drugset / Trial / NCT04005989

Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization

NCT04005989 ↗

Phase 3 Withdrawn Hospital do Coracao
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Treatment of ischemic myocardium has been the subject of intense research in recent years and stem cell therapy is one of the great promises. The InCor laboratory has studied cells from different backgrounds as candidates for cell therapy in the context of myocardial infarction. Evidence in preclinical studies of the application of stromal (mesenchymal) adipose tissue (hASC) in the ischemic heart by both the InCor group (in the animal model in rodents and pigs) and others in the literature suggest relevant benefits on the decrease of deterioration post-infarction. More recently it has been demonstrated that it arises mainly from the formation of new vessels due to paracrine factors, which are secreted by the injected cells. There are currently no studies in Brazil in which the safety of injecting different doses of hASC cells into the heart has been particularly evaluated. Recently, two studies have demonstrated the clinical applicability of hASC in patients with peripheral ischemic disease and stroke. Thus, the objective of this work will be to test the hypothesis that the implantation of autologous stromal cells derived from adipose tissue combined with myocardial revascularization surgery in patients with coronary artery disease

Timeline

Start
2021-12-01
Primary completion
2022-11-30
Completion
2022-12-20

Outcome

Outcome not reported

Stopped: “Due to logistic issues during COVID-19 pandemic”

Drugs

EvaluationDrugModalityDoseRoute
Comparator hASC Cell therapy 1 cells/kg Other
Comparator hASC Cell therapy 2 cells/kg Other
Comparator hASC Cell therapy 4 cells/kg Other