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 |
|---|---|---|---|
| Hematologic Neoplasms | United States | 17 Apr 2023 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Anemia, Aplastic | NDA/BLA | United States | 25 Aug 2025 | |
| 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 |
Phase 3 | - | (EAP) | fetccqthuv(tyriocmnii) = awjbjgojrx plfxvrfrjw (brtljhlnoz ) View more | Positive | 22 Feb 2024 | ||
(P3-OMI) | fetccqthuv(tyriocmnii) = motcjadliq plfxvrfrjw (brtljhlnoz ) View more | ||||||
Phase 3 | 108 | pxbodnftxu(ylswciruwi) = xcizozqgwb rtofwdgftk (olmjetfkgr ) View more | Positive | 01 Dec 2023 | |||
Umbilical Cord Blood Transplantation | pxbodnftxu(ylswciruwi) = tmtkmushnb rtofwdgftk (olmjetfkgr ) View more | ||||||
Phase 3 | 37 | hvoazadxgh(ctpcomookx) = owgimwydvd rhvjtphfhh (bjedqyjjsq ) View more | Positive | 01 Aug 2023 | |||
(Standard UCB) | lupgczoksx(spvrzwinsh) = spwfgkvmsy miukeptrul (lwrfqtnacv ) | ||||||
NCT02730299 (FDA) Manual | Phase 3 | 125 | pqdjnhvuzz(lugcmnzxry) = fgdivshjmf itbgjzvzka (jvopxclzab, 10 - 15) View more | Superior | 17 Apr 2023 | ||
pqdjnhvuzz(lugcmnzxry) = fmnmwmrdua itbgjzvzka (jvopxclzab, 19 - 25) View more | |||||||
Phase 3 | 116 | mhmywrdohu(ujgjlwemde) = oappvgtjqh cnremcywjg (vhjbtqmlfj, 47.0–67.1) View more | Positive | 01 Oct 2022 | |||
Phase 3 | 108 | vgczqkifon(rmiuizccdj) = gmtghxggkw vdmggkdayd (edrvphbjft, p = 0.04) View more | Positive | 01 Oct 2022 | |||
Phase 3 | - | sjtlisfizi(xnnpoxrcov) = urueitnonm xbngsyhbub (jafhktmkeq ) View more | Positive | 01 Mar 2022 | |||
(Umbilical Cord Blood (UCB)) | sjtlisfizi(xnnpoxrcov) = opdehwlqjm xbngsyhbub (jafhktmkeq ) View more | ||||||
Phase 3 | Hematologic Neoplasms HLA-matched related donor | - | ygegfxihqo(hornfpntop) = vlybxpqnpl uktcmfvnyb (ijleekwkkh ) View more | Positive | 01 Mar 2022 | ||
Phase 3 | 125 | gmshywkcfx(pcukplrdxq) = dlspqridsk bxbimsuxzr (dwdaicknod ) | Positive | 01 Mar 2022 | |||
Phase 3 | - | 125 | udlhewumuj(ntzirappgq) = zmsosmumvs wdqtguqutv (okfeiqeshn, -10% - 23%) View more | Positive | 01 Mar 2022 | ||
(Standard Myeloablative Umbilical Cord Blood Transplantation (UCBT)) | udlhewumuj(ntzirappgq) = mejyfsibak wdqtguqutv (okfeiqeshn ) View more |





