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IRCT20211110053033N1 IRCT 2022-01-02 Tehran University of Medical Sciences Determination of safety of allogeneic mesenchymal stem cells by pilot method in patients with cystic fibrosis Determination of the safety of using allogeneic mesenchymal stem cells by pilot method in patients with cystic fibrosis referred to the Children's Medical Center 2021-12-26 anticipated 10 Complete https://irct.ir/trial/60523 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized numbers from one to 10 was produced with a calculator, the first five numbers allocated to intervention group and the other five numbers allocated to control group.Then drugs sequentially from 1 to 10, was given to researcher for prescription to the patients, Blinding description: Drugs and placebos are the same in terms of appearance, color, etc., and thus patients and researchers will not know the contents. N/A Cystic fibrosis. Intervention 1: Intervention group: In 5 patients with cystic fibrosis in the peripheral vein, human allogeneic mesenchymal stem cells (Allo-hMSC ) will be injected in a single dose of 20 million cells. Intervention 2: Control group: In 5 patients with cystic fibrosis, the placebo will be injected as a single dose into the peripheral vein. Yes - There is a plan to make this available What will be shared: Information on the main outcome or the like can be shared. When: Available access 9 months after the publication of results To whom: no Conditions: no Where to obtain: Dr. Faezeh Bolboli How to obtain: Communicating with the person in charge Comments:
public Faezeh Bolboli
Keshavarz Blvd
Tehran Iran (Islamic Republic of) 14197 33151 +98 21 6147 0011 faezeh.bolboli@gmail.com Tehran University of Medical Sciences scientific Faezeh Bolboli
Keshavarz Blvd
Tehran Iran (Islamic Republic of) 14197 33151 +98 21 6147 0011 faezeh.bolboli@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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 12 years 18 years Both The presence of any viral or bacterial infection that has caused pneumonia Patients with Heart Failure Patients with mental and physical disabilities E84 Cystic fibrosis Treatment - Drugs Placebo Intervention group: In 5 patients with cystic fibrosis in the peripheral vein, human allogeneic mesenchymal stem cells (Allo-hMSC ) will be injected in a single dose of 20 million cells. Control group: In 5 patients with cystic fibrosis, the placebo will be injected as a single dose into the peripheral vein. Lung 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). Tehran University of Medical Sciences Approved 2021-07-07 Ethics committee of Tehran University of Medical Sciences Children's Medical Center, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)