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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Biological: Intracoronary injection; Biological: Intracoronary injection of Placebo

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Royan Institute
    • Contact: Leila Arab, MD; Phone Number: 414 +982123562000; Email: leila.arab@yahoo.com
    • Contact: Nasser Aghdami, MD,PhD; Phone Number: 504 +982123562000; Email: nasser.aghdami@royaninstitute.org
    • Principal Investigator: Hoda Madani, MD
    • Sub-Investigator: Sadaf Vahdat, PhD student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cardiac stem cell transplantation; The patients with heart failure that underwent cardiac stem cell transplantation.	Biological: Intracoronary injection; stem cell transplantation; Other Names: autologous cardiac stem cell intracoronary injection
Placebo Comparator: Placebo; The patients with heart failure that underwent placebo injection.	Biological: Intracoronary injection of Placebo; Injection of Placebo via coronary arteries in patients with heart failure.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Study Director: Nasser Aghdami, MD,PhD, Head of Royan department of degenerative medicine; Study Director: Ahmad Amin, MD, Department of Heart failure,Shahid Rajaee Hospital; Principal Investigator: Farveh Vakilian, MD, Department of Heart failure , Imam reza hospital, Mashhad, Iran

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 24, 2012
• First Submitted That Met QC Criteria: December 24, 2012
• First Posted (Estimate): January 1, 2013

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Cardiac stem ce heart failure cardiac function intracoronary transplantation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Royan-Heart-003