Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

Left Ventricular Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938847
• Other study ID #: 996
• Secondary ID: 2005-003629-1925
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2009
• Last updated: July 13, 2009
• Start date: February 2006
• Est. completion date: October 2008

Study information

• Verified date: July 2009
• Source: Asklepios proresearch
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry for Social and Family Affairs, Health and Consumer Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Left Ventricular Dysfunction
• Myocardial Infarction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• PCI
Stent implantation after acute myocardial infarction

Locations

Country	Name	City	State
Germany	Asklepios Klinik St. Georg, Departement of Cardiology	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Asklepios proresearch	Cordis Corporation

Country where clinical trial is conducted

Germany, 

Outcome

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