FDA批准了首个细胞疗法Omisirge，用于6岁及以上患者的严重再生障碍性贫血。 FDA approves first cell therapy, Omisirge, for severe aplastic anemia in patients six and older.

林业发展局于2025年12月5日批准Omisimorge(omidubicel-onlv)为六岁及六岁以上患者经降低强度后患重塑性贫血症的第一个细胞疗法(SAA)。 The FDA approved Omisirge (omidubicel-onlv) on December 5, 2025, as the first cell therapy for severe aplastic anemia (SAA) in patients aged six and older following reduced-intensity conditioning. 根据目前由NIH牵头进行的一项研究的数据,19名抗治疗的SAA病人中有95%在8天的中位数内迅速恢复了中位数,94%没有疾病,总体存活率达到94%。 Based on data from an ongoing NIH-led study, 95% of 19 treatment-resistant SAA patients achieved rapid neutrophil recovery in a median of 8 days, with 94% disease-free and overall survival. 只有16%的人患有轻度急性移植 -- -- 逆向 -- -- 宿主疾病,没有严重或慢性病例报告。 Only 16% experienced mild acute graft-versus-host disease, with no severe or chronic cases reported. 这一疗法由Ayrmid Ltd和Gamida Cell Inc.开发,为缺乏匹配的兄弟姐妹捐赠者的病人提供了一个有希望的选择。 The therapy, developed by Ayrmid Ltd. and Gamida Cell Inc., offers a promising option for patients lacking matched sibling donors.