Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear Cells (ETIMS)
2015年4月8日 更新者：Universitätsklinikum Hamburg-Eppendorf
Establish Tolerance in Multiple Sclerosis With Peptide-coupled, Peripheral Blood Mononuclear Cells - A MRI-controlled, Single Center, Phase I Trial in Relapsing-remitting MS Patients
Open-label, single center, phase I clinical trial to assess the safety, tolerability and preliminary efficacy and in vivo mechanisms of action of i.v.
administration of autologous peripheral blood mononuclear cell (PBMC) chemically coupled with a cocktail containing seven immunodominant myelin peptides to which T cell responses are demonstrable in early RR MS patients.
研究概览
详细说明
Open-label, single center, phase I dose-escalation study to assess the safety, tolerability and preliminary efficacy and in vivo mechanisms of action of a single infusion of autologous peripheral blood mononuclear cells chemically coupled with seven myelin peptides (MOG1-20, MOG35-55, MBP13-32, MBP83-99, MBP111-129, MBP146-170, and PLP139-154) in Multiple Sclerosis patients who were off-treatment for standard therapies.
Neurological, magnetic resonance imaging, laboratory, and immunological examinations were performed to assess the safety, tolerability, and in vivo mechanisms of action of this regimen.
研究类型
介入性
注册 (实际的)
9
阶段
- 阶段2
- 阶段1
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 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Between the ages of 18 and 55 years.
- Patients with relapsing-remitting (Phase I/II) or secondary progressive MS (Phase I) according to published criteria
- EDSS score between 1 and 5.5.
- Patients are off-treatment for standard therapies (interferon-beta, glatiramer acetate, natalizumab, mitoxantrone)
- Patients are able to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care.
- Disease duration ≤ 5 years (Only Phase II)
Exclusion Criteria:
- Diagnosis of secondary-progressive (Phase II) or primary-progressive MS, as defined by published diagnostic criteria.
- Abnormal screening/baseline blood tests exceeding any of the limits defined
- Pregnant or breast-feeding female.
- History or signs of immunodeficiency.
- Concurrent clinically significant (as determined by the investigators) cardiac, immunological, pulmonary, neurological, renal or other major disease.
- Splenectomy
- History of HIV or positive HIV antibody testing
- Serology indicating active Hepatitis B or C infection.
- Patients with cognitive impairments who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care
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：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ETIMS 1x10^3
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 1x10^3 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
实验性的：ETIMS 1x10^5
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 1x10^5 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
实验性的：ETIMS 1x10^7
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 1x10^7 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
实验性的：ETIMS 1x10^8
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 1x10^8 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
实验性的：ETIMS 5x10^8
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 5x10^8 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
实验性的：ETIMS 1x10^9
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 1x10^9 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
实验性的：ETIMS 2.5x10^9
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 2.5x10^9 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
|
实验性的：ETIMS 3x10^9
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma.
This patient receives 3x10^9 cells.
|
injection of peptide-coupled PBMC by i.v.
infusion
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
大体时间：12 months
|
12 months
|
|
Number of Adverse Events
大体时间：3 months after treatment
|
3 months after treatment
|
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：Christoph Heesen, MD、Department of Neurology, University Clinic Eppendorf (UKE)
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。
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
2010年2月1日
初级完成 (实际的)
2012年10月1日
研究完成 (实际的)
2012年10月1日
研究注册日期
首次提交
2011年8月8日
首先提交符合 QC 标准的
2011年8月10日
首次发布 (估计)
2011年8月11日
研究记录更新
最后更新发布 (估计)
2015年5月4日
上次提交的符合 QC 标准的更新
2015年4月8日
最后验证
2015年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- inims-oo1
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