Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy (Alster-Star)
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ClinicalTrials.gov Identifier: NCT01144221 |
Recruitment Status :
Terminated
(funding issues)
First Posted : June 15, 2010
Last Update Posted : April 9, 2018
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Sponsor:
Kai Jaquet, PhD, DSc
Information provided by (Responsible Party):
Kai Jaquet, PhD, DSc, Asklepios proresearch
Tracking Information | ||||
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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 |
LVEF Value [ Time Frame: 12 months ] LVEF values will be compared after ICD CRT-Implantation and after Bone Marrow Derived Mononuclear Cells Injection
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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 |
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Condition ICMJE | Heart Disease | |||
Intervention ICMJE | Procedure: Intramyocardial Cell therapy
Intramyocardial Cell therapy in patients with chronic ischemic heart disease after ICD CRT Implantation
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Study Arms ICMJE | Experimental: Stem cell treatment
Patients treated via stem cell injection
Intervention: Procedure: Intramyocardial Cell therapy
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
6 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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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 |
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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 |