Determination of safety of allogeneic mesenchymal stem cells by pilot method in patients with cystic fibrosis

Not Applicable

Recruiting

• Conditions: Cystic fibrosis.; Cystic fibrosis

• Registration Number: IRCT20211110053033N1
• 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: 11 January 2022

Recruitment & Eligibility

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

Inclusion Criteria

Definitive diagnosis of cystic fibrosis
Severe obstructive disease defined as FEV1 / FVC less than 50%
Acceptable function of other organs including creatinine level less than 1.5 times normal limit in each age group, ALT level less than 135, AST level less than 3 times normal limit in each age group, bilirubin level less than 1.5 times Normal limit in any age group
Normal heart function on echocardiogram
Patients in the age range of 12 to 18 years

Exclusion Criteria

The presence of any viral or bacterial infection that has caused pneumonia
Patients with Heart Failure
Patients with mental and physical disabilities

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ung Volume (Forced expiratory volume in one second);(FEV1). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Spirometry.;Lung Volume (Forced Vital Capacity); (FVC). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Spirometry.;Lung Volume (Forced Expiratory flow 25_75%); (FEF25-75%). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Spirometry.;Forced expiratory volume in 1 second to forced vitalcapacity (FEV1/FVC). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Spirometry.;Walking distance upon 6 minute walking distance test(meter). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Six minute walking distance test.;Body Mass Index. Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Weight (kilogram) divided by height squared (centimetre).