Safety and efficacy of Mesenchymal Stem Cell administration in Bronchiolitis Obliterans Syndrome.

Not Applicable

Recruiting

• Conditions: bronchiolitis obliterans.; Respiratory bronchiolitis interstitial lung disease; J84.115

• Registration Number: IRCT20201202049568N2
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Age below 16 years
Allogeneic hematopoietic stem cell transplantation (HSCT) over the past year
Forced Expiratory Volume in one second (FEV1) < 70 % (based on Pulmonary Function Test)
Diagnosis of BOS in end-stage phase with the history and clinical evaluation by a pediatric pulmonologist, and the presence of air-trapping or small airway involvement in high-resolution computed tomography (HRCT)
Absence of concomitant infections
Irresponsible to full-dose corticosteroids
Give the informed consent by the patients' legal guardians

Exclusion Criteria

Suspicion to any bacterial or viral pneumonia
CMV, VZV, HSV and/or fungal pneumonia
Haploidentical and/or T-cell deplete transplantation
Prior history of allergy or sensitivity to drugs
Relapse or progression of underlying malignancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume in one second (FEV1). Timepoint: Before intervention and then 1,3,6 months after intervention. Method of measurement: Pulmonary Function Test (Spirometry).;FEV1/FVC ratio. Timepoint: Before intervention and then 1,3,6 months after intervention. Method of measurement: Pulmonary Function Test (Spirometry).

Secondary Outcome Measures

Name	Time	Method
Fractional exhaled nitric oxide (FeNO). Timepoint: Before intervention and then 1,3,6 months after intervention. Method of measurement: FeNO test.