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
干预措施
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
- 1
- 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
研究组 & 干预措施
Interstitial Lung Disease with Connective Tissue Disorder
Experimental
Subjects with Interstitial Lung Disease (ILD) associated with Connective Tissue Disorder (CTD) will receive a new treatment called Allogeneic (coming from a healthy donor) Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs)
干预措施: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs) (Biological)
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 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™Malaria,FalciparumNCT06320535University of Oxford36
已完成
1 期
Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid TumorAdvanced Solid TumorNCT03239145Dana-Farber Cancer Institute62
已完成
1 期
A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy PeopleCardiometabolic DiseasesHealthy VolunteersNCT06336005Novo Nordisk A/S56
招募中
早期 1 期
Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic LeukemiaB-Cell Acute Lymphoblastic Leukemia, AdultNCT06696833The First Affiliated Hospital of Soochow University18
Unknown
1 期
A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of PatientsAdvanced Malignant TumorsNCT05198817Suzhou Suncadia Biopharmaceuticals Co., Ltd.240