Overview

This trial is active, not recruiting.

Conditions lung diseases, interstitial, hematopoietic stem cell transplantation, bronchiolitis obliterans
Treatments mscs, azm, glucocorticoid
Phase phase 1/phase 2
Sponsor Nanfang Hospital of Southern Medical University
Collaborator Sun Yat-sen University
Start date September 2014
End date December 2016
Trial size 60 participants
Trial identifier NCT02543073, MSC-ILD-2015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
MSCs will be given the patients in MSCs group. Besides, azithromycin (AZM) and glucocorticoid will also be administered.
mscs
MSCs will be given at a median dose of 1×10^6 cells/kg once weekly for 4 weeks as one cycle treatment.
azm
AZM will be given (0.25g qd)for 4 weeks as one cycle treatment.
glucocorticoid
Glucocorticoid (prednison) will be given at the starting dose of 1mg/kg for 4 weeks as one cycle treatment.
(Active Comparator)
AZM and glucocorticoid will be given for the patients in Non-MSCs group.
azm
AZM will be given (0.25g qd)for 4 weeks as one cycle treatment.
glucocorticoid
Glucocorticoid (prednison) will be given at the starting dose of 1mg/kg for 4 weeks as one cycle treatment.

Primary Outcomes

Measure
Response rate of ILD
time frame: 4 weeks

Secondary Outcomes

Measure
Overall Survival
time frame: 3 year

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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)

Additional Information

Official title Mesenchymal Stem Cell for Treatment of Interstitial Lung Disease After Allogenetic Hematopoietic Stem Cell Transplantation
Principal investigator Qifa Liu, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Nanfang Hospital of Southern Medical University.