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Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure

NCT ID: NCT01758406

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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cardiac stem cell transplantation

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

Group Type EXPERIMENTAL

Intracoronary injection

Intervention Type BIOLOGICAL

stem cell transplantation

Placebo

The patients with heart failure that underwent placebo injection.

Group Type PLACEBO_COMPARATOR

Intracoronary injection of Placebo

Intervention Type BIOLOGICAL

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

Interventions

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Intracoronary injection

stem cell transplantation

Intervention Type BIOLOGICAL

Intracoronary injection of Placebo

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

Intervention Type BIOLOGICAL

Other Intervention Names

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autologous cardiac stem cell intracoronary injection

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Nasser Aghdami, MD,PhD

Role: STUDY_DIRECTOR

Head of Royan department of degenerative medicine

Ahmad Amin, MD

Role: STUDY_DIRECTOR

Department of Heart failure,Shahid Rajaee Hospital

Farveh Vakilian, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Royan Institute

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Nasser Aghdami, MD,PhD

Role: CONTACT

[email protected]
+9821235622000 ext. 504

Leila Arab, MD

Role: CONTACT

[email protected]
+982123562000 ext. 414

Facility Contacts

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Nasser Aghdami, MD,PhD

Role: primary

[email protected]
+982123562000 ext. 504

Leila Arab, MD

Role: backup

[email protected]
+982123562000 ext. 414

Related Links

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http://Royaninstitute.org

Related Info

Other Identifiers

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Royan-Heart-003

Identifier Type: -

Identifier Source: org_study_id