drugset / Trial / NCT02543073
MSC for Treatment of Interstitial Lung Disease After Allo-HSCT
Phase 1/2
Unknown
60 enrolled
Nanfang Hospital, Southern Medical University
Sun Yat-sen University · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2014-09
- Primary completion
- 2017-12
- Completion
- 2018-06
Outcome
Met primary endpoint
paper Response rate was 35/49 patients (71%, 95% CI 59 to 84%) and 14/32 (44%, 27 to 61%) in MSC and non-MSC group, respectively (p = 0.013). PMID 31668569 ↗
Publications
- Background Olivieri A, Locatelli F, Zecca M, Sanna A, Cimminiello M, Raimondi R, Gini G, Mordini N, Balduzzi A, Leoni P, Gabrielli A, Bacigalupo A. Imatinib for refractory chronic graft-versus-host disease with fibrotic features. Blood. 2009 Jul 16;114(3):709-18. doi: 10.1182/blood-2009-02-204156. Epub 2009 Apr 29.
- Chen S, Zhao K, Lin R, Wang S, Fan Z, Huang F, Chen X, Nie D, Du X, Guo Z, Lin D, Xuan L, Xu N, Sun J, Peng Xiang A, Liu Q. The efficacy of mesenchymal stem cells in bronchiolitis obliterans syndrome after allogeneic HSCT: A multicenter prospective cohort study. EBioMedicine. 2019 Nov;49:213-222. doi: 10.1016/j.ebiom.2019.09.039. Epub 2019 Oct 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MSCs | Cell therapy | 1e+06 cells/kg | — |
| Background | AZM | Unknown | 0.25 g | — |
| Background | Prednisone | Other / unclassified | 1 mg/kg | — |