Alster Stem Cells - Intramyocardial Stem Therapy

Asklepios proresearch40 enrolled

Overview

Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myocardial Infarction Early Left Ventricular Dysfunction

Interventions

Percutaneous Coronary InterventionPROCEDURE

common Percutaneous Coronary Intervention

BMNC therapyPROCEDURE

Injection of BMNC after common PCI

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * LVDF \< 45% after timely (max. 6 hours after the onset of symptomps) successful PCI * conventional therapy according to the ESC guidelines for heart failure * BMI \> 20 and \< 35 Exclusion Criteria: * PCI elder then 21 days * relevant valvular disease * history of stroke/multivessel disease/thromboembolic event etc. * DM Type I * pregancy

Locations (1)

Asklepios Klinik St. Georg

Hamburg, Germany

Outcomes

Primary Outcomes

Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).

Time frame: 12 months

Secondary Outcomes

Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration.

Time frame: 12 months

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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