Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)

University of Ulm

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease; Acute Myocardial Infarction

Treatments: Other: autologous stem cells; Other: placebo suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT00669227

SCAMI 01-04

Details and patient eligibility

About

Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo. The study includes an integrated pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size will be calculated. The primary endpoint is the improvement in left ventricular ejection fraction with an assumed 2.5% higher improvement in the cell treated population compared to the placebo treated group.

Full description

There is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. Patients will be stratified according to age, localization of myocardial infarction and left ventricular function.

Enrollment: 42 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• acute myocardial infarction with time to revascularization >6 hours from symptom start
• clear target vessel
• large myocardial infarction defined as: proximal vessel occlusion, CK > 1000 U/L, myocardial scar in magnetic resonance imaging > 10% of left ventricular muscle mass
• potential prior thrombolysis
• written informed consent

Exclusion criteria

• acute myocardial infarction with revascularization within 6 hours after symptom start
• prior myocardial infarction
• no clear target vessel
• contraindication for magnetic resonance imaging (e.g. pacemaker, ICD)
• severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging)
• prior hematologic disease
• prior chemo therapy
• prior stem cell transplantation
• prior treatment with G-CSF
• known alteration of the bone marrow by alcohol or drugs, e.g. agranulocytosis
• local infection of puncture sites

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

autologous stem cells, Ficoll preparation, intracoronary administration at the same day of bone marrow cell aspiration

Treatment:

Other: autologous stem cells

2

Placebo Comparator group

Description:

placebo is visually indistinguishable from verum due to integration of autologous erythrocytes, intracoronary administration the same day of bone marrow aspiration

Treatment:

Other: placebo suspension