Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01758406
• Other study ID #: Royan-Heart-003
• Status: Recruiting
• Phase: Phase 2
• First received: December 24, 2012
• Last updated: December 3, 2015
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: November 2015
• Source: Royan Institute
• Contact: Nasser Aghdami, MD,PhD
• Phone: +9821235622000
• Email: nasser.aghdami[@]royaninstitute.org
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Biological:
• Intracoronary injection
stem cell transplantation
• Intracoronary injection of Placebo
Injection of Placebo via coronary arteries in patients with heart failure.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	evaluation the rate of patients mortality after cardiac stem cell transplantation.	18months	Yes
Primary	arrhythmia	Evaluation rate of arrhythmia after cardiac stem cell transplantation	18months	Yes
Primary	hospitalization	Evaluation the rate of hospitalization after cardiac stem cell transplantation	18 months	Yes
Secondary	Ejectin fraction changes	evaluation the elevation of ejection fraction in patients after cardiac stem cell transplantation.	18months	No
Secondary	Pro BNP changes	Evaluation the reduction of Pro BNP in patients after cardiac stem cell transplantation.	18months	No
Secondary	NYHA functional class	Evaluation the improvement of NYHA functional class in patients after cardiac stem cell transplantation.	18months	No
Secondary	6MW test	Evaluation the improvement of 6MW test after cardiac stem cell transplantation.	18months	No

External Links

•   Link