Stem Cell Implantation in Patients Undergoing CABG

Stopped early · Phase 1

Conditions studied: Ischemic Cardiomyopathy, Coronary Artery Disease

In brief

The primary objective of this study is to demonstrate the feasibility and safety of intra-operative, intra-myocardial injection of autologous CD133 positive bone marrow cells at the time of coronary artery bypass graft (CABG) surgery in patients with chronic ischemic cardiomyopathy. Additionally, the feasibility of producing autologous CD133+ bone marrow stem cells will be assessed. The investigators hypothesize that collection of a sufficient number of CD133+ cells through bone marrow aspiration prior to surgery, with subsequent processing and intra-myocardial injection of high purity cells following completion of CABG, will be feasible without significant adverse clinical consequences.

Key facts

Study ID

NCT01721902

Run by

Miltenyi Biotec, Inc.

People needed

23

Starts

2010-01-01

Expected to finish

2013-12-01

Last updated by the study team

2013-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Patients with ischemic heart disease manifested by Canadian class II or greater angina and/or New York Heart Association class II, III or IV exercise intolerance AND who have undergone diagnostic coronary angiography demonstrating at least 70% diameter narrowing of at least 2 major coronary arteries or branches or at least 50% diameter narrowing of the left main coronary artery.
• Left ventricular systolic dysfunction evaluated by echocardiography or LV angiography (LV ejection fraction less than or equal to 49%).
• No contraindications or exclusions (see below)
• Willingness to participate and ability to provide informed consent

You may not qualify if…

• Contraindications to magnetic resonance imaging .
• Need for emergent revascularization.
• Need for concomitant surgical procedure at the time of CABG (e.g. valve repair or replacement, aneurysm resection, etc.).
• Hemodynamically unstable patients.
• Patients with confirmed transmural myocardial infarction within 4 weeks, and/or rising cardiac biomarker proteins (i.e. troponin), and/or worsening ECG changes.
• Prior CABG surgery.
• Stroke within 1 month prior to planned CABG.
• Diagnosed with human immunodeficiency virus (HIV) or any other immune disorder or immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.)
• Organ dysfunction
• Contra-indication for bone marrow aspiration (Thrombocytopenia < 50.000 mm3, INR > 2.0, use of antiplatelet agents other than aspirin).
• Hemoglobin less than 8g/dL, white blood cell count less than 4,000/mm3, absolute neutrophil count less than 1500/mm3
• Active infection
• Myelodysplastic syndrome (MDS)
• Significant cognitive impairment
• Any condition associated with a life expectancy of less than 6 months
• Patients known allergic reaction or contraindication to any of the component of the CD133+ enriched cells
• Participation in other studies concomitant with this study
• History of severe ventricular tachy-arrythmias
• Inability or unwillingness to provide written informed consent
• Positive serum pregnancy test

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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