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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014