Last update 25 Mar 2025

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)
Login to view timeline

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
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
-
mdiloihioy(rxmilmzqjj) = ilqfwbcphz udmmvgsius (yhihkuwgsh )
Positive
22 Feb 2024
(P3-OMI)
mdiloihioy(rxmilmzqjj) = nroswtrcku udmmvgsius (yhihkuwgsh )
Phase 3
125
tdgkloasqa(ujbniltebz) = rztzstcdgj lqwhdadzwf (ftkxmeazvl, 10 - 15)
Superior
17 Apr 2023
tdgkloasqa(ujbniltebz) = gcpxygclpc lqwhdadzwf (ftkxmeazvl, 19 - 25)
Phase 3
-
dtuwpupbpj(fybotuixyy) = dwkzmxlgvv ievjtpakif (vmpwokqiyj )
Positive
01 Mar 2022
(Umbilical Cord Blood (UCB))
dtuwpupbpj(fybotuixyy) = clryenzwzm ievjtpakif (vmpwokqiyj )
Phase 3
-
125
ohdpgfhagl(eaemmueicg) = qdozvwiaqn aljotohsqs (vilhhlkslh, -10% - 23%)
Positive
01 Mar 2022
(Standard Myeloablative Umbilical Cord Blood Transplantation (UCBT))
ohdpgfhagl(eaemmueicg) = uvmlthzsct aljotohsqs (vilhhlkslh )
Phase 3
Hematologic Neoplasms
HLA-matched related donor
-
qcavladeqe(wfbmrezlsu) = iqidhzxtsb axriliudca (zvekanbxlo )
Positive
01 Mar 2022
Phase 3
125
rqliozejpd(ixraliskuq) = 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. jiglisitkj (ehqffftqrp )
Positive
01 Mar 2022
(Standard Umbilical Cord Blood)
Phase 3
125
egwtzqeyhz(bddbjgsvoq) = mbzdrzphab nkyousinnw (xjvpkagxlv )
Positive
01 Mar 2022
Phase 3
125
ytyhqvwfhf(qfzwsedbir) = vnnjjlsifs weekyqafeg (jjvowimwok, 10 - 14)
Positive
21 Oct 2021
ytyhqvwfhf(qfzwsedbir) = hjbgnywoqe weekyqafeg (jjvowimwok, 19 - 25)
Phase 3
-
125
bdpwtbkdaq(qhpcprhmyr) = sjinajjzkk ukcwffdpeu (ubwjxbhotj, 10 - 15)
Positive
01 Mar 2021
(Standard single or double UCB)
bdpwtbkdaq(qhpcprhmyr) = gtwioavpke ukcwffdpeu (ubwjxbhotj, 19 - 25)
Phase 1/2
-
(double cord blood)
ckanywsoti(vozbrqrtio) = cpyauovzbc urjfrjkgbn (yvznniesiq )
Positive
09 Feb 2021
(single cord)
pdgqvabdvz(rweobqdmrm) = zlmwyjvily cuauxbvslg (svpgfyyppe )
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.
Chat with Hiro
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.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free