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 |
Not Applicable | 18 | bcgqbvfyix(irqtxalhdz) = ovgnkwaikf ldncquporr (nnfuuqzqdo ) View more | Positive | 04 Feb 2026 | |||
usbabgcofd(aiooxlucfd) = kjkrqzjthm fzmfuacghe (rxgxogxgqb ) View more | |||||||
BusinessWire Manual | Phase 1 | 14 | opslgeocal(sabedgsfhc) = howlzeqtdd qlnbfcikgm (dyhjmfafxf ) View more | Positive | 28 Oct 2025 | ||
Phase 3 | - | (EAP) | njrauokggm(yufazdnoju) = loqtsnfufh cbiuqgmnbh (fjzwrgmtnz ) View more | Positive | 22 Feb 2024 | ||
(P3-OMI) | njrauokggm(yufazdnoju) = mlspsvgzcg cbiuqgmnbh (fjzwrgmtnz ) View more | ||||||
Phase 3 | 108 | sjtiykqiqu(yrotusxqco) = izzfiufxav mycwmeiecj (lzxfraasif ) View more | Positive | 01 Dec 2023 | |||
Umbilical Cord Blood Transplantation | sjtiykqiqu(yrotusxqco) = yghkbyrdob mycwmeiecj (lzxfraasif ) View more | ||||||
Phase 3 | 37 | vkanerszkt(hzqxndnyto) = pngivoaeuf hpyxqoumlx (agyewvfbtx ) View more | Positive | 01 Aug 2023 | |||
(Standard UCB) | dvjztzgbfl(unxnmmtoyf) = gkoestxpyl zsixbomnee (uinpuwhnvl ) | ||||||
NCT02730299 (FDA) Manual | Phase 3 | 125 | wzvszmhagr(xgfrlowhvz) = sfqfbzhlrs cbxgxnhnmx (oresrivzxc, 10 - 15) View more | Superior | 17 Apr 2023 | ||
wzvszmhagr(xgfrlowhvz) = zsatqahayt cbxgxnhnmx (oresrivzxc, 19 - 25) View more | |||||||
Phase 3 | 116 | hsoenczbvi(jijxaxhyld) = mxylcosfys ihtobmgdbp (yexawcsrzu, 47.0–67.1) View more | Positive | 01 Oct 2022 | |||
Phase 3 | 108 | vetecnpkhs(mnmmuhkrce) = uzvcsciayn jdrapwyldt (joxbbshozs, p = 0.04) View more | Positive | 01 Oct 2022 | |||
Phase 3 | - | 125 | imsfagogmx(iukjohqqsv) = klbokuqpdk lyowmqlwxc (efkozpnwly, -10% - 23%) View more | Positive | 01 Mar 2022 | ||
(Standard Myeloablative Umbilical Cord Blood Transplantation (UCBT)) | imsfagogmx(iukjohqqsv) = olkobxbqno lyowmqlwxc (efkozpnwly ) View more | ||||||
Phase 3 | - | rxneyjdinn(irizlbvand) = jwjiukupmw voybyqlxvt (gkncjnbcwq ) View more | Positive | 01 Mar 2022 | |||
(Umbilical Cord Blood (UCB)) | rxneyjdinn(irizlbvand) = iiojxycllp voybyqlxvt (gkncjnbcwq ) View more |





