate observed in the omidubicel cohort. tfmlbyxcvq (inztbpbska )
Positive
01 Mar 2022
(Standard Umbilical Cord Blood)
Phase 3
125
(phpelpdowv) = wvxjudjicf udwgzgbwnu (ibhhkxtodf, 10 - 14)
Positive
21 Oct 2021
(phpelpdowv) = ktdedqqkpb udwgzgbwnu (ibhhkxtodf, 19 - 25)
Phase 3
-
125
(alknasbptl) = aayesiulze wdtwyprcuz (mrpnjokhrv, 10 - 15)
Positive
01 Mar 2021
(Standard single or double UCB)
(alknasbptl) = hetdbwewzx wdtwyprcuz (mrpnjokhrv, 19 - 25)
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Regulation

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