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

This study is currently recruiting participants.
Verified August 2012 by Asklepios proresearch
Sponsor:
Information provided by:
Asklepios proresearch
ClinicalTrials.gov Identifier:
NCT01144221
First received: June 14, 2010
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Heart Disease
Procedure: Intramyocardial Cell therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Protocol on an Evaluative Study on Bone Marrow Derived Mononuclear Cells for Optimization of Biventricular Pacing in Patients With Chronic Ischemic Left Ventricular Dysfunction

Resource links provided by NLM:


Further study details as provided by Asklepios proresearch:

Primary Outcome Measures:
  • LVEF Value [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    LVEF values will be compared after ICD CRT-Implantation and after Bone Marrow Derived Mononuclear Cells Injection


Estimated Enrollment: 20
Study Start Date: May 2010
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Intramyocardial Cell therapy
    Intramyocardial Cell therapy in patients with chronic ischemic heart disease after ICD CRT Implantation
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144221

Locations
Germany
Asklepios Clinic St. Georg Recruiting
Hamburg, Germany, 20099
Contact: Korff Krause, Dr. med.    0049-40-181885 ext 4493      
Principal Investigator: Korff Krause, Dr. med.         
Sponsors and Collaborators
Asklepios proresearch
Investigators
Principal Investigator: Korff Krause, Dr. med. Asklepios proresearch
  More Information

No publications provided

Responsible Party: Asklepios proresearch
ClinicalTrials.gov Identifier: NCT01144221     History of Changes
Other Study ID Numbers: 1764, 2008-008368-28
Study First Received: June 14, 2010
Last Updated: August 10, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Asklepios proresearch:
Chronic Ischemic Heart Disease

Additional relevant MeSH terms:
Heart Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014