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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01144221
Recruitment Status : Terminated (funding issues)
First Posted : June 15, 2010
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Kai Jaquet, PhD, DSc, Asklepios proresearch

Tracking Information
First Submitted Date  ICMJE June 14, 2010
First Posted Date  ICMJE June 15, 2010
Last Update Posted Date April 9, 2018
Actual Study Start Date  ICMJE May 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2010)
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
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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  ICMJE Experimental: Stem cell treatment
Patients treated via stem cell injection
Intervention: Procedure: Intramyocardial Cell therapy
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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 5, 2018)
6
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2010)
20
Actual Study Completion Date  ICMJE February 2015
Actual 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kai Jaquet, PhD, DSc, Asklepios proresearch
Study Sponsor  ICMJE Kai Jaquet, PhD, DSc
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