After myocardial infarction patients suffer from insufficient blood and oxygen supply. This often results in a reduced heart function attributed to irreversible loss of viable cardiomyocytes. The aim of the study is to determine whether injection of the patient’s own bone marrow stem cells yields an additional benefit to coronary artery bypass graft (CABG) surgery.

• Conditions: Coronary artery disease after myocardial infarction with an indication for CABG surgery; MedDRA version: 18.0Level: PTClassification code 10028596Term: Myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2006-006404-11-DE
• Lead Sponsor: Miltenyi Biotec GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-30
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. Coronary artery disease after myocardial infarction with indication for CABG surgery
2. Currently reduced global LVEF assessed at site by cardiac MRI at rest (25% = LVEF = 50%)
3. Presence of a localized akinetic/hypokinetic/hypoperfused area of LV myocardium for defining the target area
4. Informed consent of the patient
5.18 years = Age < 80 years
6. Are not pregnant and do not plan to become pregnant during the study. Females with childbearing potential must provide a negative pregnancy test within 1-7 days before OP and must be using oral or injectable contraception (non childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before study start).

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 142
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 142

Exclusion Criteria

Patients will be entered into this study only if they meet none of the following criteria:
1. Emergency operation
2. Presence of any moderate-severe valvular heart disease requiring concomitant valve replacement or reconstruction
3. Medical History of recent resuscitation in combination with ventricular arrhythmia classified by LOWN = class II
4. Acute myocardial infarction within last 2 weeks
5. Debilitating other disease: Degenerative neurologic disorders, psychiatric disease, terminal renal failure requiring dialysis, previous organ transplantation, active malignant neoplasia, or any other serious medical condition that, in the opinion of the investigator is likely to alter the patient’s course of recovery or the evaluation of the study medication’s safety
6. Impaired ability to comprehend the study information
7. Absence of written informed consent
8. Treatment with any investigational drug within the previous 30 days
9. Apparent infection (c-reactive protein [CRP] = 20 mg/L, fever = 38.5°C)
10. Contraindication for MRI scan
11. Immune compromise including active infection with Hepatitis B, C, HIV virus or seropositivity for Treponema pallidum
12. Pregnant or breast feeding
13. Childbearing potential with unreliable birth control methods
14. Have previously been enrolled in this study, respectively phase I and phase II
15. Known hypersensitivity or sensitization against murine products and human-anti-mouse-antibody-titer = 1:1000.
16. Contraindication to bone marrow aspiration
17. Known hypersensitivity against iron dextrane

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified