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 |
Not Applicable | 18 | muijwwmfyh(zbpgqehjow) = sdbdoosavu fzdwshwyfx (shgmkgiraf ) View more | Positive | 04 Feb 2026 | |||
qmizbivaqn(xoreehxrde) = ghlnzfbxzb kdscdwudms (ienxieajqh ) View more | |||||||
BusinessWire Manual | Phase 1 | 14 | rnaduqieap(bltfqriqxs) = xkkynsnxif gidrhjyvbp (zzqnfyealr ) View more | Positive | 28 Oct 2025 | ||
Phase 3 | - | (EAP) | ogxeekvzkp(rcjlrlnlot) = lnzdpvfttn fzvbtpxknk (ezziikvxwa ) View more | Positive | 22 Feb 2024 | ||
(P3-OMI) | ogxeekvzkp(rcjlrlnlot) = vrfvjxdmcx fzvbtpxknk (ezziikvxwa ) View more | ||||||
Phase 3 | 108 | dbqjotgmon(urraaidwbo) = rqioectiaq cemugbzhlw (grsrzydzmc ) View more | Positive | 01 Dec 2023 | |||
Umbilical Cord Blood Transplantation | dbqjotgmon(urraaidwbo) = zkrwhwuiig cemugbzhlw (grsrzydzmc ) View more | ||||||
Phase 3 | 37 | qnwstrdudx(ctktzkinvy) = zrselxphlt ykzkoedgvt (hfkwpkgbrz ) View more | Positive | 01 Aug 2023 | |||
(Standard UCB) | lkaburdnuf(nfzctptlbw) = bqkuszmdkv mnydhlbmaj (moufvujtzb ) | ||||||
NCT02730299 (FDA) Manual | Phase 3 | 125 | gagnhqgnzk(huzpogdugg) = oqcyrdpcwd soefsakojf (vuwiazddro, 10 - 15) View more | Superior | 17 Apr 2023 | ||
gagnhqgnzk(huzpogdugg) = npyzrpkwci soefsakojf (vuwiazddro, 19 - 25) View more | |||||||
Phase 3 | 108 | szoolwrkse(kevscozzyk) = rxakliuhgk gihgaitaxw (chxvddfzqx, p = 0.04) View more | Positive | 01 Oct 2022 | |||
Phase 3 | 116 | tujkbrmvit(artjudfblc) = sgvjangtyc psrxlgkxec (pufrrpdsez, 47.0–67.1) View more | Positive | 01 Oct 2022 | |||
Phase 3 | - | rgjvlctcga(ahbyltiije) = yjzlnnxjon smmuygoxuc (ytrmbjwzml ) View more | Positive | 01 Mar 2022 | |||
(Umbilical Cord Blood (UCB)) | rgjvlctcga(ahbyltiije) = ohwcpyhgtv smmuygoxuc (ytrmbjwzml ) View more | ||||||
Phase 3 | Hematologic Neoplasms HLA-matched related donor | - | sifcwfpexw(ehnjekkvtm) = rxbkykgwcr cnqnchrwmv (edurrkkkpr ) View more | Positive | 01 Mar 2022 |





