MSC for Treatment of Interstitial Lung Disease After Allo-HSCT

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mesenchymal Stem Cell for Treatment of Interstitial Lung Disease After Allogenetic Hematopoietic Stem Cell Transplantation

Conditions
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Lung Diseases, Interstitial, Hematopoietic Stem Cell Transplantation, Bronchiolitis Obliterans

Intervention / Treatment
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* Biological: MSCs
* Drug: AZM
* Drug: Glucocorticoid


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSCs<br>MSCs will be given the patients in MSCs group. Besides, azithromycin (AZM) and glucocorticoid will also be administered. | Biological: MSCs<br>* MSCs will be given at a median dose of 1×10^6 cells/kg once weekly for 4 weeks as one cycle treatment.<br>Drug: AZM<br>* AZM will be given （0.25g qd）for 4 weeks as one cycle treatment.<br>Drug: Glucocorticoid<br>* Glucocorticoid (prednison) will be given at the starting dose of 1mg/kg for 4 weeks as one cycle treatment.<br>|
| Active Comparator: Non-MSCs<br>AZM and glucocorticoid will be given for the patients in Non-MSCs group. | Drug: AZM<br>* AZM will be given （0.25g qd）for 4 weeks as one cycle treatment.<br>Drug: Glucocorticoid<br>* Glucocorticoid (prednison) will be given at the starting dose of 1mg/kg for 4 weeks as one cycle treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The 3-year overall survival after HSCT will be evaluated | 3 year |