Cell Therapy for Coronary Heart Disease

Status Terminated

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00289822
Study type	Interventional
Source	Johann Wolfgang Goethe University Hospitals
Contact
Status	Terminated
Phase	Phase 2
Start date	January 2002
Completion date	January 2005

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.