Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure

Phase 2

• Conditions: Heart Failure
• Interventions: Biological: Intracoronary injection of Placebo; Biological: Intracoronary injection

• Registration Number: NCT01758406
• Lead Sponsor: Royan Institute

Brief 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.

Study Timeline

• Study First Submitted: 2012-12-24
• Study First Submitted QC: 2012-12-24
• Study First Posted: 2013-01-01
• Study Start: 2013-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04
• Primary Completion: 2017-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1- EF≤40 (by Echocardiography) 2- Not responding to standard therapies for heart failure >1m 3- NYHA class ≥ III 4- Myocardial infarction due to coronary artery atherosclerotic disease 5-An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI) 6-No HIV/Viral hepatitis 7-Normal liver function (SGPT < 3 times the upper reference range) 8-No or controlled diabetes (hemoglobin A1C < 8.5%) 9- Ability to provide informed consent and follow-up with protocol procedures

Exclusion Criteria

• 1 prior ICD placement(<2w)/Sustained ventricular arrhythmias 2-Cardiogenic shock 3- pregnancy and Child-bearing 4- Congenital / valvular heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Intracoronary injection of Placebo	The patients with heart failure that underwent placebo injection.
cardiac stem cell transplantation	Intracoronary injection	The patients with heart failure that underwent cardiac stem cell transplantation.

Primary Outcome Measures

Name	Time	Method
arrhythmia	18months	Evaluation rate of arrhythmia after cardiac stem cell transplantation
death	18months	evaluation the rate of patients mortality after cardiac stem cell transplantation.
hospitalization	18 months	Evaluation the rate of hospitalization after cardiac stem cell transplantation

Secondary Outcome Measures

Name	Time	Method
6MW test	18months	Evaluation the improvement of 6MW test after cardiac stem cell transplantation.
Pro BNP changes	18months	Evaluation the reduction of Pro BNP in patients after cardiac stem cell transplantation.
NYHA functional class	18months	Evaluation the improvement of NYHA functional class in patients after cardiac stem cell transplantation.
Ejectin fraction changes	18months	evaluation the elevation of ejection fraction in patients after cardiac stem cell transplantation.

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of