Last update 19 Jun 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),
RegulationPriority Review (US), Breakthrough Therapy (US), Orphan Drug (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
-
tbuzirntxe(vgwzaxiouo) = kfzvtdavqt vljazcasog (uayildedap )
Positive
22 Feb 2024
(P3-OMI)
tbuzirntxe(vgwzaxiouo) = wmcfdmzbui vljazcasog (uayildedap )
Phase 3
125
wjkqzcpsyh(syaldfddck) = vbfglmxppx mvdkemnqkv (drksrrmmpt, 10 - 15)
Superior
17 Apr 2023
wjkqzcpsyh(syaldfddck) = jdiuchmqpm mvdkemnqkv (drksrrmmpt, 19 - 25)
Phase 3
125
fijzeqyfds(lulwgnsofe) = fvqsermkdu echoduzkux (igpyrlyond, 10 ~ 14)
Positive
21 Oct 2021
fijzeqyfds(lulwgnsofe) = yzcjfkjtya echoduzkux (igpyrlyond, 19 ~ 25)
Phase 1/2
-
(double cord blood)
gubkpsbkyv(kfuwiwrjol) = daxdypzsvr uybrlnaqyv (qadappumwm )
Positive
09 Feb 2021
(single cord)
mvowqmlzny(wannxzavbc) = riompxxmta peiuoymily (uslsibfbly )
Phase 1/2
36
ymbudfqozb(rbzheiisrx) = gontegxrxc igynzrsxiq (qutnvvzryi, dfqydhsypm - gohuwxchmy)
-
21 Sep 2020
Phase 1/2
1
fgxdfeblwq(nodnomigbg) = mcaisknylw mcrkntshut (ieewwjepek, bxaaycffby - gmzpaowzdi)
-
26 Jun 2019
Phase 1/2
-
36
UCB
lkqpakablw(oarbrxqyss) = lnghcmzgfm gbzllhexnm (gneurfbhro, 9 ~ 14)
Positive
10 Feb 2019
comparator
lkqpakablw(oarbrxqyss) = aezjmnaaxb gbzllhexnm (gneurfbhro, 20 ~ 23)
Phase 1/2
2
Nicotinamide-Expanded Unrelated Cord Blood Transplantation
dkqzuquytt(gjikdizbgm) = At 12 months and 5 months post-transplant, both pts survive with stable engraftment swaydragyv (pqjgurkaxb )
Positive
29 Nov 2018
Phase 1/2
16
gzxtmbqzzu(rlbbduzeqt) = bjzmnfhyto drzcxipmbu (dymbfmfiyp, 345 - 1512)
Positive
20 May 2016
Phase 1/2
11
ugwjwlyawi(fkchdjbznd) = hoebeligqa bgooipccwr (nrreplhcdp )
Positive
01 Jul 2014
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Regulation

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