Phan Thanh G, Ma Henry, Lim Rebecca, Sobey Christopher G, Wallace Euan M
Clinical Trials, Imaging and Informatics (CTI) Division, Stroke & Ageing Research (STARC), Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
The Ritchie Centre, Department of Obstetrics and Gynaecology, Hudson Institute of Medical Research, Monash Health and Monash University, Melbourne, VIC, Australia.
Front Neurol. 2018 Jun 7;9:198. doi: 10.3389/fneur.2018.00198. eCollection 2018.
There is increasing interest in stem cell therapy as another treatment modality in stroke, particularly for patients who are unable to receive endovascular clot retrieval or thrombolysis therapies, or for whom standard treatment has failed. We have recently shown that human amniotic epithelial cells (hAECs) are effective in reducing infarct volume in different animal models of ischemic stroke, including in non-human primates. hAEC therapy attenuated infarct growth and/or promoted functional recovery, even when administered 1-3 days after the onset of stroke.
We now propose an open label Phase 1 dose escalation trial to assess the safety of allogeneic hAECs in stroke patients with a view to providing an evidence platform for future Phase 2 efficacy trials. We propose a modified 3 + 3 dose escalation study design with additional components for measuring magnetic resonance signal of efficacy as well as the effect of hAECs on immunosuppression after stroke.
The trial will commence in 2018. The findings will be published in a peer-reviewed journal.
The trial is registered with ANZCTR (ACTRN12618000076279p).
干细胞疗法作为中风的另一种治疗方式，正受到越来越多的关注，特别是对于那些无法接受血管内血栓清除或溶栓治疗，或标准治疗失败的患者。我们最近发现，人羊膜上皮细胞（hAECs）在不同的缺血性中风动物模型中，包括在非人类灵长类动物中，能有效减少梗死体积。即使在中风发作后1 - 3天给药，hAEC疗法也能减轻梗死灶扩大和/或促进功能恢复。
我们现在提议开展一项开放标签的1期剂量递增试验，以评估同种异体hAECs在中风患者中的安全性，为未来的2期疗效试验提供证据平台。我们提议采用改良的3 + 3剂量递增研究设计，并增加用于测量疗效磁共振信号以及hAECs对中风后免疫抑制影响的额外组成部分。
该试验将于2018年开始。研究结果将发表在同行评审的期刊上。
该试验已在澳大利亚和新西兰临床试验注册中心注册（注册号：ACTRN12618000076279p）。
