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
Data Collection
Arterial Occlusive Diseases+11
+ Arteriosclerosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: January 1, 2002
Actual date on which the first participant was enrolled.* 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.75 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
J. W. Goethe University Hospitals
Frankfurt, GermanyOpen J. W. Goethe University Hospitals in Google Maps