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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2012 by Asklepios proresearch.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Asklepios proresearch

ClinicalTrials.gov Identifier:

NCT01144221

First received: June 14, 2010

Last updated: August 10, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 14, 2010

Last Updated Date

August 10, 2012

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

May 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

LVEF Value [ Time Frame: 12 months ]

LVEF values will be compared after ICD CRT-Implantation and after Bone Marrow Derived Mononuclear Cells Injection

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01144221 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Heart Disease

Intervention ^ICMJE

Procedure: Intramyocardial Cell therapy

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

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

May 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01144221

Other Study ID Numbers ^ICMJE

1764
2008-008368-28 ( EudraCT Number )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Asklepios proresearch

Study Sponsor ^ICMJE

Asklepios proresearch

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Korff Krause, Dr. med.

Asklepios proresearch

PRS Account

Asklepios proresearch

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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