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IRCT20210317050737N2 IRCT 2023-02-06 Kerman University of Medical Sciences The role of stem cells in the treatment of primary pulmonary hypertension PAH Determining the effect of stem cell injection on clinical symptoms and echocardiographic findings of children with primary pulmonary artery hypertension 2022-11-22 anticipated 20 Complete https://irct.ir/trial/66539 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The use of stem cells in the treatment of pulmonary hypertension is currently limited, Randomization description: With the simple random method, random selection method is used to determine the position of the first sample. Names of patients are written on similar papers and placed in a bag.The first paper is randomly take out from the bag. This number represents the first person who is placed in the stem cell injection group, the patient with the next number enters the drug treatment group and this is repeated in order until the sample volume is complete. N/A Primary pulmonary hypertension. Intervention 1: Intervention group: Stem cell injection of one and a half milliliter per kilogram of the patient's weight from processed stem cells with a concentration of one million stem cells in 200 microliters intravenously and through a peripheral vein. Intervention 2: Control group: Prescription of tadalafil at the rate of1 milligram per kilogram weight per day for two weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Maryam Ahmadipour
Afzalipour Hospital,Emam Blvd
Kerman Iran (Islamic Republic of) 7616913355 +98 34 2235 0118 maryam.ahmadipour5@gmail.com Kerman University of Medical Sciences scientific Maryam Ahmadipour
Afzalipour Hospital ,Emam Blvd
Kerman Iran (Islamic Republic of) 7616913355 +98 34 2235 0118 maryam.ahmadipour5@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) All patients aged 3-8 years diagnosed with primary pulmonary hypertension 3 years 18 years Both Accompanying congenital heart disease Secondary causes of pulmonary hypertension I27.0 Primary pulmonary hypertension Treatment - Drugs Treatment - Drugs Intervention group: Stem cell injection of one and a half milliliter per kilogram of the patient's weight from processed stem cells with a concentration of one million stem cells in 200 microliters intravenously and through a peripheral vein. Control group: Prescription of tadalafil at the rate of1 milligram per kilogram weight per day for two weeks. Pulmonary arterial pressure. Timepoint: Before injection and after injection at intervals of 24 and 48 hours, one and 6 months later. Method of measurement: Transthoracic echocardiography. 6 minute walk test. Timepoint: Before injection and after injection at intervals of 24 and 48 hours, one and 6 months later. Method of measurement: Observing and measuring the distance traveled. Arterial oxygen saturation percentage. Timepoint: Before injection and after injection at intervals of 24 and 48 hours, one and 6 months later. Method of measurement: Pulse oximetry. Kerman University of Medical Sciences Approved 2022-10-30 Ethics committee of Kerman University of Medical Sciences Afzalipour Hospital,Emam Blvd,Kerman Town kerman Kerman Iran (Islamic Republic of)