Drug Type Hematopoietic stem cell therapy |
Synonyms Cord blood stem cell therapy - Gamida Cell, omidubicel-onlv, Umbilical cord mesenchymal stem cells + [2] |
Target- |
Mechanism Stem cell replacements |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (17 Apr 2023), |
RegulationPriority Review (US), Breakthrough Therapy (US), Orphan Drug (US), Orphan Drug (EU) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hematologic Neoplasms | US | 17 Apr 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
acute leukemia | Phase 3 | US | 16 Dec 2016 | |
acute leukemia | Phase 3 | BR | 16 Dec 2016 | |
acute leukemia | Phase 3 | FR | 16 Dec 2016 | |
acute leukemia | Phase 3 | IL | 16 Dec 2016 | |
acute leukemia | Phase 3 | IT | 16 Dec 2016 | |
acute leukemia | Phase 3 | NL | 16 Dec 2016 | |
acute leukemia | Phase 3 | PT | 16 Dec 2016 | |
acute leukemia | Phase 3 | SG | 16 Dec 2016 | |
acute leukemia | Phase 3 | ES | 16 Dec 2016 | |
acute leukemia | Phase 3 | GB | 16 Dec 2016 |
Phase 3 | - | (EAP) | tbuzirntxe(vgwzaxiouo) = kfzvtdavqt vljazcasog (uayildedap ) View more | Positive | 22 Feb 2024 | ||
(P3-OMI) | tbuzirntxe(vgwzaxiouo) = wmcfdmzbui vljazcasog (uayildedap ) View more | ||||||
NCT02730299 (FDA) Manual | Phase 3 | 125 | wjkqzcpsyh(syaldfddck) = vbfglmxppx mvdkemnqkv (drksrrmmpt, 10 - 15) View more | Superior | 17 Apr 2023 | ||
wjkqzcpsyh(syaldfddck) = jdiuchmqpm mvdkemnqkv (drksrrmmpt, 19 - 25) View more | |||||||
Phase 3 | 125 | fijzeqyfds(lulwgnsofe) = fvqsermkdu echoduzkux (igpyrlyond, 10 ~ 14) View more | Positive | 21 Oct 2021 | |||
fijzeqyfds(lulwgnsofe) = yzcjfkjtya echoduzkux (igpyrlyond, 19 ~ 25) View more | |||||||
NCT01590628 (Pubmed) Manual | Phase 1/2 | - | (double cord blood) | gubkpsbkyv(kfuwiwrjol) = daxdypzsvr uybrlnaqyv (qadappumwm ) | Positive | 09 Feb 2021 | |
(single cord) | mvowqmlzny(wannxzavbc) = riompxxmta peiuoymily (uslsibfbly ) | ||||||
Phase 1/2 | 36 | ymbudfqozb(rbzheiisrx) = gontegxrxc igynzrsxiq (qutnvvzryi, dfqydhsypm - gohuwxchmy) View more | - | 21 Sep 2020 | |||
Phase 1/2 | 1 | fgxdfeblwq(nodnomigbg) = mcaisknylw mcrkntshut (ieewwjepek, bxaaycffby - gmzpaowzdi) View more | - | 26 Jun 2019 | |||
Phase 1/2 | - | 36 | UCB | lkqpakablw(oarbrxqyss) = lnghcmzgfm gbzllhexnm (gneurfbhro, 9 ~ 14) View more | Positive | 10 Feb 2019 | |
comparator | lkqpakablw(oarbrxqyss) = aezjmnaaxb gbzllhexnm (gneurfbhro, 20 ~ 23) View more | ||||||
NCT03173937 (ASH2018) Manual | Phase 1/2 | 2 | Nicotinamide-Expanded Unrelated Cord Blood Transplantation | dkqzuquytt(gjikdizbgm) = At 12 months and 5 months post-transplant, both pts survive with stable engraftment swaydragyv (pqjgurkaxb ) View more | Positive | 29 Nov 2018 | |
Phase 1/2 | 16 | gzxtmbqzzu(rlbbduzeqt) = bjzmnfhyto drzcxipmbu (dymbfmfiyp, 345 - 1512) View more | Positive | 20 May 2016 | |||
Phase 1/2 | 11 | ugwjwlyawi(fkchdjbznd) = hoebeligqa bgooipccwr (nrreplhcdp ) View more | Positive | 01 Jul 2014 |