Congestive Heart Failure Clinical Trial
Official title:
Feasibility Study of Retrograde Delivery of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Patients Diagnosed With Congestive Heart Failure (CHF)
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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