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NCT05669144
Co-transplantation of Mesenchymal Stem Cell Derived Exosomes and Autologous Mitochondria for Patients Candidate for CABG Surgery
Conditions: Myocardial Infarction, Myocardial Ischemia, Myocardial Stunning
Sex: All
Ages: 35 Years – 80 Years
Phase: PHASE1, PHASE2
Enrollment: 20
Sponsor: Tehran University of Medical Sciences
Location: Iran, Islamic Republic of
Summary
Heart failure (HF) and acute myocardial infarction that often follows are among the main causes of disability and death worldwide.
As such, new treatments and biological drugs are needed to protect the heart against the harmful effects of ischemia and also reperfusion injury (IRI), preserve cardiac function, reduce the zone of myocardial infarction (MI), and improve patient outcomes.
In this regard, it has been shown that mitochondrial dysfunction has a key role in the pathogenesis of heart ischemia, cardiomyopathy, and reperfusion injury. in this study which includes 4 groups of intervention, we try to minimize the damage by transplantation of mitochondria and administration of MSC-derived exosomes.
MSC-derived exosomes limit inflammatory damage while fresh autologous exosomes limit oxidative stress.
Eligibility Criteria
Inclusion Criteria:• Patients who are candidate for CABG due to CAD±MRHistory of Q-wave MI, less than one monthAge: 35-80LVEF <=25% (by any imaging modality: echocardiography/SPECT/LV angiography and Cardiac MRI)Viability study as evidenced by low-dose dobutamine stress echocardiogram and/or or thallium redistribution nuclear study (at least four viable segments).Exclusion Criteria:Severe co-morbidities (e.g., renal failure, liver failure, etc.)Inability to provide informed consentCerebral Damage
Source: ClinicalTrials.gov (NCT05669144). StuddyBuddy aggregates publicly available trial information.