Mesenchymal Stem Cell for Treatment of Interstitial Lung Disease After Allogenetic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Response rate of ILD
研究概览
简要总结
Interstitial lung disease (ILD） is the late pulmonary complications after allogeneic hematopoietic stem cell transplantation (allo-HSCT) leading to high morbidity and mortality. At present, the treatment for ILD after allo-HSCT remains in discussion. In this study, the efficacy of mesenchymal stem cells (MSCs) combined azithromycin as well as glucocorticoid as the treatment of ILD will be evaluated in the recipients of allo-HSCT.
详细描述
ILD is a group of diseases involving pulmonary interstitial, alveolar and (or) bronchioles. In the patients receiving allo-HSCT, ILD mainly present as bronchiolitis obliterans syndrome (BOS). ILD after HSCT is characterized by non-responsiveness to treatment, leading to high morbidity and mortality. MSC has been considered as an effective treatment for refractory acute graft-versus-host disease (aGVHD), but the response to treat chronic GVHD (cGVHD), especially refractory BOS, is rarely reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving allo-HSCT
- •Diagnosed with ILD after allo-HSCT
排除标准
- •Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- •Patients with any conditions not suitable for the trial (investigators' decision)
研究组 & 干预措施
MSCs
MSCs will be given the patients in MSCs group. Besides, azithromycin (AZM) and glucocorticoid will also be administered.
干预措施: Glucocorticoid (Drug)
MSCs
MSCs will be given the patients in MSCs group. Besides, azithromycin (AZM) and glucocorticoid will also be administered.
干预措施: MSCs (Biological)
MSCs
MSCs will be given the patients in MSCs group. Besides, azithromycin (AZM) and glucocorticoid will also be administered.
干预措施: AZM (Drug)
Non-MSCs
AZM and glucocorticoid will be given for the patients in Non-MSCs group.
干预措施: AZM (Drug)
Non-MSCs
AZM and glucocorticoid will be given for the patients in Non-MSCs group.
干预措施: Glucocorticoid (Drug)
结局指标
主要结局
Response rate of ILD
时间窗: 4 weeks
Response includes complete response (CR) and partial response (PR). CR is defined as resolution of all manifestations related to ILD, except for some irreversible changes. PR is defined as sustained, measurable improvement in pulmonary function tests(carbon monoxide lung diffusion capacity, forced expiratory volume, or both) or the ability to reduce corticosteroids by at least 50% or both without deterioration of pulmonary function.
次要结局
- Overall Survival(3 year)
研究者
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University