Peringatan Keamanan

Toxicity information regarding omidubicel is not readily available. Patients experiencing an overdose are at an increased risk of severe adverse effects such as severe infusion reactions and graft-versus-host disease (GVHD).L46048 Symptomatic and supportive measures are recommended.

Omidubicel

DB17132

biotech approved investigational

Deskripsi

Omidubicel is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood used as an allogeneic stem cell donor source. Umbilical blood cord cells are expanded ex-vivo and nicotinamide (a form of vitamin B3) is used as an active agent in the culture system to inhibit the differentiation and increase the functionality of hematopoietic stem and progenitor cells.A258938,A258943,L46048 This type of cell therapy benefits patients that require stem cell transplantation as a treatment for blood cancers for whom a related or unrelated donor cannot be found due to the requirement of high-grade human leukocyte antigen (HLA)-matching. In this group of patients, umbilical cord blood can be used as an alternative cell source since there is a lower risk of graft failure or graft-versus-host disease, even with low-grade HLA-matching.A258948

A pooled analysis of five prospective clinical trials found that the use of omidubicel led to stable trilineage hematopoiesis, immune competence, and graft durability in extended follow-up. In addition, the fact that 39% of the study's cohort were non-White patients highlights the importance of this type of treatment in key demographics with low donor availability.A258958 In April 2023, the FDA approved the use of omidubicel in adults and pediatric patients 12 years and older with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen. It is administered as a single intravenous dose specific to each patient.L46048,L46058

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: ObatTargetGenEnzim(Panah → menunjukkan arah efek / relasi)TransporterCarrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) There is limited pharmacokinetic information on omidubicel.
Volume Distribusi There is limited pharmacokinetic information on omidubicel.
Klirens (Clearance) There is limited pharmacokinetic information on omidubicel.

Absorpsi

There is limited pharmacokinetic information on omidubicel.

Metabolisme

There is limited pharmacokinetic information on omidubicel.

Rute Eliminasi

There is limited pharmacokinetic information on omidubicel.

Interaksi Obat

0 Data
Tidak ada data.

Referensi & Sumber

Synthesis reference: Peled, T., et al. (2011). Expansion of renewable stem cell populations (U.S. Patent No. 7,955,852 B2). U.S. Patent and Trademark Office. https://patentimages.storage.googleapis.com/55/39/b0/98823954f3bdba/US7955852.pdf
Artikel (PubMed)
  • PMID: 24911148
    Horwitz ME, Chao NJ, Rizzieri DA, Long GD, Sullivan KM, Gasparetto C, Chute JP, Morris A, McDonald C, Waters-Pick B, Stiff P, Wease S, Peled A, Snyder D, Cohen EG, Shoham H, Landau E, Friend E, Peleg I, Aschengrau D, Yackoubov D, Kurtzberg J, Peled T: Umbilical cord blood expansion with nicotinamide provides long-term multilineage engraftment. J Clin Invest. 2014 Jul;124(7):3121-8. doi: 10.1172/JCI74556. Epub 2014 Jun 9.
  • PMID: 34157093
    Horwitz ME, Stiff PJ, Cutler C, Brunstein C, Hanna R, Maziarz RT, Rezvani AR, Karris NA, McGuirk J, Valcarcel D, Schiller GJ, Lindemans CA, Hwang WYK, Koh LP, Keating A, Khaled Y, Hamerschlak N, Frankfurt O, Peled T, Segalovich I, Blackwell B, Wease S, Freedman LS, Galamidi-Cohen E, Sanz G: Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021 Oct 21;138(16):1429-1440. doi: 10.1182/blood.2021011719.
  • PMID: 34312498
    de Koning C, Tao W, Lacna A, van Veghel K, Horwitz ME, Sanz G, Jagasia MH, Wagner JE, Stiff PJ, Hanna R, Cilloni D, Valcarcel D, Peled T, Galamidi Cohen E, Goshen U, Pandit A, Lindemans CA, Jan Boelens J, Nierkens S: Lymphoid and myeloid immune cell reconstitution after nicotinamide-expanded cord blood transplantation. Bone Marrow Transplant. 2021 Nov;56(11):2826-2833. doi: 10.1038/s41409-021-01417-4. Epub 2021 Jul 26.
  • PMID: 36775201
    Lin C, Schwarzbach A, Sanz J, Montesinos P, Stiff P, Parikh S, Brunstein C, Cutler C, Lindemans CA, Hanna R, Koh LP, Jagasia MH, Valcarcel D, Maziarz RT, Keating AK, Hwang WYK, Rezvani AR, Karras NA, Fernandes JF, Rocha V, Badell I, Ram R, Schiller GJ, Volodin L, Walters MC, Hamerschlak N, Cilloni D, Frankfurt O, McGuirk JP, Kurtzberg J, Sanz G, Simantov R, Horwitz ME: Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials. Transplant Cell Ther. 2023 Feb 10:S2666-6367(23)01071-0. doi: 10.1016/j.jtct.2023.01.031.

Contoh Produk & Brand

Produk: 2 • International brands: 1
Produk
  • Omisirge
    Kit; Suspension • - • Intravenous • US • Approved
  • Omisirge
    Kit; Suspension • - • Intravenous • US • Approved
International Brands
  • Omisirge — Gamida Cell Inc.

Sekuens Gen/Protein (FASTA)

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