A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of Subcutaneous Administration of Umbilical Cord Derived - Mesenchymal Stromal Cell Therapy in Addition to Standard of Care as A Treatment For Active Systemic Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and effectiveness of UC-MSCs in adults with systemic lupus erythematosus (SLE).
The main questions this study aims to answer are:
- Can UC-MSCs improve kidney function and reduce SLE disease activity?
- Are UC-MSCs safe and well-tolerated in this patient population?
Participants in this study will:
- Receive UC-MSCs in a single dose in addition to standard of care treatment.
- Provide blood and urine samples for laboratory assessments, including biomarkers and immune profiling (e.g., cytokines, complement proteins, and autoantibodies).
- Attend regular clinic visits for physical exams, disease activity scoring, and imaging tests to monitor kidney health.
- Complete assessments for safety, such as monitoring for adverse events and changes in laboratory values.
This study aims to provide new insights into treatment options for SLE and lupus nephritis, addressing an unmet medical need in this population.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
UC-MSC therapy
干预措施: Physical examination (Diagnostic Test)
UC-MSC therapy
干预措施: Electrocardiogram (Diagnostic Test)
UC-MSC therapy
干预措施: SF-36 questionnaire (Other)
UC-MSC therapy
干预措施: Clinical laboratory evaluations - Serology (Diagnostic Test)
UC-MSC therapy
干预措施: Clinical laboratory evaluations - Biochemistry (Diagnostic Test)
UC-MSC therapy
干预措施: Clinical laboratory evaluations - Hematology (Diagnostic Test)
UC-MSC therapy
干预措施: Pregnancy Test (Diagnostic Test)
UC-MSC therapy
干预措施: Urinalysis (Diagnostic Test)
UC-MSC therapy
干预措施: SLE activity evaluation (Diagnostic Test)
UC-MSC therapy
干预措施: SLE biomarker profiling (Diagnostic Test)
UC-MSC therapy
干预措施: Cytokines and chemokine profiling (Diagnostic Test)
UC-MSC therapy
干预措施: single dose of UC-MSCs (Biological)
UC-MSC therapy
干预措施: PROMIS instruments (Other)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: day 1 to day 168
Analysis for the primary endpoint will be descriptive in nature. safety and tolerability will be measured by the number of AEs and SAEs observed. Adverse event incidents will be summarized descriptively. The severity grade of each recorded AE, and their relationship to study treatment will be analyzed. The action taken and outcome will also be analyzed accordingly.
次要结局
- Change from baseline in the SLEDAI 2K following administration(day 1 to day 168)
- Change from baseline in PROMIS(Patient-Reported Outcomes Measurement Information System) score(day 1 to day 168)
- Change from baseline in the BILAG-2004 Index score following administration(day 1 to day 168)
- Efficacy by SRI-4 Responder assessment at Day 168.(day 1 to day 168)
- Change from baseline in prednisone-equivalent corticosteroid doses at each visit performed.(day 1 to day 168.)