NCT00275977

Brief Summary

The aim of the study is to investigate whether infusion of autologous bone marrow derived stem cells can improve cardiac function in the aftermath of a myocardial infarction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 23, 2010

Status Verified

January 1, 2006

First QC Date

January 10, 2006

Last Update Submit

July 22, 2010

Conditions

Acute Myocardial Infarction

Keywords

"Stem cell""autologous bone marrow transplantation""Myocardial infarction"

Outcome Measures

Primary Outcomes (1)

  • Safety

Secondary Outcomes (1)

  • Change in left ventricular funtion at 4 months followup using contrast enhanced echocardiography

Interventions

Coronary catherization and stem cell infusionPROCEDURE

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chestpain
  • Troponin T, \> 0,1ng/ml
  • Succesfull revascularization of culprit lesion with PCI.
  • No more than stenosis of 2 major epicardiel coronary arteries.

You may not qualify if:

  • Cardiogenic shock
  • Known LVEF\<45%
  • Cardiomyopathy
  • Atrialfibrillation or fluctuation
  • Takyarytmia
  • Infection
  • Chronic inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of endocrinology M, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Related Publications (2)

  • Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H. Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial. Lancet. 2004 Jul 10-16;364(9429):141-8. doi: 10.1016/S0140-6736(04)16626-9.

    PMID: 15246726BACKGROUND

  • Schachinger V, Assmus B, Britten MB, Honold J, Lehmann R, Teupe C, Abolmaali ND, Vogl TJ, Hofmann WK, Martin H, Dimmeler S, Zeiher AM. Transplantation of progenitor cells and regeneration enhancement in acute myocardial infarction: final one-year results of the TOPCARE-AMI Trial. J Am Coll Cardiol. 2004 Oct 19;44(8):1690-9. doi: 10.1016/j.jacc.2004.08.014.

    PMID: 15489105BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Moustapha Kassem, MD, Ph.D

    Department of endocrinology M, Odense University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Malthe AM Kristiansen, MD

CONTACT

+45 65504081mkristiansen@health.sdu.dk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

February 1, 2006

Study Completion

March 1, 2007

Last Updated

July 23, 2010

Record last verified: 2006-01

Locations

DK(1)