同种异体人类细胞 (hMSC) 通过轻度哮喘患者的静脉给药 (ASTEC)
2020年5月20日 更新者：Marilyn Glassberg
评估同种异体人间充质干细胞输注对轻度哮喘患者的安全性、耐受性和潜在疗效的 I 期试验
将进行第 1 阶段调查，以测试通过外周静脉输注给药的两剂骨髓来源的 MSC（20,000,000 和 100,000,000）的安全性。
研究概览
详细说明
将进行第 1 阶段调查，以测试通过外周静脉输注给药的两剂骨髓来源的 MSC（20,000,000 和 100,000,000）的安全性。
第 1 组：3 名受试者将接受单次同种异体 hMSC 给药：2000 万个细胞通过外周静脉输注递送 第 2 组：3 名受试者将接受单次同种异体 hMSC 给药：1 亿个细胞通过外周静脉输注递送 将进行中期安全性分析第一个受试者被纳入每个队列后的四个星期。 每次就诊时将评估不良事件 (AE) 的持续安全性和耐受性。 将每 12 周评估一次疗效参数（肺功能测试、弥散量 (DLCO)、肺容量、6 分钟步行测试 (6MWT) 和呼吸困难/生活质量 [QOL] 问卷），直至研究完成。 每次就诊时都会进行临床实验室测试以评估安全性。
研究类型
介入性
注册 (实际的)
3
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Florida
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Miami、Florida、美国、33125
- University of Miami Miller School of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 提供书面知情同意书
- 签署知情同意书时年龄在 18 至 65 岁之间
- 根据美国胸科学会/欧洲呼吸学会的指南，在筛查前有哮喘的临床诊断
- ACQ 超过 1.25
- 吸烟史总计少于 10 包年，并且至少在过去 12 个月内没有吸烟
- 在筛选时进行阳性乙酰甲胆碱激发，并在基线访视时重复阳性乙酰甲胆碱激发（14 天后）
- 进行正常或轻度阻塞性肺活量测定
- 多普勒超声或右心导管插入术证明右心功能正常
- 如果是女性，则进行手术绝育、绝经后（超过 1 年）或采用双重屏障避孕方法
- 受试者可能会接受非药物治疗，包括不超过 2 升/分钟的氧气补充和肺康复
- 受试者可能正在接受标准的哮喘治疗药物治疗，包括剂量不超过 1 mg 氟替卡松当量的吸入皮质类固醇-长效 β 激动剂
排除标准：
- 有任何未治疗的活动性感染
- 无法执行终点分析所需的任何评估。
- 目前正在接受（或在筛选后 4 周内接受过）治疗哮喘的实验药物
- 正在积极上市（或预期在不久的将来上市）用于任何器官的移植
- 具有临床重要的异常筛查实验室值：血液筛查测试（血液学、化学、CBC，包括嗜酸性粒细胞计数）结果不在正常范围内（根据 UMHC 实验室参考范围） 有严重的合并症，研究者认为，可能会危及患者的安全或依从性或妨碍成功完成研究
- 已知对青霉素或链霉素过敏
- 成为器官移植受者
- 有 5 年内恶性肿瘤的临床病史（即既往有恶性肿瘤的患者必须 5 年无病），已治愈的基底细胞癌除外
- 患有非肺部疾病，将寿命限制在不到一年。
- 在过去 24 个月内有吸毒或酗酒史。
- HIV、肝炎 BsAg 或丙型肝炎病毒血症血清呈阳性
- 目前正在参与（或在过去 30 天内参与过）研究性治疗或设备试验。
- 对二甲亚砜 (DMSO) 过敏
- 室内空气的静息氧饱和度 (SpO2) 在海平面超过 93%，或在海拔 5,000 英尺（1524 米）以上的高度超过 88%
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：接收2000万个hMSC的组
3 名患者将接受同种异体 hMSC 的单次给药：20 x106（2000 万）个细胞通过外周静脉输注递送
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静脉输注骨髓来源的同种异体干细胞
其他名称：
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实验性的：1亿个hMSC接收组
3 名患者将接受同种异体 hMSC 的单次给药：1 x108（1 亿）个细胞通过外周静脉输注递送
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静脉输注骨髓来源的同种异体干细胞
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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发生治疗紧急严重不良事件的参与者人数
大体时间：输注后第 4 周
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定义为任何治疗中出现的严重不良事件的发生率；这些是死亡、非致命性肺栓塞、中风、因呼吸困难恶化住院和有临床意义的实验室检查异常的综合结果
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输注后第 4 周
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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肺功能差异
大体时间：参与者将在输注后 1 周至预计平均 48 周内接受随访
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FEV1 早晨峰值呼气流量测量值变异性的差异 急性加重频率的差异定义为： 住院、误工和/或口服类固醇超过 3 天 吸入 NO（FENO；小于 50 ppb）的部分排泄减少 |
参与者将在输注后 1 周至预计平均 48 周内接受随访
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外周嗜酸性粒细胞增多减少
大体时间：参与者将在输注后 1 周至预计平均 48 周内接受随访
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外周嗜酸性粒细胞数量减少
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参与者将在输注后 1 周至预计平均 48 周内接受随访
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受试者报告的呼吸困难和生活质量评估的差异
大体时间：参与者将在输注后 1 周至预计平均 48 周内接受随访
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受试者报告的呼吸困难和生活质量评估的差异： 哮喘控制测试 (ACT) 和哮喘控制问卷 (ACQ) |
参与者将在输注后 1 周至预计平均 48 周内接受随访
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因任何原因死亡
大体时间：参与者将在输注后 1 周至预计平均 48 周内接受随访
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因任何原因死亡
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参与者将在输注后 1 周至预计平均 48 周内接受随访
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Marilyn K Glassberg, MD、University of Miami
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年6月22日
初级完成 (实际的)
2020年3月3日
研究完成 (实际的)
2020年4月29日
研究注册日期
首次提交
2017年4月24日
首先提交符合 QC 标准的
2017年4月29日
首次发布 (实际的)
2017年5月2日
研究记录更新
最后更新发布 (实际的)
2020年5月21日
上次提交的符合 QC 标准的更新
2020年5月20日
最后验证
2020年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.