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Acute Myocardial InfarctionPhase 1NCT00275977

Treatment of Myocardial Infarction With Bone Marrow Derived Stem Cells

A Phase 1 study testing Coronary catherization and stem cell infusion in people with Acute Myocardial Infarction, run by Odense University Hospital at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Coronary catherization and stem cell infusion
How many people
10 participants
Where
1 siteDenmark
Study dates
Feb 2006to Mar 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malthe AM Kristiansen, MD contact

+45 65504081

mkristiansen@health.sdu.dk

Denmark1 site, 1 recruiting

  • Department of endocrinology M, Odense University Hospital

    Odense, 5000

    Malthe AM Kristiansen, MD

    Moustapha Kassem, MD, Ph.D

    Recruiting

Other trials in Denmark

About this study

Official title: Treatment of Myocardial Infarction With Autologous Bone Marrow Derived Stem Cells

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.

Read the detailed description

Primary coronary intervention within a few hours of a myocardial infarction has greatly reduced mortality as well as the risk of developing chronic heart failure. There are though still a large number of patients that develop symptoms of heart failure in the form of fatigue and breathlessness with physical exertion in spite of medical treatment. With the advance in stem cell technology there is now hope for the possibility of regenerating/repairing dead myocardial tissue, hence improving cardiac function.

The current study is a pilot study that is going to precede a later double blinded randomized study. The aim of the study is to evaluate patient safety, optimize procedures, and to be used in power calculation in the design of the following study.

Being tested
Coronary catherization and stem cell infusion
Keywords
"Stem cell", "autologous bone marrow transplantation", "Myocardial infarction"
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary catherization and stem cell infusionProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2006 (estimated)
  2. Study startFeb 2006
  3. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00275977
Sponsor's protocol ID
020
Status last verified
Jan 2006
First submitted
10 Jan 2006
Last updated
23 Jul 2010
Results posted
No

Publications

  • 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.

    PubMed 15246726

  • 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.

    PubMed 15489105

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Coronary catherization and stem cell infusion in people with Acute Myocardial Infarction, run by Odense University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Malthe AM Kristiansen, MD (+45 65504081, mkristiansen@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00275977, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2010.

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