Clinical trial NCT01758406: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Heart Failure
Keywords: Cardiac stem ce heart failure cardiac function intracoronary transplantation
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2013-01-01
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: death
timeFrame: 18months
measure: arrhythmia
timeFrame: 18months
measure: hospitalization
timeFrame: 18 months
Secondary outcomes:
measure: Ejectin fraction changes
timeFrame: 18months
measure: Pro BNP changes
timeFrame: 18months
measure: NYHA functional class
timeFrame: 18months
measure: 6MW test
timeFrame: 18months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of Royan department of degenerative medicine
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Department of Heart failure,Shahid Rajaee Hospital
name: Ahmad Amin, MD
role: STUDY_DIRECTOR
affiliation: Department of Heart failure , Imam reza hospital, Mashhad, Iran
name: Farveh Vakilian, MD
role: PRINCIPAL_INVESTIGATOR
References: