MSC for Treatment of Interstitial Lung Disease After Allo-HSCT

Phase 1

• Conditions: Hematopoietic Stem Cell Transplantation; Bronchiolitis Obliterans; Lung Diseases, Interstitial
• Interventions: Drug: AZM; Biological: MSCs; Drug: Glucocorticoid

• Registration Number: NCT02543073
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-09
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MSCs	Glucocorticoid	MSCs will be given the patients in MSCs group. Besides, azithromycin (AZM) and glucocorticoid will also be administered.
Non-MSCs	AZM	AZM and glucocorticoid will be given for the patients in Non-MSCs group.
MSCs	MSCs	MSCs will be given the patients in MSCs group. Besides, azithromycin (AZM) and glucocorticoid will also be administered.
MSCs	AZM	MSCs will be given the patients in MSCs group. Besides, azithromycin (AZM) and glucocorticoid will also be administered.
Non-MSCs	Glucocorticoid	AZM and glucocorticoid will be given for the patients in Non-MSCs group.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall Survival	3 year	The 3-year overall survival after HSCT will be evaluated

Trial Locations

Locations (1)

Department of Hematology,Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China