NCT01758406

Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure

Therapeutic Outcome of Intracoronary Transplantation of Autologous Cardiac Stem Cells in Patients With Ischemic Heart Failure: Randomized Double Blind Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Royan Institute · Other Government
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized, double blind , controlled trial to assess the efficacy of intracoronary transplantation of autologous cardiac stem cells in 50 patients with ischemic heart failure.

Detailed description

Heart failure is a common, costly, disabling, and potentially deadly condition. Heart transplantation is the ultimate approach to treating heart failure, but this is costly and excludes patients who are poor candidates for transplantation given their co morbidities, or for whom a donor organ is unavailable. Currently, there is no effective intervention to regenerate dead heart muscle after a heart attack. Our hypothesis is that CSCs regenerates myocardium. In this study all eligible patients are randomly allocated into two study groups by a permuted block randomization method: group A (case group) received 5-10 millions autologous cardiac stem cells, group B (control group) just received placebo. They follow up for 18 months.

Conditions

• Heart Failure

Interventions

Type	Name	Description
BIOLOGICAL	Intracoronary injection	stem cell transplantation
BIOLOGICAL	Intracoronary injection of Placebo	Injection of Placebo via coronary arteries in patients with heart failure.

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-11-01
• Completion: 2017-12-01
• First posted: 2013-01-01
• Last updated: 2015-12-04

Locations

1 site across 1 country: Iran