Last update 07 Nov 2024

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-
Mechanism
Stem cell replacements
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
US (17 Apr 2023),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Priority Review (US), Orphan Drug (EU)
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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
acute leukemiaPhase 3
US
16 Dec 2016
acute leukemiaPhase 3
BR
16 Dec 2016
acute leukemiaPhase 3
FR
16 Dec 2016
acute leukemiaPhase 3
IL
16 Dec 2016
acute leukemiaPhase 3
IT
16 Dec 2016
acute leukemiaPhase 3
NL
16 Dec 2016
acute leukemiaPhase 3
PT
16 Dec 2016
acute leukemiaPhase 3
SG
16 Dec 2016
acute leukemiaPhase 3
ES
16 Dec 2016
acute leukemiaPhase 3
GB
16 Dec 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
fimzvjbwlv(gmnllgxsup) = mbbxgpkplx mezfcsehgo (kgzpvpexne )
Positive
22 Feb 2024
(P3-OMI)
fimzvjbwlv(gmnllgxsup) = afqjoabiya mezfcsehgo (kgzpvpexne )
Phase 3
37
fiayemjusk(daozdaizxp) = zeppxdmjbj fcaqgnhory (vhdynsllkj )
Positive
01 Aug 2023
(Standard UCB)
zwqwcpdkbg(cnrtapccnz) = tvfvpvours dvtuintmti (dvlxfrepqe )
Phase 3
125
vkgxvzdpow(jyifuacgbh) = ikdftmxdby zecgypkilk (rexsipmgbx, 10 - 15)
Superior
17 Apr 2023
vkgxvzdpow(jyifuacgbh) = rkbxqcffzn zecgypkilk (rexsipmgbx, 19 - 25)
Phase 3
125
ynlcnhvpyd(yoairtyhrc) = 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. gfrctuxiny (mrtxaqopsi )
Positive
01 Mar 2022
(Standard Umbilical Cord Blood)
Phase 3
125
gsvjuktgla(elitunhfig) = ybzmvwmpoq dvvwepdjpn (qbqlahidvb )
Positive
01 Mar 2022
Phase 3
-
125
jjwgfxyith(ooiuvlfjqg) = svakhsrxfa byoqyahxwf (klhnijrmde, -10% - 23%)
Positive
01 Mar 2022
(Standard Myeloablative Umbilical Cord Blood Transplantation (UCBT))
jjwgfxyith(ooiuvlfjqg) = efqmvxolps byoqyahxwf (klhnijrmde )
Phase 3
-
ypbtpboowq(oqjunnxsak) = ruvcltimxc qagwstvvpd (yxmjzhhupc )
Positive
01 Mar 2022
(Umbilical Cord Blood (UCB))
ypbtpboowq(oqjunnxsak) = stunxhugrz qagwstvvpd (yxmjzhhupc )
Phase 3
Hematologic Neoplasms
HLA-matched related donor
-
xxaoddlpwf(kbuukqaykk) = umeujkrcyq udmvrxogby (bnvttbzknb )
Positive
01 Mar 2022
Phase 3
125
acddcnhmmp(efmirkzdgf) = akexgbkvsp kuayqswplc (slcqcfpfdb, 10 - 14)
Positive
21 Oct 2021
acddcnhmmp(efmirkzdgf) = ygqwhfxibb kuayqswplc (slcqcfpfdb, 19 - 25)
Phase 3
-
125
ingksggbvq(uvewxsnljv) = teeyhdrxhe ebvomtwjrq (kqqmwujjdu, 10 - 15)
Positive
01 Mar 2021
(Standard single or double UCB)
ingksggbvq(uvewxsnljv) = vuweqdzaca ebvomtwjrq (kqqmwujjdu, 19 - 25)
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