MSC for Treatment of Interstitial Lung Disease After Allo-HSCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Diseases, Interstitial Hematopoietic Stem Cell Transplantation Bronchiolitis Obliterans

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MSCs

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

Group Type EXPERIMENTAL

MSCs

Intervention Type BIOLOGICAL

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

AZM

Intervention Type DRUG

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

Glucocorticoid

Intervention Type DRUG

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

Non-MSCs

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

Group Type ACTIVE_COMPARATOR

AZM

Intervention Type DRUG

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

Glucocorticoid

Intervention Type DRUG

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

Interventions

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MSCs

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

Intervention Type BIOLOGICAL

AZM

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

Intervention Type DRUG

Glucocorticoid

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No