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CompletedNCT00199823Updated Jul 6, 2011

Autologous Stem Cell Transplantation in Acute Myocardial Infarction

A Phase 2 interventional study of Intracoronary aotologous stem cell transplantation in Acute Anterior Wall Myocardial Infarction, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-07-06.

Sponsored by Oslo University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

Objectives

Intracoronary transplantation of different cell populations have been used in acute myocardial infarction (AMI) with promising results. The primary objective of the ASTAMI study is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells (mBMC) improve left ventricular ejection fraction (LVEF) after anterior wall AMI.

Design

The ASTAMI study is a randomized, controlled, prospective study. One hundred patients with acute anterior wall ST-elevation myocardial infarction (STEMI) treated with acute PCI are randomized in a 1:1 way to either intracoronary transplantation of autologous mBMC 5-8 days after PCI or to control. Left ventricular function, exercise capacity, biochemical status, functional class, quality of life and complications are validated at baseline and during a 12-month follow up.

02

Conditions studied

  • Acute Anterior Wall Myocardial Infarction

Keywords

  • Myocardial infarction
  • bone marrow cells
  • cell transplantation
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 100 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

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

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age 40-75 years
  • anterior wall AMI with 120-720 minutes from onset of symptoms to PCI
  • ST elevation on ECG according to WHO criteria
  • angiographically significant stenosis on LAD proximal to the second diagonal branch
  • successful PCI with stenting of culprit lesion
  • hypokinetic, akinetic or dyskinetic segments assessed by echocardiography in a standard 16 segment model and
  • CK-MB above 3 times upper reference value.

Exclusion criteria

Exclusion criteria:

  • previous MI with established significant Q-waves on ECG
  • cardiogenic shock
  • permanent pacemaker or other contraindication to MRI
  • stroke with significant sequela
  • short life expectancy due to extra cardiac reason
  • uncontrolled endocrinological disturbance
  • HIV and/or HBV/HCV positive serology
  • mental disorder or other condition which interferes with patient possibility to comply with the protocol.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
100 participants

Interventions

  • GeneticIntracoronary aotologous stem cell transplantation
06

What researchers measure

Primary outcomes

  1. whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.

Secondary outcomes

  1. To test whether mBMC treatment improve exercise capacity assessed by bicycle ergometry

  2. To test whether mBMC treatment improve quality of life assessed by the SF 36 formula

07

Study locations

1 site
  • Rikshospitalet-Radiumhospitalet HF
    Oslo, 0027, Norway
08

References and documents

Publications

  • Lunde K, Solheim S, Aakhus S, Arnesen H, Abdelnoor M, Egeland T, Endresen K, Ilebekk A, Mangschau A, Fjeld JG, Smith HJ, Taraldsrud E, Grogaard HK, Bjornerheim R, Brekke M, Muller C, Hopp E, Ragnarsson A, Brinchmann JE, Forfang K. Intracoronary injection of mononuclear bone marrow cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1199-209. doi: 10.1056/NEJMoa055706. PubMed 16990383 ↗
  • Solheim S, Seljeflot I, Lunde K, Bratseth V, Aakhus S, Forfang K, Arnesen H. The influence of intracoronary injection of bone marrow cells on prothrombotic markers in patients with acute myocardial infarction. Thromb Res. 2012 Nov;130(5):765-8. doi: 10.1016/j.thromres.2011.11.045. Epub 2011 Dec 20. PubMed 22192151 ↗
  • Hopp E, Lunde K, Solheim S, Aakhus S, Arnesen H, Forfang K, Edvardsen T, Smith HJ. Regional myocardial function after intracoronary bone marrow cell injection in reperfused anterior wall infarction - a cardiovascular magnetic resonance tagging study. J Cardiovasc Magn Reson. 2011 Mar 17;13(1):22. doi: 10.1186/1532-429X-13-22. PubMed 21414223 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00199823
Lead sponsor
Oslo University Hospital
Collaborators
University of Oslo, Ullevaal University Hospital
First posted
Sep 20, 2005
Start date
Sep 2003
Completion
May 2006
Last update
Jul 6, 2011

Study contacts

Ketil Lunde, MD
principal investigator · Oslo University Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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