Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by Royan Institute
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01758406
First received: December 24, 2012
Last updated: April 24, 2014
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Heart Failure
Biological: Intracoronary injection
Biological: Intracoronary injection of Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Outcome of Intracoronary Transplantation of Autologous Cardiac Stem Cells in Patients With Ischemic Heart Failure: Randomized Double Blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • death [ Time Frame: 18months ] [ Designated as safety issue: Yes ]
    evaluation the rate of patients mortality after cardiac stem cell transplantation.

  • arrhythmia [ Time Frame: 18months ] [ Designated as safety issue: Yes ]
    Evaluation rate of arrhythmia after cardiac stem cell transplantation

  • hospitalization [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Evaluation the rate of hospitalization after cardiac stem cell transplantation


Secondary Outcome Measures:
  • Ejectin fraction changes [ Time Frame: 18months ] [ Designated as safety issue: No ]
    evaluation the elevation of ejection fraction in patients after cardiac stem cell transplantation.

  • Pro BNP changes [ Time Frame: 18months ] [ Designated as safety issue: No ]
    Evaluation the reduction of Pro BNP in patients after cardiac stem cell transplantation.

  • NYHA functional class [ Time Frame: 18months ] [ Designated as safety issue: No ]
    Evaluation the improvement of NYHA functional class in patients after cardiac stem cell transplantation.

  • 6MW test [ Time Frame: 18months ] [ Designated as safety issue: No ]
    Evaluation the improvement of 6MW test after cardiac stem cell transplantation.


Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cardiac stem cell transplantation
The patients with heart failure that underwent cardiac stem cell transplantation.
Biological: Intracoronary injection
stem cell transplantation
Other Name: 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.

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.

  Eligibility

Ages Eligible for Study:   14 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758406

Contacts
Contact: Nasser Aghdami, MD,PhD +9821235622000 ext 504 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD +982123562000 ext 414 leila.arab@yahoo.com

Locations
Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD    +982123562000 ext 504    nasser.aghdami@royaninstitute.org   
Contact: Leila Arab, MD    +982123562000 ext 414    leila.arab@yahoo.com   
Principal Investigator: Hoda Madani, MD         
Sub-Investigator: Sadaf Vahdat, PhD student         
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
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
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01758406     History of Changes
Other Study ID Numbers: Royan-Heart-003
Study First Received: December 24, 2012
Last Updated: April 24, 2014
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Cardiac stem ce heart failure cardiac function intracoronary transplantation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014