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Cell Therapy for Coronary Heart Disease

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. Identifier: NCT00289822
Recruitment Status : Terminated
First Posted : February 10, 2006
Last Update Posted : November 30, 2006
Information provided by:
Johann Wolfgang Goethe University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Coronary Artery Disease Drug: intracoronary infusion of progenitor cells Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2002
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in global left ventricular function (measured by quantitative left ventricular angiography)

Secondary Outcome Measures :
  1. Quantitative parameters of regional left ventricular function of the target area
  2. changes in left ventricular volumes
  3. functional status as assessed by NYHA classification
  4. event-free survival after 4 months follow-up

Information from the National Library of Medicine

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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

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

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 identifier (NCT number): NCT00289822

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J. W. Goethe University Hospitals
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
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Principal Investigator: Andreas M Zeiher, MD J. W. Goethe University Hospitals
Study Director: Volker Schaechinger, MD J. W. Goethe University Hospitals
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00289822    
Other Study ID Numbers: 158/02
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: November 30, 2006
Last Verified: February 2006
Keywords provided by Johann Wolfgang Goethe University Hospital:
chronic heart failure
myocardial infarction
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases