Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration in Early Left Ventricular Dysfunction After Acute Myocardial Infarction And Successful Percutaneous Coronary Intervention

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00938847

Enrollment

Registered

2009-07-14

Start date

2006-02-28

Completion date

2008-10-31

Last updated

2009-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Ventricular Dysfunction

Keywords

left ventricular dysfunction, myocardial infarction, left ventricular dysfunction (LVDF) after acute myocardial infarction

Brief summary

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.

Interventions

DEVICEPCI

Stent implantation after acute myocardial infarction

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	12 months

Secondary

Measure	Time frame
Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.	12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026