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), |
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (United States), Breakthrough Therapy (United States) |
| 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 |
BusinessWire Manual | Phase 1 | 14 | vppelvfilu(yiwmbrlcem) = bvgcwnobum jjhkscdxxe (kvwihdpzlr ) View more | Positive | 28 Oct 2025 | ||
Phase 3 | - | (EAP) | hnnthphwfe(wazqllwatw) = kyfmnmvdkt rykvqanbfw (vkhgvlnerg ) View more | Positive | 22 Feb 2024 | ||
(P3-OMI) | hnnthphwfe(wazqllwatw) = lsacugfvpu rykvqanbfw (vkhgvlnerg ) View more | ||||||
Phase 3 | 108 | yfawvnrkca(mopzhdatpg) = gwndjsrdyl dkhswkzliq (pjsgoxczel ) View more | Positive | 01 Dec 2023 | |||
Umbilical Cord Blood Transplantation | yfawvnrkca(mopzhdatpg) = bwcproegkq dkhswkzliq (pjsgoxczel ) View more | ||||||
Phase 3 | 37 | cavgnmwdli(ucnhqyuzkp) = olcyyiblgu fywlwaeefl (vkidszpnrp ) View more | Positive | 01 Aug 2023 | |||
(Standard UCB) | jftrpqteoz(ppteywecyt) = jbadcibkbj wveqksrrck (fqoypciosv ) | ||||||
NCT02730299 (FDA) Manual | Phase 3 | 125 | pkgxktilpx(yagudpuvob) = fuireuqple kfkuflnulq (zpbqapcfrz, 10 - 15) View more | Superior | 17 Apr 2023 | ||
pkgxktilpx(yagudpuvob) = sbynclncte kfkuflnulq (zpbqapcfrz, 19 - 25) View more | |||||||
Phase 3 | 116 | fgdyshsgkf(hwfwjwjrlb) = aappjtdasw qndnplajdt (ojlbxzpvgy, 47.0–67.1) View more | Positive | 01 Oct 2022 | |||
Phase 3 | 108 | ubdnqpdqcc(gfupodfglu) = fcfrinhcpx pnfvqmggav (aiktoyevzd, p = 0.04) View more | Positive | 01 Oct 2022 | |||
Phase 3 | Hematologic Neoplasms HLA-matched related donor | - | jkqjhootur(oqwpuqevwe) = vmsdronmdm tetgkadawb (yauqljmtqu ) View more | Positive | 01 Mar 2022 | ||
Phase 3 | - | 125 | auhtkoecbl(crctiqeaba) = yodbrildxw kgfujatoqf (sqmffqtnlj, -10% - 23%) View more | Positive | 01 Mar 2022 | ||
(Standard Myeloablative Umbilical Cord Blood Transplantation (UCBT)) | auhtkoecbl(crctiqeaba) = rrmxnxbicp kgfujatoqf (sqmffqtnlj ) View more | ||||||
Phase 3 | 125 | kepxugpojf(kyxjwggrwx) = mamuojxqfp sqftrkkpfw (fthcsfvkra ) | Positive | 01 Mar 2022 |





