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Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure

Primary Purpose

Heart Failure

Status

Unknown status

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Intracoronary injection

Intracoronary injection of Placebo

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiac stem ce heart failure cardiac function intracoronary transplantation

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Royan InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

cardiac stem cell transplantation

Placebo

Arm Description

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

The patients with heart failure that underwent placebo injection.

Outcomes

Primary Outcome Measures

death

evaluation the rate of patients mortality after cardiac stem cell transplantation.

arrhythmia

Evaluation rate of arrhythmia after cardiac stem cell transplantation

hospitalization

Evaluation the rate of hospitalization after cardiac stem cell transplantation

Secondary Outcome Measures

Ejectin fraction changes

evaluation the elevation of ejection fraction in patients after cardiac stem cell transplantation.

Pro BNP changes

Evaluation the reduction of Pro BNP in patients after cardiac stem cell transplantation.

NYHA functional class

Evaluation the improvement of NYHA functional class in patients after cardiac stem cell transplantation.

6MW test

Evaluation the improvement of 6MW test after cardiac stem cell transplantation.

Full Information

NCT ID

NCT01758406

First Posted

December 24, 2012

Last Updated

December 3, 2015

Sponsor

Royan Institute

1. Study Identification

Unique Protocol Identification Number

NCT01758406

Brief Title

Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royan Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Cardiac stem ce heart failure cardiac function intracoronary transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

cardiac stem cell transplantation

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

The patients with heart failure that underwent placebo injection.

Intervention Type

Biological

Intervention Name(s)

Intracoronary injection

Other Intervention Name(s)

autologous cardiac stem cell intracoronary injection

Intervention Description

stem cell transplantation

Intervention Type

Biological

Intervention Name(s)

Intracoronary injection of Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

death

Description

evaluation the rate of patients mortality after cardiac stem cell transplantation.

Time Frame

18months

Title

arrhythmia

Description

Evaluation rate of arrhythmia after cardiac stem cell transplantation

Time Frame

18months

Title

hospitalization

Description

Evaluation the rate of hospitalization after cardiac stem cell transplantation

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Ejectin fraction changes

Description

evaluation the elevation of ejection fraction in patients after cardiac stem cell transplantation.

Time Frame

18months

Title

Pro BNP changes

Description

Evaluation the reduction of Pro BNP in patients after cardiac stem cell transplantation.

Time Frame

18months

Title

NYHA functional class

Description

Evaluation the improvement of NYHA functional class in patients after cardiac stem cell transplantation.

Time Frame

18months

Title

6MW test

Description

Evaluation the improvement of 6MW test after cardiac stem cell transplantation.

Time Frame

18months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nasser Aghdami, MD,PhD

Phone

+9821235622000

Ext

504

nasser.aghdami@royaninstitute.org

First Name & Middle Initial & Last Name or Official Title & Degree

Leila Arab, MD

Phone

+982123562000

Ext

414

leila.arab@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hamid Gourabi, PhD

Organizational Affiliation

Head of Royan Institute

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Nasser Aghdami, MD,PhD

Organizational Affiliation

Head of Royan department of degenerative medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ahmad Amin, MD

Organizational Affiliation

Department of Heart failure,Shahid Rajaee Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Farveh Vakilian, MD

Organizational Affiliation

Department of Heart failure , Imam reza hospital, Mashhad, Iran

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royan Institute

City

Tehran

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nasser Aghdami, MD,PhD

Phone

+982123562000

Ext

504

nasser.aghdami@royaninstitute.org

First Name & Middle Initial & Last Name & Degree

Leila Arab, MD

Phone

+982123562000

Ext

414

leila.arab@yahoo.com

First Name & Middle Initial & Last Name & Degree

Hoda Madani, MD

First Name & Middle Initial & Last Name & Degree

Sadaf Vahdat, PhD student

12. IPD Sharing Statement

Links:

URL

http://Royaninstitute.org

Description

Related Info

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Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure

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