Cell Therapy for Coronary Heart Disease

Phase 2

Terminated

• Conditions: Coronary Artery Disease

• Registration Number: NCT00289822
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2002-01
• Study Completion: 2005-01
• Status Verified: 2006-02
• Study First Submitted: 2006-02-08
• Study First Submitted QC: 2006-02-08
• Study First Posted: 2006-02-10
• Last Update Submitted: 2006-11-29
• Last Update Posted: 2006-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

J. W. Goethe University Hospitals; 🇩🇪 Frankfurt, Germany