An Open-label, Non-randomized, Phase I Study of Allogeneic Placenta Derived Mesenchymal Stem Cells in Patients With Secondary-Progressive Multiple Sclerosis (SPMS),
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability].
研究概览
简要总结
To assess the safety and of a single dose of IV infusion of placenta derived Mesenchymal Stem Cells (PLMSCs) in patients with secondary progressive Multiple Sclerosis (SPMS) disease.
Monitoring will be encompassed baseline assessments and follow-ups over subsequent months, evaluating clinical signs, Expanded Disability Status Scale (EDSS), cytokines, diffusion tensor imaging (DTI), functional MRI (fMRI), cognitive & psychological evaluations, and flow cytometry for B cell markers.
详细描述
This open-label phase I study will be conducted in MS Clinic of Sina and Shariati Hospital of Tehran province .
In this study, diagnosis and management of MS patients will be performed based on McDonald's criteria and Iran's diagnostic and treatment protocols.
The patients will be received a single injection of PLMSCs through the intravenous cannula.
The proposed study will assess safety and short efficacy endpoints of PLMSCs administered to 5 patients with SPMS.
The primary objective of the trial is freedom from treatment associated adverse events at 1,3 and 6 months' post treatment. Secondary objective will be efficacy as assessed at baseline, at 1,3 and 6 months and will be based on the following: EDSS, cytokines, DTI, fMRI, cognitive & psychological evaluations, and flow cytometry for B cell markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 17-45 years Patients with SPMS .
- •Must be able to Sign informed consent .
- •Currently taking Rituximab.
- •Disease duration of more than 2 and less than 16 years.
排除标准
- •Pregnancy or breastfeeding.
- •hepatitis B and C, human immunodeficiency virus (HIV), and human T-cell lymphotropic virus (HTLV) disease.
- •Using cytotoxic agents within 3 months prior to the study.
- •Severe anemia (hemoglobin< 8 mg/dl), coagulation disorders.
- •history of malignancy .
- •liver disorders .
- •significant cardiac, renal or hepatic failure .
- •Active or chronic infection.
- •Life-threatening organ dysfunction.
- •Unable to give written informed consent .
- •Current treatment with an investigational therapy.
结局指标
主要结局
Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability].
时间窗: Up to 6 months
adverse events
次要结局
- Number of participants with a change in brain connectivity as measured by Functional magnetic resonance imaging .(Up to 6 months)
- Number of participants with a change in cognitive performance as measured by Persian version of minimal assessment of cognitive function in MS battery.(Up to 6 months)
- Proportion of patients with change in CD20 / CD19 B cells surface markers(Up to 3 months)
- Proportion of patients for psychological assessment as measured by the validated Persian version of Symptom Checklist-90-Revised .(Up to 6 months)
- Number of participants with a change in white matter integrity as measured by quantitative diffusion tensor imaging .(Up to 6 months)
- Proportion of patients with change in brain volume on MRI.(Up to 6 months)
- Proportion of patients for assessment of visuospatial ability as measured by the California Verbal Learning Test Second Edition test.(Up to 6 months)
- Biological Assessments including IL-10, IL-6, IL-17, and TNFα levels of cytokines.(Up to 3 months)
- Proportion of patients with change in T2 lesion volume on brain MRI.(Up to 6 months)
- Proportion of patients for assessment of visuospatial ability as measured by Judgment of Line Orientation Test .(Up to 6 months)
- Proportion of patients for measuring verbal fluency as measured by the Controlled Oral Word Association Test .(Up to 6 months)
- Proportion of patients for assessment of visuospatial ability as measured by the brief visuospatial memory test-revised test.(Up to 6 months)
- Number of participants with a change in disability as measured by Expanded Disability Status Scale .(Up to 6 months)
- Number of participants with a change in cognitive function as measured by the Paced Auditory Serial Addition Test .(Up to 6 months)
- Number of participants with evaluation of verbal learning and memory deficits as measured by the California Verbal Learning Test second edition .(Up to 6 months)
- Proportion of patients for evaluation of executive functions as measured by the Delis-Kaplan Executive Function System Sorting and descriptive tests.(Up to 6 months)
- Number of participants with a change in processing and motor speed as assessed by the Symbol Digit Modalities Test .(Up to 6 months)
- Proportion of patients for assessment of visuospatial learning as measured by the Brief Visuospatial Memory Test-Revised .(Up to 6 months)
- Proportion of patients for evaluation of fatigue as measured by was examined by the Persian version of Fatigue Severity Scale .(Up to 6 months)