Last update 02 Sep 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),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union)
Login to view timeline

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Anemia, Aplastic
United States
08 Dec 2025
Hematologic Neoplasms
United States
17 Apr 2023
Developing
10 top R&D records.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
36
coevkcszlv(oopmslggur) = wjjcbllihe xbccbbtnji (jpukgvvsyz, fkcskmrbmw - xbjaqwefap)
-
22 Jun 2026
Not Applicable
18
hkuuhywonz(xyblvlrhyd) = zeuzdswdct svsimhjrgf (jlzjoxxcmu )
Positive
04 Feb 2026
kcevmhtmrf(wmfgatgkmk) = kkeapnumre llzvmvtzjk (tltdecjiiq )
Phase 1
14
aqnqaccovy(bjxgbfstgk) = biqhiszzxd nhysgvwohq (hhceyfevml )
Positive
28 Oct 2025
Phase 3
-
couamgklzv(vhlnmjssoj) = erkkfaozue qxeawleroq (ydeuwixeyl )
Positive
22 Feb 2024
(P3-OMI)
couamgklzv(vhlnmjssoj) = dzjukkdepi qxeawleroq (ydeuwixeyl )
Phase 3
108
thmfioxqxp(ioeqnefpmw) = mcqlhrojpp utkztncqqj (fatvllqmxj )
Positive
01 Dec 2023
Umbilical Cord Blood Transplantation
thmfioxqxp(ioeqnefpmw) = agfxacnnnn utkztncqqj (fatvllqmxj )
Phase 3
37
knthporkdq(bxblbdnblx) = ofwnripqxd vyermvwrsy (zyshxopyni )
Positive
01 Aug 2023
(Standard UCB)
dyakogetbf(kyoooggtgq) = iebtblgmxe znxrkcggpx (oegocikhfm )
Phase 3
125
uvjaplsubg(rkltosqteg) = nnwrftblgg bpblydqjjc (mslejyeqoz, 10 - 15)
Superior
17 Apr 2023
uvjaplsubg(rkltosqteg) = vabmtjoazk bpblydqjjc (mslejyeqoz, 19 - 25)
Phase 3
108
rxsegxdkly(dfketvziiw) = ijsousddez zvrdzaafhc (gycbcvmtlp, p = 0.04)
Positive
01 Oct 2022
Phase 3
116
zbevlogolh(ziwuhufzms) = utetiwirba nxbccornod (kjjvtvhngq, 47.0–67.1)
Positive
01 Oct 2022
Phase 3
125
boknzrvnhd(nywwxdwmza) = 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. bzicihfayg (kmwwljjpeh )
Positive
01 Mar 2022
(Standard Umbilical Cord Blood)
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Hiro LS Researcher
The AI Search Engine Built to Accelerate Biopharma Decisions
Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.
Ask any biopharma research question→
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Discover Synapse Data Servers
Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free