This is a dose-ranging clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture expanded, nucleated, allogeneic MPCs in subjects who have cardiomyopathy of both ischemic and idiopathic etiology.
Heart failure subjects recruited will include those who have advanced heart failure NYHA (New York Heart Association) class II to IV and a depressed ejection fraction (EF \< 40%). Baseline eligibility testing assessments will be completed within 28 days prior to cell delivery. Efficacy will be explored at 3, 6, and 12 months. This will be a single-blinded, dose-escalation, cohort study in 60 subjects allocated sequentially to 1 of 3 cohorts A, B, or C. Forty-five subjects will be randomized to receive transendocardial delivery of MPC treatment, and 15 subjects will be randomized to receive standard-of-care treatment without MPC administration. The fifteen subjects randomized to receive standard of care without needle injection will serve as the study's control population and will undergo mock mapping and verbal injection scripts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
25 M allogeneic MPCs by transendocardial injection and mapping.
75 M allogeneic MPCs by transendocardial injection and mapping.
150 M allogeneic MPCs by transendocardial injection
Mercy Gilbert Medical Center
Gilbert, Arizona, United States
University of California, San Diego
La Jolla, California, United States
Minneapolis Heart Institute 920 East 28th St, Suite 300
Minneapolis, Minnesota, United States
UPMC
Pittsburgh, Pennsylvania, United States
The primary objective of this study is to evaluate the feasibility and safety of transendocardial injection using mapping Catheter with the Left Ventricular Injection Catheter of 25 M, 75 M, and 150 M allogeneic MPCs in subjects with heart failure.
Time frame: 3 years
The secondary objectives are to explore functional efficacy for subsequent study design.
Time frame: 3 years
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Mock
Texas Heart Institue
Houston, Texas, United States
Swedish Heart and Vascular Institute
Seattle, Washington, United States