Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

Asklepios proresearch20 enrolled

Overview

Evaluative pilot study for safety and feasibility with administration of autologous bone bone marrow derived mononuclear cells by endoventricular catheter into the normal border zone fo the ischemic lesion.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Left Ventricular Dysfunction

Interventions

PCIDEVICE

Stent implantation after acute myocardial infarction

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * LVEF \<40% * PCI at latest 6 hours after infarction * BMI \>20 kg/m² and \<30 kg/m² Exclusion Criteria: * PCI elder than 14 days * relevant valvular disease * left ventricular dysfunction caused by other reasons than ischemic cardiomyopathy * history of stroke, chronic atrial fibrillation, multivessel disease, thromboembolic event * scheduled for CABG * DM Type 1 \& extensive hypercholesterinemia * pacemaker * systemic disease * Pregnancy

Locations (1)

Asklepios Klinik St. Georg, Departement of Cardiology

Hamburg, Germany

Outcomes

Primary Outcomes

Demonstration of safety and feasibility of BM-MNC treatment. Investigation of the suitability of endocardial left ventricular electromechanical mapping (LVEMM) with NOGA as endpoint for myocardial regeneration.

Time frame: 12 months

Secondary Outcomes

Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.

Time frame: 12 months

Data from ClinicalTrials.gov

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