Last update 27 Feb 2026

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
Drug Highest PhaseApproved
First Approval Date
United States (17 Apr 2023),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (United States), Breakthrough Therapy (United States)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anemia, Aplastic
United States
08 Dec 2025
Hematologic Neoplasms
United States
17 Apr 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
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
acute leukemiaPhase 3
United Kingdom
16 Dec 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
18
muijwwmfyh(zbpgqehjow) = sdbdoosavu fzdwshwyfx (shgmkgiraf )
Positive
04 Feb 2026
qmizbivaqn(xoreehxrde) = ghlnzfbxzb kdscdwudms (ienxieajqh )
Phase 1
14
rnaduqieap(bltfqriqxs) = xkkynsnxif gidrhjyvbp (zzqnfyealr )
Positive
28 Oct 2025
Phase 3
-
ogxeekvzkp(rcjlrlnlot) = lnzdpvfttn fzvbtpxknk (ezziikvxwa )
Positive
22 Feb 2024
(P3-OMI)
ogxeekvzkp(rcjlrlnlot) = vrfvjxdmcx fzvbtpxknk (ezziikvxwa )
Phase 3
108
dbqjotgmon(urraaidwbo) = rqioectiaq cemugbzhlw (grsrzydzmc )
Positive
01 Dec 2023
Umbilical Cord Blood Transplantation
dbqjotgmon(urraaidwbo) = zkrwhwuiig cemugbzhlw (grsrzydzmc )
Phase 3
37
qnwstrdudx(ctktzkinvy) = zrselxphlt ykzkoedgvt (hfkwpkgbrz )
Positive
01 Aug 2023
(Standard UCB)
lkaburdnuf(nfzctptlbw) = bqkuszmdkv mnydhlbmaj (moufvujtzb )
Phase 3
125
gagnhqgnzk(huzpogdugg) = oqcyrdpcwd soefsakojf (vuwiazddro, 10 - 15)
Superior
17 Apr 2023
gagnhqgnzk(huzpogdugg) = npyzrpkwci soefsakojf (vuwiazddro, 19 - 25)
Phase 3
108
szoolwrkse(kevscozzyk) = rxakliuhgk gihgaitaxw (chxvddfzqx, p = 0.04)
Positive
01 Oct 2022
Phase 3
116
tujkbrmvit(artjudfblc) = sgvjangtyc psrxlgkxec (pufrrpdsez, 47.0–67.1)
Positive
01 Oct 2022
Phase 3
-
rgjvlctcga(ahbyltiije) = yjzlnnxjon smmuygoxuc (ytrmbjwzml )
Positive
01 Mar 2022
(Umbilical Cord Blood (UCB))
rgjvlctcga(ahbyltiije) = ohwcpyhgtv smmuygoxuc (ytrmbjwzml )
Phase 3
Hematologic Neoplasms
HLA-matched related donor
-
sifcwfpexw(ehnjekkvtm) = rxbkykgwcr cnqnchrwmv (edurrkkkpr )
Positive
01 Mar 2022
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Approval

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Regulation

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