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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Disease Procedure: Intramyocardial Cell therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : May 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Stem cell treatment
Patients treated via stem cell injection
 Procedure: Intramyocardial Cell therapy
Intramyocardial Cell therapy in patients with chronic ischemic heart disease after ICD CRT Implantation


Outcome Measures
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Primary Outcome Measures :
  1. LVEF Value [ Time Frame: 12 months ]
    LVEF values will be compared after ICD CRT-Implantation and after Bone Marrow Derived Mononuclear Cells Injection


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144221


Locations
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Germany
Asklepios Clinic St. Georg
Hamburg, Germany, 20099
Sponsors and Collaborators
Kai Jaquet, PhD, DSc
Investigators
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Principal Investigator: Korff Krause, Dr. med. Asklepios proresearch
More Information
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Responsible Party: Kai Jaquet, PhD, DSc, Head of Stem Cell Lab, Asklepios proresearch
ClinicalTrials.gov Identifier: NCT01144221    
Other Study ID Numbers: 1764
2008-008368-28 ( EudraCT Number )
First Posted: June 15, 2010    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: August 2012
Keywords provided by Kai Jaquet, PhD, DSc, Asklepios proresearch:
Chronic Ischemic Heart Disease
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases