A Phase 1/2 interventional study of MSCs and AZM in Lung Diseases, Interstitial, Hematopoietic Stem Cell Transplantation and Bronchiolitis Obliterans, sponsored by Nanfang Hospital, Southern Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-05-10.
Sponsored by Nanfang Hospital, Southern Medical University · Phase 1/2, Interventional, and Treatment
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.
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.
360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 249 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MSCs will be given the patients in MSCs group. Besides, azithromycin (AZM) and glucocorticoid will also be administered.
Biological: MSCs · Drug: AZM · Drug: Glucocorticoid
AZM and glucocorticoid will be given for the patients in Non-MSCs group.
Drug: AZM · Drug: Glucocorticoid
MSCs will be given at a median dose of 1×10\^6 cells/kg once weekly for 4 weeks as one cycle treatment.
AZM will be given （0.25g qd）for 4 weeks as one cycle treatment.
Glucocorticoid (prednison) will be given at the starting dose of 1mg/kg for 4 weeks as one cycle treatment.
Response rate of ILD
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.
Time frame: 4 weeks
Overall Survival
The 3-year overall survival after HSCT will be evaluated
Time frame: 3 year
This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nanfang Hospital, Southern Medical University