NCT01895439已完成1 期
Phase II Study: Use of Autologus Mesenchymal Stem Cells in Multiple Sclerosis Patients Who do Not Respond to Conventional Treatment
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- The number of patients with any relevant side effects observed
研究概览
简要总结
- Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice using xenogenic free media instead of the previously used FCS.
- Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients who fail to respond to conventional treatment.
- Assessing the therapeutic benefits on the participants in the trial as per established methods.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of definite MS according to the revised McDonald Criteria.
- •Expanded Disability Status Scale (EDSS) ≤ 6
- •Failure of standard medical therapy
- •Disease duration of at least three years prior to enrollment.
排除标准
- •Pregnant and lactating women
- •Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment
- •Recent MS relapse in the month prior to enrollment
- •Treatment with oral or parenteral steroids for any cause in the month prior to enrollment
- •Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders
- •Previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment
- •Any contra-indication for magnetic resonance imaging (MRI) or gadolinium contrast.
- •Positive serology for HIV, Hepatitis B or Hepatitis C
- •Any history of malignancy or exposure to radiation at any time prior to enrollment
- •Any contra-indication to lumbar puncture
- •Severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.
结局指标
主要结局
The number of patients with any relevant side effects observed
时间窗: 18 months
Assessing the safety of autologous Mesenchymal Stem Cells injection
次要结局
- Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Magnetic Resonance Imaging (MRI) and ophthalmological tests.(18 months)
研究者
Fatima Jamali
Researcher
University of Jordan
研究点 (2)
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