Omidubicel inotenderwa neUSFDA kuderedza nguva yekupora neutrophil uye kutapukira kune varwere vane hematologic malignancies.

May 2023: Omidubicel-onlv (Omisirge, Gamida Cell Ltd.) yakatenderwa neChikafu neDrug Administration kuti ishandiswe muvakuru nevana varwere (makore gumi nemaviri ezera zvichikwira) vane hematologic malignancies avo vakarongerwa kugamuchira umbilical cord kuisirwa ropa mushure memyeloblative conditioning. kuitira kukurumidza kupora neutrophil uye kuderedza njodzi yehutachiona.

In Study P0501 (NCT02730299), an open-label, multicenter, randomised trial of omidubicel-onlv transplantation or unmanipulated cord blood (UCB) unit transplantation after myeloablative conditioning in patients with hematologic malignancies, the effectiveness and safety of the treatments were assessed. A total of 125 individuals were randomly assigned, with 62 receiving omidubicel-onlv and 63 receiving UCB. 52 patients had omidubicel-onlv transplantation, with a median dose of 9.0 X 106 cells/kg (range 2.1 – 47.6 X 106 cells/kg) of CD34+ cells. In the UCB arm, 56 patients had one or two cord units (66% received two cord units) implanted. The median CD34+ cell dose in the 42 patients who had post-thaw cell doses recorded was 0.2 X 106 cells/kg (range 0.0 – 0.8 X 106 cells/kg). There were other conditioning protocols utilised, such as those based on chemotherapy or Total Body Irradiation.

Time to neutrophil recovery after transplantation and the frequency of Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Grade 2/3 bacterial or Grade 3 fungal infections through Day 100 after transplantation were the primary efficacy outcome measures. The median time to neutrophil recovery was 12 days (95% CI: 10-15 days) for those receiving omidubicel-onlv, and 22 days (95% CI: 19-25 days) for those receiving UCB. In the omidubicel-onlv arm, 87% of patients and 83% of those receiving UCB experienced neutrophil recovery. Through Day 100 after transplantation, the incidence of BMT CTN Grade 2/3 bacterial or Grade 3 fungal infections was 39% and 60%, respectively, in the two groups.

Zvinhu zvinonyorerwa zvinosanganisira Bhokisi Yambiro yezvinouraya kana kutyisidzira upenyu infusion reactions, graft versus host disease (GvHD), engraftment syndrome, uye graft kukundikana, zvakafanana neiyo yemvumo yeUCB mishonga. Omidubicel-onlv yakapiwa kuvanhu 117 kune chero chirwere; vavo, 47% vakawana infusion reactions, 58% vakawana acute GVHD, 35% vane chirwere cheGVHD chisingaperi, uye 3% vakasangana nekukundikana kwegraft.

Mhinduro dzakashata dzeGiredhi 3-5 muChidzidzo P0501 varwere vane hematologic malignancies vaiva marwadzo (33%), mucosal kuzvimba (31%), hypertension (25%), uye gastrointestinal toxicity (19%).

Iyo yakakurudzirwa omidubicel-onlv dose ndeye maviri akateedzana infusions anosanganisira anotevera:

• a Cultured Fraction: mashoma e8.0 × 10⁸ masero akazara anoshanda ane mashoma e8.7 muzana eCD34+ masero uye mashoma e9.2 × 10⁷ akazara maCD34+ masero, achiteverwa ne
• a Isina-yakasimwa Fraction: mashoma e4.0 × 10⁸ masero akazara anoshanda ane hushoma hwe2.4 × 10⁷ CD3+ masero.

Ruzivo ruzere rwekurondedzera rweOmisirge ruchavepo pano.