已入深夜,您辛苦了!由于当前在线用户较少,发布求助请尽量完整地填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!祝你早点完成任务,早点休息,好梦!

Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomised, double-blind, placebo-controlled, phase 2 trial

医学 安慰剂 祖细胞 冲程(发动机) 内科学 骨髓 外科 干细胞 病理 遗传学 机械工程 生物 工程类 替代医学
作者
David C. Hess,Lawrence R. Wechsler,Wayne M. Clark,Sean I. Savitz,Gary A. Ford,David Chiu,Dileep R Yavagal,Ken Uchino,David S. Liebeskind,Alexander P. Auchus,Souvik Sen,Cathy Sila,Jeffrey Vest,Robert Mays
出处
期刊:Lancet Neurology [Elsevier BV]
卷期号:16 (5): 360-368 被引量:319
标识
DOI:10.1016/s1474-4422(17)30046-7
摘要

Background Multipotent adult progenitor cells are a bone marrow-derived, allogeneic, cell therapy product that modulates the immune system, and represents a promising therapy for acute stroke. We aimed to identify the highest, well-tolerated, and safest single dose of multipotent adult progenitor cells, and if they were efficacious as a treatment for stroke recovery. Methods We did a phase 2, randomised, double-blind, placebo-controlled, dose-escalation trial of intravenous multipotent adult progenitor cells in 33 centres in the UK and the USA. We used a computer-generated randomisation sequence and interactive voice and web response system to assign patients aged 18–83 years with moderately severe acute ischaemic stroke and a National Institutes of Health Stroke Scale (NIHSS) score of 8–20 to treatment with intravenous multipotent adult progenitor cells (400 million or 1200 million cells) or placebo between 24 h and 48 h after symptom onset. Patients were ineligible if there was a change in NIHSS of four or more points during at least a 6 h period between screening and randomisation, had brainstem or lacunar infarct, a substantial comorbid disease, an inability to undergo an MRI scan, or had a history of splenectomy. In group 1, patients were enrolled and randomly assigned in a 3:1 ratio to receive 400 million cells or placebo and assessed for safety through 7 days. In group 2, patients were randomly assigned in a 3:1 ratio to receive 1200 million cells or placebo and assessed for safety through the first 7 days. In group 3, patients were enrolled, randomly assigned, and stratified by baseline NIHSS score to receive 1200 million cells or placebo in a 1:1 ratio within 24–48 h. Patients, investigators, and clinicians were masked to treatment assignment. The primary safety outcome was dose-limiting toxicity effects. The primary efficacy endpoint was global stroke recovery, which combines dichotomised results from the modified Rankin scale, change in NIHSS score from baseline, and Barthel index at day 90. Analysis was by intention to treat (ITT) including all patients in groups 2 and 3 who received the investigational agent or placebo. This study is registered with ClinicalTrials.gov, number NCT01436487. Findings The study was done between Oct 24, 2011, and Dec 7, 2015. After safety assessments in eight patients in group 1, 129 patients were randomly assigned (67 to receive multipotent adult progenitor cells and 62 to receive placebo) in groups 2 and 3 (1200 million cells). The ITT populations consisted of 65 patients who received multipotent adult progenitor cells and 61 patients who received placebo. There were no dose-limiting toxicity events in either group. There were no infusional or allergic reactions and no difference in treatment-emergent adverse events between the groups (64 [99%] of 65 patients in the multipotent adult progenitor cell group vs 59 [97%] of 61 in the placebo group). There was no difference between the multipotent adult progenitor cell group and placebo groups in global stroke recovery at day 90 (odds ratio 1·08 [95% CI 0·55–2·09], p=0·83). Interpretation Administration of multipotent adult progenitor cells was safe and well tolerated in patients with acute ischaemic stroke. Although no significant improvement was observed at 90 days in neurological outcomes with multipotent adult progenitor cells treatment, further clinical trials evaluating the efficacy of the intervention in an earlier time window after stroke (<36 h) are planned. Funding Athersys Inc.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
mengliu完成签到,获得积分10
2秒前
李健的粉丝团团长应助Li采纳,获得10
5秒前
NexusExplorer应助zhouleiwang采纳,获得10
8秒前
云上人完成签到 ,获得积分10
9秒前
wxh发布了新的文献求助10
10秒前
suxili完成签到 ,获得积分10
12秒前
13秒前
大观天下发布了新的文献求助10
16秒前
熊二浪完成签到,获得积分10
18秒前
Owen应助读书的时候采纳,获得10
20秒前
大模型应助wxh采纳,获得10
20秒前
22秒前
威武灵阳完成签到,获得积分10
23秒前
sunnn完成签到 ,获得积分10
23秒前
薯条一克完成签到 ,获得积分10
26秒前
郗妫完成签到,获得积分10
27秒前
深山何处钟声鸣完成签到 ,获得积分0
28秒前
欢呼的世立完成签到 ,获得积分10
28秒前
平常的羊完成签到 ,获得积分10
35秒前
未夕晴完成签到,获得积分10
37秒前
Atropine完成签到 ,获得积分10
40秒前
41秒前
41秒前
42秒前
明亮访烟完成签到 ,获得积分10
44秒前
zhouleiwang发布了新的文献求助10
45秒前
46秒前
荔枝完成签到 ,获得积分10
46秒前
忐忑的雪糕完成签到 ,获得积分10
48秒前
Cong发布了新的文献求助10
49秒前
SYLH应助小刘采纳,获得10
51秒前
jojo完成签到 ,获得积分10
54秒前
55秒前
广东第一深情完成签到,获得积分10
58秒前
灵巧的十八完成签到 ,获得积分10
59秒前
wxh发布了新的文献求助10
1分钟前
桐桐应助zhouleiwang采纳,获得10
1分钟前
啊哈哈哈完成签到 ,获得积分10
1分钟前
小湛完成签到 ,获得积分10
1分钟前
菜根谭完成签到 ,获得积分10
1分钟前
高分求助中
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989989
求助须知:如何正确求助?哪些是违规求助? 3532034
关于积分的说明 11256053
捐赠科研通 3270900
什么是DOI,文献DOI怎么找? 1805105
邀请新用户注册赠送积分活动 882270
科研通“疑难数据库(出版商)”最低求助积分说明 809216