Trials / Unknown
UnknownNCT02543073
MSC for Treatment of Interstitial Lung Disease After Allo-HSCT
Mesenchymal Stem Cell for Treatment of Interstitial Lung Disease After Allogenetic Hematopoietic Stem Cell Transplantation
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Nanfang Hospital, Southern Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MSCs | MSCs will be given at a median dose of 1×10\^6 cells/kg once weekly for 4 weeks as one cycle treatment. |
| DRUG | AZM | AZM will be given （0.25g qd）for 4 weeks as one cycle treatment. |
| DRUG | Glucocorticoid | Glucocorticoid (prednison) will be given at the starting dose of 1mg/kg for 4 weeks as one cycle treatment. |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2017-12-01
- Completion
- 2018-06-01
- First posted
- 2015-09-07
- Last updated
- 2017-05-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02543073. Inclusion in this directory is not an endorsement.