NCT03929120已完成1 期
A Phase I Study to Evaluate the Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for Interstitial Lung Disease in Patients With Connective Tissue Disorders
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
Researchers are trying to find out more about the safety of a new treatment, Allogeneic (coming from a healthy donor) Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs) which is still experimental, for Interstitial Lung Disease (ILD) associated with Connective Tissue Disorder (CTD).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 18 years of age and less than 80 years of age
- •Both female and male
- •Patients with new diagnosis of interstitial lung disease associated with connective tissue disorders, Antineutrophil cytoplasmic antibodies (ANCA) associated vasculitis or idiopathic pneumonia with autoimmune features (IPAF) or established diagnosis of ILD associated with CTD under conventional therapy for at least 6 months but less than 24 months, with no evidence of improvement.
- •Competent and able to provide written informed consent, and ability to comply with protocol
排除标准
- •Patients with interstitial lung disease without evidence of a concomitant rheumatologic autoimmune disorder
- •Exposure to rituximab or cyclophosphamide on the previous 2 months
- •Severe interstitial lung disease defined by the presence of severe hypoxemia at rest (SO2 < 88% at rest)
- •Clinical assessment that indicates active chronic infections such as osteomyelitis or active tuberculosis (TB), or acute infections such as pneumonia, active bronchitis, cellulitis, etc. or active solid tumors or hematologic malignancies
- •Previous treatment with mesenchymal stem cells
- •Clinically significant medical conditions within the six months before administration of BMD-MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
- •Medical history of human immunodeficiency virus (HIV), Hepatitis B or C
- •Abnormal complete blood count (CBC), creatinine, Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) at screening
- •Pregnant or breast feeding
- •Unwilling to agree to use acceptable contraception methods during participation in the trial
- •Inability to provide informed consent
结局指标
主要结局
Adverse Events
时间窗: 6 months
Number of adverse events reported with infusion of each intravenous Mesenchymal Stem Cells (MSC) dose
次要结局
未报告次要终点
研究者
Andy Abril, M.D.
Principal Investigator
Mayo Clinic
研究点 (2)
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