Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy (Alster-Star)

Kai Jaquet, PhD, DSc

Status

Terminated

Conditions

Heart Disease

Treatments

Procedure: Intramyocardial Cell therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT01144221

1764

2008-008368-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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