Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy

NCT ID: NCT01144221

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2015-02-28

Brief Summary

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.

Conditions

Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stem cell treatment

Patients treated via stem cell injection

Group Type: EXPERIMENTAL

Intramyocardial Cell therapy

Intervention Type: PROCEDURE

Intramyocardial Cell therapy in patients with chronic ischemic heart disease after ICD CRT Implantation

Interventions

Intramyocardial Cell therapy

Intramyocardial Cell therapy in patients with chronic ischemic heart disease after ICD CRT Implantation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kai Jaquet, PhD, DSc

INDUSTRY

Sponsor Role: lead

Responsible Party

Kai Jaquet, PhD, DSc

Head of Stem Cell Lab

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Korff Krause, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Asklepios proresearch

Locations

Asklepios Clinic St. Georg

Hamburg, , Germany

Countries

Germany

Other Identifiers

2008-008368-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1764

Identifier Type: -

Identifier Source: org_study_id