Table 7.

Study Endpoints

Feasibility assessment (the following measures will be reported)
Number and percent of patients who have: Events between randomization and study product injection (SPI) that preclude the procedure Failed bone marrow aspiration procedure Failed endomyocardial biopsy procedure Failed release criteria (including minimum number of cells) for receiving the MSC product Failed release criteria (including minimum number of cells) for receiving the CPC product Less than 15 injections during the SPI procedure At least one cardiac MRI endpoint measure that is uninterpretable due to issues related to the device, including, but not limited to, inability to undergo the procedure
Safety assessment (assessed from baseline to 6 months and from baseline to 12 months)
Major Adverse Cardiac Events (HF MACE) Death Hospitalization for worsening heart failure Exacerbation of heart failure (not requiring hospitalization)
Other Significant Clinical Events Non-fatal stroke Non-fatal myocardial infarction Coronary artery revascularization Ventricular tachycardia/fibrillation Pericardial tamponade
All adverse events at least grade 2 in severity (Common Terminology Criteria for Adverse Events)
Prospectively declared efficacy endpoint measures: (assessed from baseline to 6 months and from baseline to 12 months)
Myocardial Function and Structure (cardiac MRI) Function: Change in LV ejection fraction, global strain, and regional strain Structure: Change in LV end-diastolic and end-systolic volume indices and LV sphericity index Morphology: Change in infarct/scar volume
Functional Capacity Change in VO2 max (treadmill) Change in exercise tolerance (6-minute walk test) Change in MLHF Questionnaire score
Clinical Outcomes MACE Cumulative days alive and out of hospital
Biomarkers Change in NT-proBNP