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CompletedNCT00938847Updated Jul 14, 2009

Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

A Phase 3 interventional study of PCI in Left Ventricular Dysfunction, sponsored by Asklepios proresearch. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-07-14.

Sponsored by Asklepios proresearch · Phase 3, Interventional, and Basic science

Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Left Ventricular Dysfunction

Keywords

  • left ventricular dysfunction
  • myocardial infarction
  • left ventricular dysfunction (LVDF) after acute myocardial infarction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 20 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Asklepios proresearch is the lead sponsor of 17 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • LVEF \<40%
  • PCI at latest 6 hours after infarction
  • BMI >20 kg/m² and \<30 kg/m²

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Interventions

  • DevicePCI

    Stent implantation after acute myocardial infarction

06

What researchers measure

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

07

Study locations

1 site
  • Asklepios Klinik St. Georg, Departement of Cardiology
    Hamburg, 20099, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00938847
Lead sponsor
Asklepios proresearch
Collaborators
Cordis Corporation
First posted
Jul 14, 2009
Start date
Feb 2006
Primary completion
Oct 2007
Completion
Oct 2008
Last update
Jul 14, 2009

Study contacts

Karl-Heinz Kuck, Prof. Dr. med.
principal investigator · Asklepios Klinik St. Georg, Departement of Cardiology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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