Cell Therapy for Coronary Heart Disease - Full Text View

Sponsored by:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00289822

Purpose

Impaired contractile function after a heart attack and due to coronary heart disease is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy.

The aim of the current trial is to investigate whether infusion of progenitor cells into the coronary artery supplying the most dyskinetic left ventricular area may improve left ventricular contractile function, compared to no cell infusion in the control group, in patients with old (>= 3 months) myocardial infarction.

Condition	Intervention	Phase
Coronary Artery Disease	Drug: intracoronary infusion of progenitor cells	Phase II

MedlinePlus related topics: Coronary Artery Disease Heart Attack Heart Diseases Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Cell Therapy for Coronary Heart Disease: Infusion of Autologous Ex Vivo Cultivated Endothelial Progenitor Cells (EPCs)” and Autologous Bone Marrow Progenitor Cells in Crossover Design for Improvement of Vascularization and Cardiac Function

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:

Change in global left ventricular function (measured by quantitative left ventricular angiography)

Secondary Outcome Measures:

Quantitative parameters of regional left ventricular function of the target area
changes in left ventricular volumes
functional status as assessed by NYHA classification
event-free survival after 4 months follow-up

Estimated Enrollment:	75
Study Start Date:	January 2002
Estimated Study Completion Date:	January 2005

Detailed Description:

The study is an open-label, controlled, randomized single-center trial.
Patients post myocardial infarction (>= 3 months) with a patent infarct-related artery are included.
Bone marrow-derived progenitor cells are aspirated under local anaesthesia, and after cell processing, are infused into the patent infarct-related artery during stop flow within the same day. Blood-derived progenitor cells are isolated out of 250ml peripheral venous blood, and after cell processing and 3 days culture, are infused into the patent infarct-related artery during stop flow. In addition, left ventricular angiography is performed. In the control group coronary angiography and left ventricular angiography without any intracoronary infusion are performed.
After 3 months, left ventricular angiography is repeated, and patients of the control group cross-over to active treatment with progenitor cells, whereas patients initially treated with progenitor cells cross-over to the alternate cell type.
The primary endpoint is the change in quantitative global left ventricular ejection fraction in LV angiography between the groups.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients aged 18 to 80
Patients post-myocardial infarction (> 3 months old) or with diffuse ischemic CHD
Signed informed consent

Exclusion Criteria:

Existing neoplastic disease or signs of tumor recurrence within the last 5 years
- Active infection
- Active internal bleeding
- Stroke within the past 2 years
- Surgery or trauma within the past two months
- Uncontrolled hypertension over 160/100
- Arteriovenous malformations or aneurysms
- HIV infection
- Signs of significant kidney or liver failure (creatinine > 2.0 mg/dL, GOT > 2 x upper standard value)
- Thrombopenia (< 100,000)
- Anemia (hemoglobin < 8.5 g/dL)
- Mental retardation
- Participation in another clinical study
- Women of childbearing age
- Chronic inflammatory disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289822

Locations

Germany
J. W. Goethe University Hospitals
Frankfurt, Germany, 60590

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

Investigators

Principal Investigator:	Andreas M Zeiher, MD	J. W. Goethe University Hospitals
Study Director:	Volker Schaechinger, MD	J. W. Goethe University Hospitals

More Information

Publications:

Assmus B, Honold J, Schachinger V, Britten MB, Fischer-Rasokat U, Lehmann R, Teupe C, Pistorius K, Martin H, Abolmaali ND, Tonn T, Dimmeler S, Zeiher AM. Transcoronary transplantation of progenitor cells after myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1222-32.

Study ID Numbers:	158/02
Study First Received:	February 8, 2006
Last Updated:	November 29, 2006
ClinicalTrials.gov Identifier:	NCT00289822 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Johann Wolfgang Goethe University Hospitals:

chronic heart failure
myocardial infarction

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Failure
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Arteriosclerosis
Ischemia
Neovascularization, Pathologic
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009