Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- To evaluate number of participants with an adverse event related to the treatment.
研究概览
简要总结
To assess the safety of a single dose of IV infusion of bone-marrow derived autologous Mesenchymal Stem Cells (MSCs) in Multiple Sclerosis (MS) with progressive disease status.
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
- •Diagnosis of MS
- •Active relapsing remitting MS (RRMS) as evidenced by presence of ≥ 1 clinically documented relapse in the past 12 months or ≥2 clinically documented relapses in the last 24 months.
- •Secondary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year or evidenced by ≥1 relapse or ≥ GEL at MRI performed within the last year.
- •Primary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year.
- •Age_ 18-65 years
- •Disease duration: 2-20 years
- •EDSS 3,0-7,0
排除标准
- •Subtype of MS not fulfilling inclusion criteria
- •Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
- •Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
- •Treatment with corticosteroids within the 30 days prior to randomization
- •Relapse occurred during the 60 days prior to randomization
- •Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year
- •Severely limited life expectancy by another co-morbid illness
- •Active or chronic severe infection.
- •History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts
- •Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)
- •eGFR < 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.
- •Inability to give written informed consent in accordance with research ethics board guidelines
研究组 & 干预措施
Open label single arm study
All patients will be treated with 1 single dose of IV infusion of autologous bone-marrow derived mesenchymal stem cells (1-2 million cells/kg body weight) and their therapeutic response will be followed over 48 weeks.
干预措施: Autologous mesenchymal stem cells (Biological)
结局指标
主要结局
To evaluate number of participants with an adverse event related to the treatment.
时间窗: 48 weeks
Adverse events is defined as any untoward or undesirable medical occurence in the form of signs, symptoms, abnormal findings or diseases that emerge during the study period, regardless of causal relationship to the study drug.
To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions.
时间窗: 48 weeks
Brain MRI examination
次要结局
- To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).(48 weeks)
- To evaluate effect on peripheral blood immune cell populations.(24 weeks)
研究者
Lou Brundin
MD, PhD
Karolinska Institutet