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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-024-02990-z

摘要内容如下：

首次完成的诱导多能干细胞（iPS细胞）衍生细胞的临床试验在15名患有激素耐药急性移植物抗宿主病的参与者中进行。在静脉输注间充质基质细胞（来源于人类iPS细胞克隆的CYP-001）后，我们报告了在第100天的主要评估期内的安全性、耐受性和有效性。我们现在报告了2年随访的结果:15名参与者中有9名（60%）存活，这与先前报道的激素耐药性急性移植物抗宿主病的研究结果相比是有利的。死亡原因是异基因造血干细胞移植受者中常见的并发症，研究者认为与CYP-001治疗无关。没有与CYP-001相关的严重不良事件、肿瘤或其他安全问题。总之，在2年的随访中，iPS细胞来源的细胞的全身递送是安全的，并且耐受性良好，在第一次输注后的2年内具有持续的结果。ClinicalTrials.gov注册：NCT02923375。

英文原文如下：

Abstracts

The first completed clinical trial of induced pluripotent stem cell (iPS cell)-derived cells was conducted in 15 participants with steroid-resistant acute graft-versus-host disease. After intravenous infusion of mesenchymal stromal cells (CYP-001 derived from a clone of human iPS cells), we reported the safety, tolerability and efficacy within the primary evaluation period at day 100. We now report results at the 2-year follow-up: 9 of 15 (60%) participants survived, which compares favorably with previously reported outcomes in studies of steroid-resistant acute graft-versus-host disease. Causes of death were complications commonly observed in recipients of allogeneic hematopoietic stem cell transplantation, and not considered by the investigators to be related to CYP-001 treatment. There were no serious adverse events, tumors or other safety concerns related to CYP-001. In conclusion, systemic delivery of iPS cell-derived cells was safe and well tolerated over 2 years of follow-up, with sustained outcomes up to 2 years after the first infusion. ClinicalTrials.gov registration: NCT02923375 .

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