MSC for Treatment of Interstitial Lung Disease After Allo-HSCT

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02543073

Collaborator

Sun Yat-sen University (Other)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases, Interstitial Hematopoietic Stem Cell Transplantation Bronchiolitis Obliterans	Biological: MSCs Drug: AZM Drug: Glucocorticoid	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MSCs MSCs will be given the patients in MSCs group. Besides, azithromycin (AZM) and glucocorticoid will also be administered.	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.
Active Comparator: Non-MSCs AZM and glucocorticoid will be given for the patients in Non-MSCs group.	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.

Arm

Intervention/Treatment

Experimental: MSCs

MSCs will be given the patients in MSCs group. Besides, azithromycin (AZM) and glucocorticoid will also be administered.

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.

Active Comparator: Non-MSCs

AZM and glucocorticoid will be given for the patients in Non-MSCs group.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Overall Survival [3 year]
The 3-year overall survival after HSCT will be evaluated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)