MSC for Treatment of Interstitial Lung Disease After Allo-HSCT

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Bronchiolitis Obliterans; Lung Diseases, Interstitial; Hematopoietic Stem Cell Transplantation

Treatments: Drug: AZM; Biological: MSCs; Drug: Glucocorticoid

Study type: Interventional

Funder types: Other

Identifiers

NCT02543073

MSC-ILD-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

MSCs

Experimental group

Description:

MSCs will be given the patients in MSCs group. Besides, azithromycin (AZM) and glucocorticoid will also be administered.

Treatment:

Biological: MSCs

Drug: AZM

Drug: Glucocorticoid

Non-MSCs

Active Comparator group

Description:

AZM and glucocorticoid will be given for the patients in Non-MSCs group.

Treatment:

Drug: AZM

Drug: Glucocorticoid