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Study aim
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Determination of intravenous injection of dental pulp mesenchymal stem cells in the treatment of patients with idiopathic pulmonary fibrosis - Phase 1 and 2 clinical trial
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Design
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Clinical trial, with control group, with parallel groups, without blinding, without randomization, phase 1 and 2, on 60 patients
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Settings and conduct
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This study is being conducted in the field of pulmonary diseases. The location of the study is Afzalipour Hospital and the Comprehensive Center for Cell Therapy and Regenerative Medicine of Kerman University of Medical Sciences. After the patient is selected by the physician, the mesenchymal stem cells are injected into the patient by the physician. The patients will be followed up every 12 weeks to 1 year after the injection.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 1- Probable diagnosis of limited interstitial pneumonia, 2- Exclusion of other diagnoses, 3- At least 3 months have passed since diagnosis and have disease-related abnormalities, 4- Discontinuation of N-acetylcysteine or pirfenidone 6 weeks before starting treatment
Exclusion criteria: 1- with severe IPF, 2-with lung cancer, 3- with uncontrolled underlying disease, 4- with neurological abnormalities, 5- treated with anticoagulant drugs, 6- with active infection, 7- whose condition cannot be followed up.
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Intervention groups
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Thirty patients will be in the intervention group, where they will receive an injection of mesenchymal stem cells. 30 patients will also be in the control group, where they will receive standard treatments. Follow up will also be performed for these individuals every 12 weeks to 1 year, and the results will be compared between the groups.
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Main outcome variables
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Lung diffusing capacity; total lung volume; measurement of overall health of individuals; ratio of arterial oxygen pressure to inspiratory oxygen pressure; condition of the lungs