May 2023: Omidubicel-onlv (Omisirge, Gamida Cell Ltd.) oziq-ovqat va farmatsevtika idorasi tomonidan miyeloablativ konditsionerdan so'ng kindik qoni ko'chirib o'tkazilishi rejalashtirilgan gematologik malign o'smalari bo'lgan kattalar va bolalarda (12 yosh va undan katta) foydalanish uchun tasdiqlangan. neytrofillarning tiklanishini tezlashtirish va infektsiya xavfini kamaytirish uchun.
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.
Retsept bo'yicha material o'limga olib keladigan yoki hayotga xavf soladigan infuzion reaktsiyalar, greft versus host kasalligi (GvHD), engraftment sindromi va ruxsat etilgan UCB dori vositalariga o'xshash transplantatsiya etishmovchiligi uchun qutidagi ogohlantirishni o'z ichiga oladi. Omidubicel-onlv har qanday kasallik uchun 117 kishiga kiritilgan; Ulardan 47% infuzion reaktsiyalarni boshdan kechirgan, 58% o'tkir GVHD, 35% surunkali GVHD va 3% greft etishmovchiligini boshdan kechirgan.
P3 tadqiqotida gematologik xavfli o'smalari bo'lgan bemorlarning 5-0501-darajali eng tez-tez uchraydigan salbiy reaktsiyalari og'riq (33%), shilliq qavatning yallig'lanishi (31%), gipertoniya (25%) va oshqozon-ichak traktining toksikligi (19%) edi.
Tavsiya etilgan omidubisel-onlv dozasi quyidagilardan iborat ikkita ketma-ket infuziya:
- Madaniyatli fraksiya: kamida 8.0 × 108 kamida 8.7% CD34+ hujayralari va kamida 9.2 × 10 bo'lgan jami tirik hujayralar7 jami CD34+ hujayralar, undan keyin
- Madaniyatsiz fraksiya: kamida 4.0 × 108 kamida 2.4 × 10 bo'lgan jami tirik hujayralar7 CD3+ hujayralar.
Omisirge uchun retsept bo'yicha to'liq ma'lumot bu erda mavjud bo'ladi.
