Mungkin 2023: Omidubicel-onlv (Omisirge, Gamida Cell Ltd.) disatujuan ku Administrasi Pangan sareng Narkoba pikeun dianggo dina pasien dewasa sareng murangkalih (umur 12 taun sareng langkung lami) kalayan malignancies hematologis anu dijadwalkeun nampi cangkok getih umbilical cord saatos udar myeloablative. pikeun nyepetkeun pamulihan neutrofil sareng ngirangan résiko inféksi.
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.
Bahan resep kalebet Perhatosan Kotak pikeun réaksi infus anu maot atanapi ngancam kahirupan, graft versus host disease (GvHD), sindrom engraftment, sareng gagal korupsi, sami sareng obat UCB anu otorisasi. Omidubicel-onlv ieu dikaluarkeun pikeun 117 individu pikeun sagala panyakit; di antarana, 47% ngalaman réaksi infus, 58% ngalaman GVHD akut, 35% ngalaman GVHD kronis, sarta 3% ngalaman gagal tandur.
Réspon ngarugikeun Kelas 3-5 anu paling sering dina penderita Study P0501 kalayan malignancies hematologis nyaéta nyeri (33%), peradangan mukosa (31%), hipertensi (25%), sareng karacunan gastrointestinal (19%).
Dosis omidubicel-onlv anu disarankeun nyaéta dua infus berurutan anu diwangun ku ieu:
- Fraksi Budaya: minimum 8.0 × 108 total sél giat kalayan minimum 8.7 persén CD34+ sél jeung minimum 9.2 × 107 total sél CD34+, dituturkeun ku
- Fraksi Non-budaya: minimum 4.0 × 108 total sél hirup kalawan minimum 2.4 × 107 sél CD3+.
Inpormasi resep lengkep pikeun Omisirge bakal sayogi di dieu.
