Monitoring of Outcomes of Cellular and Exosome-based Therapies in Autoinflammatory and Post-infectious Neuroinflammatory Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in neurological symptom severity
研究概览
简要总结
This is a prospective, non-randomized, observational registry study evaluating the clinical outcomes of patients with autoimmune or post-infectious neuroinflammatory syndromes receiving stem cell-derived biologics (including mesenchymal stem cells and exosomes) at Biocells Medical clinics. The study aims to track improvements in neurological function, inflammatory biomarkers, and patient-reported quality of life following individualized regenerative interventions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age 6-70
- •Diagnosis of one of the eligible syndromes by neurologist or immunologist
- •Unresponsive or partially responsive to conventional therapy
- •Informed consent provided
排除标准
- •• Active malignancy
- •Severe systemic infection
- •Contraindications to IV biologics
研究组 & 干预措施
B1
- Age 6-70
- Diagnosis of one of the eligible syndromes by neurologist or immunologist
- Unresponsive or partially responsive to conventional therapy
- Informed consent provided
干预措施: Allogeneic MSC infusions (IV) (Biological)
结局指标
主要结局
Change in neurological symptom severity
时间窗: from enrollment to the end of treatment at 8 weeks
Change in neurological symptom severity as measured by the National Institutes of Health Stroke Scale (NIHSS; range 0-42, higher scores indicate greater severity)
次要结局
- Change in serum cytokine levels(From the enrolment till the end of the treatment (8 weeks))
- Change in patient-reported quality of life(From the enrolment till the end of the treatment (8 weeks))