This study will assess the safety and efficacy of intracoronary artery administered autologous bone marrow derived stem cells in subjects post ST segment elevation myocardial infarction (STEMI). This will be assessed by evaluating and comparing the autologous stem cell treatment group to the control group in terms of the occurrence of AE's, SAE's and Major Adverse Cardiac Events (MACE), by the change in myocardial perfusion (RTSS) measured quantitatively by gated single photon emission computed tomography myocardial perfusion imaging (gated SPECT MPI), and other secondary endpoints such as LVEF measured by cardiac MRI in addition to other endpoints.
Efficacy endpoint is at 6 months. Clinical endpoints and safety will be measured through 36 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
195
dosage = 10 or more million CD34+ cells via intracoronary infusion
matching placebo
University of Alabama Birmingham
Birmingham, Alabama, United States
Heart Center Research, LLC (Huntsville Hospital)
Huntsville, Alabama, United States
Mercy Gilbert Medical Group
Gilbert, Arizona, United States
Mayo Clinic - Arizona
Phoenix, Arizona, United States
Scripps-La Jolla, CA
La Jolla, California, United States
To determine safety and efficacy of intracoronary infusion of NBS10.
The primary endpoint includes the occurrence of AE's, SAE's and Major Adverse Cardiac Events (MACE) and the assessment of myocardial perfusion measured by quantitative gated SPECT MPI specifically looking at resting total severity score.
Time frame: primary outcome measured at 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Keck School of Medicine - University of Southern California
Los Angeles, California, United States
St.Johns Regional Hospital and Medical Center
Oxnard, California, United States
Standford University School of Medicine
Stanford, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida-Gainesville
Gainesville, Florida, United States
...and 48 more locations