Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure

Royan Institute

Status and phase: Unknown; Phase 2

Conditions: Heart Failure

Treatments: Biological: Intracoronary injection of Placebo; Biological: Intracoronary injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01758406

Royan-Heart-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

cardiac stem cell transplantation

Experimental group

Description:

The patients with heart failure that underwent cardiac stem cell transplantation.

Treatment:

Biological: Intracoronary injection

Placebo

Placebo Comparator group

Description:

The patients with heart failure that underwent placebo injection.

Treatment:

Biological: Intracoronary injection of Placebo