REPAIR-AMI: Intracoronary Progenitor Cells in Acute Myocardial Infarction (AMI)
Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Myocardial Infarction (REPAIR - AMI)
  • Phase

    Phase 3
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

Impaired contractile function after a heart attack of the heart is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy, including immediate balloon/stent dilation of the infarct vessel.

The aim of the REPAIR-AMI trial is to investigate whether infusion of progenitor cells into the infarct vessel (after successful reperfusion therapy) may improve left ventricular contractile function compared to placebo therapy. After bone marrow aspiration progenitor cells are enriched via a centrifugation method.
The study is a double-blind, placebo-controlled, randomized, multicenter trial.
Patients after an acute myocardial infarction, undergoing successful reperfusion therapy are included.
All patients undergo bone marrow aspiration 3 to 6 days after the infarction.
After cell processing, enriched bone marrow-derived progenitor cells or placebo medium is infused direct into the infarct related artery during stop-flow. In addition, a left ventricular angiography is performed.
After 4 months left ventricular angiography is repeated. The primary endpoint is the difference in change of left ventricular ejection fraction between the two groups.
Study Started
Apr 30
Primary Completion
Oct 31
Study Completion
Dec 31
Last Update
Sep 20

Biological Intracoronary infusion of enriched bone marrow-derived progenitor cells

Biological Placebo medium supplemented with autologous serum

BMC Experimental

Intracoronary infusion of autologous bone marrow derived cells

Placebo Placebo Comparator

Intracoronary infusion of Placebo medium


Inclusion Criteria:

Patients with acute myocardial infarction (ST elevation in at least 2 leads >= 0.2 mV in V1,V2 or V3 or >= 0.1 mV in other leads), treated by one of the following procedures

Either acute PCI with stent implantation within 24 hours after symptom onset or
treatment with thrombolysis within 12 hours of symptom onset followed by PCI with stent implantation within 24 hours after thrombolysis.
Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow >= 2).
At the time of inclusion patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
Significant regional wall motion abnormality in LV angiogram at the time of acute PCI (ejection fraction <= 45% on visual estimation).
Maximal CK elevation >= 400 U/l (measured at 37° C) with significant MB fraction > 6%
Age 18 - 80 Years
Written informed consent

Exclusion Criteria:

Regional wall motion abnormality outside the area involved in the index acute myocardial infarction.
Need to revascularize additional vessels, outside the infarct artery.
Arteriovenous malformations or aneurysms
Active infection (CRP > 10 mg/dl) now, or fever or diarrhea within last 4 weeks.
Chronic inflammatory disease
HIV infection or active hepatitis
Neoplastic disease without documented remission within the past 5 years.
Cerebrovascular insult within 3 months
Impaired renal function (creatinine > 2 mg/dl) at the time of cell therapy
Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5)
Anemia (hemoglobin < 8.5 mg/dl)
Platelet count < 100.000/µl
Known allergy or intolerance to clopidogrel, heparin or abciximab.
History of bleeding disorder
Gastrointestinal bleeding within 3 months
Major surgical procedure or traumata within 2 months
Uncontrolled hypertension
Mental retardation
Previously performed stem / progenitor cell therapy
Participation in another clinical trial within the last 30 days.
No Results Posted