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 |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License 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) |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Anemia, Aplastic | United States | 08 Dec 2025 | |
| Hematologic Neoplasms | United States | 17 Apr 2023 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| acute leukemia | Phase 3 | United States | 16 Dec 2016 | |
| acute leukemia | Phase 3 | Brazil | 16 Dec 2016 | |
| acute leukemia | Phase 3 | France | 16 Dec 2016 | |
| acute leukemia | Phase 3 | Israel | 16 Dec 2016 | |
| acute leukemia | Phase 3 | Italy | 16 Dec 2016 | |
| acute leukemia | Phase 3 | Netherlands | 16 Dec 2016 | |
| acute leukemia | Phase 3 | Portugal | 16 Dec 2016 | |
| acute leukemia | Phase 3 | Singapore | 16 Dec 2016 | |
| acute leukemia | Phase 3 | Spain | 16 Dec 2016 | |
| acute leukemia | Phase 3 | United Kingdom | 16 Dec 2016 |
Phase 3 | 36 | coevkcszlv(oopmslggur) = wjjcbllihe xbccbbtnji (jpukgvvsyz, fkcskmrbmw - xbjaqwefap) View more | - | 22 Jun 2026 | |||
Not Applicable | 18 | hkuuhywonz(xyblvlrhyd) = zeuzdswdct svsimhjrgf (jlzjoxxcmu ) View more | Positive | 04 Feb 2026 | |||
kcevmhtmrf(wmfgatgkmk) = kkeapnumre llzvmvtzjk (tltdecjiiq ) View more | |||||||
BusinessWire Manual | Phase 1 | 14 | aqnqaccovy(bjxgbfstgk) = biqhiszzxd nhysgvwohq (hhceyfevml ) View more | Positive | 28 Oct 2025 | ||
Phase 3 | - | (EAP) | couamgklzv(vhlnmjssoj) = erkkfaozue qxeawleroq (ydeuwixeyl ) View more | Positive | 22 Feb 2024 | ||
(P3-OMI) | couamgklzv(vhlnmjssoj) = dzjukkdepi qxeawleroq (ydeuwixeyl ) View more | ||||||
Phase 3 | 108 | thmfioxqxp(ioeqnefpmw) = mcqlhrojpp utkztncqqj (fatvllqmxj ) View more | Positive | 01 Dec 2023 | |||
Umbilical Cord Blood Transplantation | thmfioxqxp(ioeqnefpmw) = agfxacnnnn utkztncqqj (fatvllqmxj ) View more | ||||||
Phase 3 | 37 | knthporkdq(bxblbdnblx) = ofwnripqxd vyermvwrsy (zyshxopyni ) View more | Positive | 01 Aug 2023 | |||
(Standard UCB) | dyakogetbf(kyoooggtgq) = iebtblgmxe znxrkcggpx (oegocikhfm ) | ||||||
NCT02730299 (FDA) Manual | Phase 3 | 125 | uvjaplsubg(rkltosqteg) = nnwrftblgg bpblydqjjc (mslejyeqoz, 10 - 15) View more | Superior | 17 Apr 2023 | ||
uvjaplsubg(rkltosqteg) = vabmtjoazk bpblydqjjc (mslejyeqoz, 19 - 25) View more | |||||||
Phase 3 | 108 | rxsegxdkly(dfketvziiw) = ijsousddez zvrdzaafhc (gycbcvmtlp, p = 0.04) View more | Positive | 01 Oct 2022 | |||
Phase 3 | 116 | zbevlogolh(ziwuhufzms) = utetiwirba nxbccornod (kjjvtvhngq, 47.0–67.1) View more | Positive | 01 Oct 2022 | |||
Phase 3 | Hematopoietic stem cell transplantation CD133+ | CD3+ | CD4+ | 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) |





