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.

INTRAMYOCARDIAL TRANSPLANTATION OF BONE MARROW STEM CELLS FOR IMPROVEMENT OF POST-INFARCT MYOCARDIAL REGENERATION IN ADDITION TO CABG SURGERY: a controlled prospective, randomized, double blinded multicenter trial - PERFECT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006404-11-DE

Enrollment

142

Registered

2007-08-30

Start date

2008-03-19

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease after myocardial infarction with an indication for CABG surgery MedDRA version: 18.0 Level: PT Classification code 10028596 Term: Myocardial infarction System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: CD133+ autologous bone marrow stem cells Pharmaceutical Form: Suspension for injection in pre-filled syringe Other descriptive name: CD133+ enriched bone marrow stem cells Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 142

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether injection of autologously derived bone marrow stem cells yields a functional benefit in addition to the coronary artery bypass graft (CABG) operation as determined by left ventricular heart function (LVEF-MRI);Secondary Objective: To determine the effects of an injection of autologously derived bone marrow stem cells on physical exercise capacity, cardiac function, safety and quality of life (QoL);Primary end point(s): The primary endpoint is LVEF at 6 months postoperatively, measured by MRI at rest. Cardiac MRI is established as the gold standard for determination of LV function (LVEF and LV volumes).;Timepoint(s) of evaluation of this end point: At 6 months postoperatively	—

Measure

Time frame

Main Objective: To determine whether injection of autologously derived bone marrow stem cells yields a functional benefit in addition to the coronary artery bypass graft (CABG) operation as determined by left ventricular heart function (LVEF-MRI);Secondary Objective: To determine the effects of an injection of autologously derived bone marrow stem cells on physical exercise capacity, cardiac function, safety and quality of life (QoL);Primary end point(s): The primary endpoint is LVEF at 6 months postoperatively, measured by MRI at rest. Cardiac MRI is established as the gold standard for determination of LV function (LVEF and LV volumes).;Timepoint(s) of evaluation of this end point: At 6 months postoperatively

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change in LVEF at 6 months post-OP compared with preoperatively (screening) and early postoperatively (discharge) as assessed by MRI and echocardiography. 2. Change in LV dimensions (left ventricular end systolic dimension [LVESD], left ventricular end diastolic dimension [LVEDD]) at 6 month post-OP compared with preoperatively (screening) and early postoperatively (discharge) as assessed by echocardiography. 3. Change in physical exercise capacity determined by 6 minute walk test at 6 months post-OP compared with preoperatively (screening) and early postoperatively (discharge). 4. Change in NYHA and CCS class at 6 months post-OP compared with preoperatively (screening) and early postoperatively (discharge). 5. MACE (cardiac death, myocardial infarction, secondary intervention/reoperation, ventricular arrhythmia). 6. QoL-score at 6 months post-OP compared with preoperatively (screening) and 3 months (telephone). ;Timepoint(s) of evaluation of this end point: Early postoperatively (hospital discharge) At 3 months postoperatively At 6 months postoperatively	—

Measure

Time frame

Secondary end point(s): 1. Change in LVEF at 6 months post-OP compared with preoperatively (screening) and early postoperatively (discharge) as assessed by MRI and echocardiography. 2. Change in LV dimensions (left ventricular end systolic dimension [LVESD], left ventricular end diastolic dimension [LVEDD]) at 6 month post-OP compared with preoperatively (screening) and early postoperatively (discharge) as assessed by echocardiography. 3. Change in physical exercise capacity determined by 6 minute walk test at 6 months post-OP compared with preoperatively (screening) and early postoperatively (discharge). 4. Change in NYHA and CCS class at 6 months post-OP compared with preoperatively (screening) and early postoperatively (discharge). 5. MACE (cardiac death, myocardial infarction, secondary intervention/reoperation, ventricular arrhythmia). 6. QoL-score at 6 months post-OP compared with preoperatively (screening) and 3 months (telephone). ;Timepoint(s) of evaluation of this end point: Early postoperatively (hospital discharge) At 3 months postoperatively At 6 months postoperatively

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Countries

Germany

Contacts

Public ContactClinical Trials Information

Miltenyi Biotec GmbH

petrah@miltenyibiotec.de

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026