Evaluation of the Intramyocardial Injection of Autologous Bone Marrow Derived Mononuclear Stem Cells in Heart Failure (HF) Patients

SCARM Institute, Tabriz, Iran1 site in 1 country5 target enrollmentOctober 14, 2020

ConditionsHeart Failure

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Heart Failure
Sponsor: SCARM Institute, Tabriz, Iran
Enrollment: 5
Locations: 1
Primary Endpoint: Death
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess the Evaluation of the intramyocardial injection of autologous bone marrow derived mononuclear stem cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(<=30%) when compared to a control group of patients undergoing best medical care.

Registry

clinicaltrials.gov

Start Date

October 14, 2020

End Date

October 12, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

SCARM Institute, Tabriz, Iran

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and women of any ethnic origin 18 ≤ aged≤ 65 years
•EF≤40 (by Echocardiography) and regional wall motion abnormality
•Not responding to standard therapies
•the New York Heart Association (NYHA) class ≥ III
•Myocardial infarction due to coronary artery atherosclerotic disease
•An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI)
•Normal liver and renal function
•No or controlled diabetes
•Able to give voluntary written consent and understand the study information provided to him

Exclusion Criteria

•Participation in another clinical trial within 30 days prior randomisation
•Previously received stem/progenitor cell therapy
•Pregnant women
•Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
•Cardiogenic shock requiring mechanical support
•Congenital / valvular heart disease
•Implantable cardioverter defibrillator (ICD) transplant
•Platelet count \<100.000/µl, or hemoglobin \<8.5 g/dl
•Impaired renal function, i.e. creatinine \>2.5 mg/dl
•Fever or diarrhea within 4 weeks prior screening