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Completed

NCT Number: NCT00938847

Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

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.

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Key information

Conditions

Left Ventricular Dysfunction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asklepios Klinik St. Georg, Departement of Cardiology

Hamburg, 20099, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCI

Device

Stent implantation after acute myocardial infarction

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Asklepios proresearch

Industry

Collaborators

  • Cordis US Corp.

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jul 14, 2009
Registry last updated
Jul 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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