The primary objective of this feasibility study is to provide clinical data to demonstrate the safety and activity of a concentrate of nucleated cells from bone marrow aspirate (BMAC) produced with the Harvest Bone Marrow Aspirate Concentrate System for treating patients diagnosed with congestive heart failure (CHF).
To demonstrate that the infusion of bone marrow nucleated cells into the coronary sinus is safe as assessed by adverse event records. To assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina and heart failure as measured by QOL questionnaire, Minnesota Living with Heart Failure, NYHA and CCS classification and SPECT. To assess the effect of the infusion of bone marrow nucleated cells on heart function as measured by ejection fraction (EF) and left ventricular end-diastolic diameter (LVEDD) by ECHO. To assess the effect of the infusion of bone marrow nucleated cells on the area of ischemia as measured by myocardial SPECT studies and ECHO.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Infusion of 60 mL of Bone Marrow Aspirate Concentrate
Rostock University Hospital
Rostock, Germany
Medanta the Medicity
Gūrgaon, India
Dept of Cardiology, Clinicas Maison de Sante
Lima, Peru
Number of participants with adverse events as a measure of safety and tolerability
To demonstrate that the infusion of bone marrow nucleated cells into the coronary sinus is safe as assessed by adverse event records.
Time frame: 12 Months
Assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina
To assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina as measured by QOL questionnaire, Minnesota Living with Heart Failure, NYHA and CCS classification and SPECT.
Time frame: 12 Months
Assess the effect of the infusion of bone marrow nucleated cells on the clinical course of heart failure
To assess the effect of the infusion of bone marrow nucleated cells on the clinical course of heart failure as measured by QOL questionnaire, Minnesota Living with Heart Failure, NYHA and CCS classification and SPECT.
Time frame: 12 Months
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