Cell Therapy for Coronary Heart Disease

Sponsor

Johann Wolfgang Goethe University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00289822

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jan 1, 2002

Study Completion Date :

Jan 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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