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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01758406

Enrollment

Registered

2013-01-01

Start date

2013-12-31

Completion date

2017-12-31

Last updated

2015-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Cardiac stem ce heart failure cardiac function intracoronary transplantation

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.

Interventions

BIOLOGICALIntracoronary injection

stem cell transplantation

BIOLOGICALIntracoronary injection of Placebo

Injection of Placebo via coronary arteries in patients with heart failure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

14 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
death	18months	evaluation the rate of patients mortality after cardiac stem cell transplantation.
arrhythmia	18months	Evaluation rate of arrhythmia after cardiac stem cell transplantation
hospitalization	18 months	Evaluation the rate of hospitalization after cardiac stem cell transplantation

Secondary

Measure	Time frame	Description
Ejectin fraction changes	18months	evaluation the elevation of ejection fraction in patients after cardiac stem cell transplantation.
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.

Countries

Iran

Contacts

Primary ContactNasser Aghdami, MD,PhD

nasser.aghdami@royaninstitute.org+9821235622000

Backup ContactLeila Arab, MD

leila.arab@yahoo.com+982123562000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026