Allogeneic Mesenchymal Stem Cell-Derived Exosome Therapy for Progressive Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Expanded Disability Status Scale (EDSS) score
研究概览
简要总结
The goal of this clinical trial is to learn if intravenous infusion of allogeneic mesenchymal stem cell (MSC)-derived exosomes can slow disability progression and improve neurological function in adults with progressive multiple sclerosis (MS). The trial will also evaluate the safety and tolerability of repeated exosome infusions.
The main questions it aims to answer are:
Does MSC-derived exosome therapy reduce disability progression as measured by the Expanded Disability Status Scale (EDSS)?
Does MSC-derived exosome therapy decrease neuroinflammation and brain lesion burden compared with placebo?
Researchers will compare participants who receive MSC-derived exosome therapy to those who receive placebo (saline infusion) to see if the treatment improves clinical and biological outcomes.
Participants will:
Receive either MSC-derived exosome infusions or placebo infusions every 3 months for 1 year (4 total infusions)
Undergo clinical assessments (neurological exams, EDSS scoring, neurocognitive testing)
Provide blood and cerebrospinal fluid samples for biomarker analysis
Have MRI scans to evaluate lesion load and brain volume
Complete questionnaires on quality of life and daily functioning
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Age 18-65 years.
- •Diagnosis of progressive multiple sclerosis (primary or secondary) confirmed
- •EDSS score 3.0-6.5.
排除标准
- •Relapse or corticosteroid treatment within 3 months before screening.
- •Other significant neurological or autoimmune disorders.
- •Active infection, malignancy, or uncontrolled systemic disease.
研究组 & 干预措施
MSC-Derived Exosomes
Participants receive intravenous infusions of allogeneic mesenchymal stem cell (MSC)-derived exosomes every 12 weeks for 48 weeks (total of 4 infusions) in addition to their stable background MS therapy (if any).
干预措施: MSC-Derived Exosomes (Biological)
Normal Saline
Participants receive intravenous infusions of 0.9% sodium chloride (saline) matched in volume, appearance, and schedule to the experimental arm, in addition to their stable background MS therapy (if any).
干预措施: Placebo (Normal Saline) (Biological)
结局指标
主要结局
Change in Expanded Disability Status Scale (EDSS) score
时间窗: 24 months from the day of administration
Unit of measure: points (range: 0-10; higher scores indicate worse disability).
次要结局
- Change in neurocognitive performance(24 months after first administration)
- Change in T2 lesion load and brain atrophy(24 months after the first administration)
研究者
Andrei Peskau
Specialist in regenerative medicine
Biocells Medical