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MSC for Treatment of Interstitial Lung Disease After Allo-HSCT

This study is currently recruiting participants.
Verified September 2015 by Qifa Liu, Nanfang Hospital of Southern Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02543073
First Posted: September 7, 2015
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University
  Purpose
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 Intervention Phase
Lung Diseases, Interstitial Hematopoietic Stem Cell Transplantation Bronchiolitis Obliterans Biological: MSCs Drug: AZM Drug: Glucocorticoid Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Qifa Liu, Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • Response rate of ILD [ Time Frame: 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 [ Time Frame: 3 year ]
    The 3-year overall survival after HSCT will be evaluated


Estimated Enrollment: 60
Study Start Date: September 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543073


Contacts
Contact: Ren Lin lansinglinren@hotmail.com

Locations
China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Ren Lin, MD    +86-020-61641613    lansinglinren@hotmail.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Sun Yat-sen University
Investigators
Principal Investigator: Qifa Liu, MD Nanfang Hospital of Southern Medical University
  More Information

Publications:
Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02543073     History of Changes
Other Study ID Numbers: MSC-ILD-2015
First Submitted: September 4, 2015
First Posted: September 7, 2015
Last Update Posted: May 10, 2017
Last Verified: September 2015

Additional relevant MeSH terms:
Lung Diseases
Bronchiolitis
Lung Diseases, Interstitial
Bronchiolitis Obliterans
Respiratory Tract Diseases
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs