Progenitor Cell Therapy in Dilative Cardiomyopathy
Transplantation Of Progenitor Cells And Recovery Of Left Ventricular Function In Patients With Nonischemic Dilatative Cardiomyopathy
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
Intracoronary infusion of bone marrow derived progenitor cells into the LAD in patients with non ischemic dilated cardiomyopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2004
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 31, 2006
CompletedFirst Posted
Study publicly available on registry
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFebruary 18, 2009
February 1, 2009
4.7 years
January 31, 2006
February 17, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
LV function (Ejection fraction within 3 months) Simpson
4 months
Interventions
catheter delivery of stem cells
Eligibility Criteria
You may qualify if:
- Age 8-80
- Dilated Cardiomyopathy, Ejection fraction \< 40%
- LVEDD \> 60mm
- Stable clinical condition within last 6 months
- Written informed consent
You may not qualify if:
- Myocardial infarction or coronary intervention in the past
- Change of medical therapy within the last 6 weeks prior to cell therapy
- Tumor within last 5 years or incomplete remission
- Active infection
- Active bleeding
- Stroke within last 2 years
- Surgery or trauma within last 2 months
- Uncontrolled hypertension
- HIV infection
- Chronic inflammatory disease
- Liver disease (GOT \> 2x upper normal limit)
- Renal dysfunction (creatinin \> 2.0mg/dl)
- Thrombopenia \< 100.000
- Anemia (hemoglobin \< 8.5 g/dl)
- Mental retardation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
De Rosa S, Seeger FH, Honold J, Fischer-Rasokat U, Lehmann R, Fichtlscherer S, Schachinger V, Dimmeler S, Zeiher AM, Assmus B. Procedural safety and predictors of acute outcome of intracoronary administration of progenitor cells in 775 consecutive procedures performed for acute myocardial infarction or chronic heart failure. Circ Cardiovasc Interv. 2013 Feb;6(1):44-51. doi: 10.1161/CIRCINTERVENTIONS.112.971705. Epub 2013 Jan 29.
PMID: 23362308DERIVEDLeistner DM, Seeger FH, Fischer A, Roxe T, Klotsche J, Iekushi K, Seeger T, Assmus B, Honold J, Karakas M, Badenhoop K, Frantz S, Dimmeler S, Zeiher AM. Elevated levels of the mediator of catabolic bone remodeling RANKL in the bone marrow environment link chronic heart failure with osteoporosis. Circ Heart Fail. 2012 Nov;5(6):769-77. doi: 10.1161/CIRCHEARTFAILURE.111.966093. Epub 2012 Aug 30.
PMID: 22936827DERIVEDXu Q, Seeger FH, Castillo J, Iekushi K, Boon RA, Farcas R, Manavski Y, Li YG, Assmus B, Zeiher AM, Dimmeler S. Micro-RNA-34a contributes to the impaired function of bone marrow-derived mononuclear cells from patients with cardiovascular disease. J Am Coll Cardiol. 2012 Jun 5;59(23):2107-17. doi: 10.1016/j.jacc.2012.02.033.
PMID: 22651868DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas M Zeiher
Div. of Cardiology, University of Frankfurt, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 31, 2006
First Posted
February 1, 2006
Study Start
May 1, 2004
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
February 18, 2009
Record last verified: 2009-02