MSC for Treatment of Interstitial Lung Disease After Allo-HSCT
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|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Response rate of ILD
time frame: 4 weeks
time frame: 3 year
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)
|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.|
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