MSC for Treatment of Interstitial Lung Disease After Allo-HSCT

Nanfang Hospital, Southern Medical University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Diseases, Interstitial Hematopoietic Stem Cell Transplantation Bronchiolitis Obliterans

Interventions

MSCsBIOLOGICAL

MSCs will be given at a median dose of 1×10\^6 cells/kg once weekly for 4 weeks as one cycle treatment.

AZMDRUG

AZM will be given （0.25g qd）for 4 weeks as one cycle treatment.

GlucocorticoidDRUG

Glucocorticoid (prednison) will be given at the starting dose of 1mg/kg for 4 weeks as one cycle treatment.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

Overall Survival

The 3-year overall survival after HSCT will be evaluated

Time frame: 3 year

Central Contacts

Ren Lin

CONTACT

lansinglinren@hotmail.com

Data from ClinicalTrials.gov

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