Cell Therapy for Coronary Heart Disease

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00289822
• Other study ID #: 158/02
• Status: Terminated
• Phase: Phase 2
• First received: February 8, 2006
• Last updated: November 29, 2006
• Start date: January 2002
• Est. completion date: January 2005

Study information

• Verified date: February 2006
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• intracoronary infusion of progenitor cells

Locations

Country	Name	City	State
Germany	J. W. Goethe University Hospitals	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Assmus B, Honold J, Schächinger V, Britten MB, Fischer-Rasokat U, Lehmann R, Teupe C, Pistorius K, Martin H, Abolmaali ND, Tonn T, Dimmeler S, Zeiher AM. Transcoronary transplantation of progenitor cells after myocardial infarction. N Engl J Med. 2006 Sep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in global left ventricular function (measured by quantitative left ventricular angiography)
Secondary	Quantitative parameters of regional left ventricular function of the target area
Secondary	changes in left ventricular volumes
Secondary	functional status as assessed by NYHA classification
Secondary	event-free survival after 4 months follow-up