NCT01175655已完成1 期
A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- To establish the safety of infusions of MSC from related or unrelated HLA identical or HLA mismatched donors in the management of bronchiolitis obliterans syndrome after lung transplantation.
研究概览
简要总结
The primary aim of this study is to establish the safety of infusions of Mesenchymal Stromal Cells (MSC) from related or unrelated Human Leukocyte Antigen (HLA) identical or HLA mismatched donors in the management of bronchiolitis obliterans syndrome after lung transplantation.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with single, bilateral or heart-lung allografts
- •Patients with bronchiolitis obliterans syndrome (BOS) grades 2 & 3 (defined and graded according to international criteria (Appendix 1)), with evidence of deterioration in allograft function (i.e. deteriorating FEV1 or worsening BOS grade) within the last 12 months.
- •Patients with BOS grade 1 and evidence of deterioration in allograft function (i.e. deteriorating FEV1 or worsening BOS grade) within the last 12 months and at least one of the following additional risk factors for subsequent death:
- •Single lung transplant
- •Rapid deterioration (>20% fall in FEV1 in the previous 12 months)
- •A pre-transplant diagnosis of usual interstitial pneumonia (pulmonary fibrosis) or pulmonary hypertension
排除标准
- •Patients with active infection, acute allograft rejection, or airway anastomotic complications
- •Patients with > 3 infective exacerbations of BOS in the last 12 months
- •Patients with a history of cytomegalovirus (CMV) pneumonitis
- •Patients with poor performance status and/or not expected to survive 3 months
- •Patients who are pregnant or breastfeeding
- •Patients with an allergy to beef products.
- •Any condition that in the opinion of the Investigator may interfere with the safety of the patient, his / her completion of required follow-up visits or evaluation of the study objectives.
研究组 & 干预措施
MSC
Experimental
干预措施: MSC (Other)
结局指标
主要结局
To establish the safety of infusions of MSC from related or unrelated HLA identical or HLA mismatched donors in the management of bronchiolitis obliterans syndrome after lung transplantation.
时间窗: 12 months
次要结局
- To document changes in lung function and 6 minute walk distance (6MWD) following infusion of MSC(12 months)
- To document survival post MSC infusion(12 months)
研究者
Daniel Chambers
Principal Investigator
The Prince Charles Hospital
研究点 (2)
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