Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy

Study Overview
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Brief Summary
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This is an evaluative, monocentric study in patients with chronic ischemic heart disease and left bundle branch block who received an ICD-CRT. It is an early investigation on the safety and effects of a single administration of bone marrow derived mononuclear cells after implantation of an ICD-CRT device as an adjunct to CRT and usual drug treatment.

Official Title
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Protocol on an Evaluative Study on Bone Marrow Derived Mononuclear Cells for Optimization of Biventricular Pacing in Patients With Chronic Ischemic Left Ventricular Dysfunction

Conditions
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Heart Disease

Intervention / Treatment
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* Procedure: Intramyocardial Cell therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic left ventricular dysfunction (ejection fraction <35 %) in chronic ischemic heart disease and asynchronic contraction with indication for a biventricular stimulation (CRT, chronic resynchronization therapy), who do not have an improvement of >15% of LVEF 3 months after CRT-device implantation wall motion dysfunction of any territory left bundle branch block Patients were on individual optimal treatment for chronic ischemic heart disease with one or a combination of the following drug types: diuretics, ß-blockers, ACE-inhibitors, AT1 blockers and/or lipid lowering agents for at least 30 days before CRT Implantation Exclusion Criteria: patients with left ventricular dysfunction due to other reasons than ischemic cardiomyopathy, e.g. hypertension, dilatative cardiomyopathy with relevant valvular disease; Aneurysma of the anterior myocardial wall or myocardial wall thickness of < 5 mm, with overt heart failure, other than ischemic cardiomyopathy, with history of stroke and/or transient ischemic attack (TIA), with history of thromboembolic event (e.g. phlebothrombosis, pulmonary embolism), bleeding disorders and known disease of the coagulation system; with extensive deviations of baseline laboratory values and significant findings at physical examination which in the opinion of the investigator may worsen under treatment; with severe systemic disease - (e.g. known or suspected anaphylaxia, intolerance against X-ray or contrast agent and, pre-malignant and malignant disease) atrial fibrillation with average heart rate >70 bpm pregnant women and women of childbearing potential who have not had a negative pregnancy test within 48 hours before treatment; with any disease or condition that seriously compromises the function of other body systems than the heart and/or might interfere with conduct of the study and interpretation of the results; patients with a chronic or acute HIV-, HBV-, HCV-infection; improvement of more than 15% of LVEF 3 months after CRT-device implantation patients who have a ICD Implantation for secondary prophylactic indication. These patients show a history of resuscitation, VT or syncope. patients who are currently participating in another investigational drug or device study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem cell treatment<br>Patients treated via stem cell injection | Procedure: Intramyocardial Cell therapy<br>* Intramyocardial Cell therapy in patients with chronic ischemic heart disease after ICD CRT Implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVEF Value | LVEF values will be compared after ICD CRT-Implantation and after Bone Marrow Derived Mononuclear Cells Injection | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Ischemic Heart Disease