Lung Diseases, Interstitial, Hematopoietic Stem Cell Transplantation, Bronchiolitis Obliterans
Conditions
Brief 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.
Interventions
BIOLOGICALMSCs
MSCs will be given at a median dose of 1×10\^6 cells/kg once weekly for 4 weeks as one cycle treatment.
DRUGAZM
AZM will be given （0.25g qd）for 4 weeks as one cycle treatment.
DRUGGlucocorticoid
Glucocorticoid (prednison) will be given at the starting dose of 1mg/kg for 4 weeks as one cycle treatment.
Sponsors
Sun Yat-sen University
Nanfang Hospital, Southern Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Receiving allo-HSCT * Diagnosed with ILD after allo-HSCT
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate of ILD | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 3 year | The 3-year overall survival after HSCT will be evaluated |
Countries
China
Contacts
Primary ContactRen Lin
Outcome results
None listed