Intramyocardial Transplantation of Bone Marrow Stem Cells in Addition to Coronary Artery Bypass Graft (CABG) Surgery

• Status: Terminated
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

In spite of the fact that the post-myocardial infarction survival rate has improved with recent medical advances, reduced heart function attributed to irreversible loss of viable cardiomyocytes is still a major clinical problem.

The aim of the current study is to determine whether intramyocardial injection of autologous CD133+ bone marrow stem cells yields a functional benefit in addition to coronary artery bypass graft (CABG) surgery in patients with chronic ischemic coronary artery disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Miltenyi Biotec B.V. & Co. KG; Miltenyi Biotec GmbH
• Collaborator: German Federal Ministry of Education and Research

Criteria

Inclusion Criteria:

• Coronary artery disease after myocardial infarction with indication for CABG surgery

• Currently reduced global LVEF assessed at site by cardiac MRI at rest (25% ≤ LVEF ≤ 50%)

• Presence of a localized akinetic/hypokinetic/hypoperfused area of LV myocardium for defining the target area

• Informed consent of the patient

• 18 years ≤ Age < 80 years

• 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).

Exclusion Criteria:

• Emergency operation

• Presence of any moderate-severe valvular heart disease requiring concomitant valve replacement or reconstruction

• Medical History of recent resuscitation in combination with ventricular arrhythmia classified by LOWN ≥ class II

• Acute myocardial infarction within last 2 weeks

• 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

• Impaired ability to comprehend the study information

• Absent informed written consent

• Treatment with any investigational drug within the previous 30 days

• Apparent infection (c-reactive protein [CRP] ≥ 20 mg/L, fever ≥ 38.5° C)

• Contraindication for MRI scan

• Immune compromise including active infection with Hepatitis B, C, HIV virus or seropositivity for Treponema pallidum

• Pregnant or breast feeding

• Childbearing potential with unreliable birth control methods

• Have previously been enrolled in this study, respectively phase I and phase II

• Known hypersensitivity or sensitization against murine products and human-anti-mouse-antibody-titer ≥ 1:1000

• Contraindication to bone marrow aspiration

• Known hypersensitivity against iron dextran