Table 4.
Adjudicated Clinical and Safety Outcomes
| Lead-In (n = 6) |
Allo-MSC (n = 14) |
Placebo (n = 17) |
||||
|---|---|---|---|---|---|---|
| SPI to 6 Months | 6 Months to 12 Months | SPI to 6 Months | 6 Months to 12 Months | SPI to 6 Months | 6 Months to 12 Months | |
| Major adverse cardiac events | ||||||
| Deaths (cardiovascular) | 0 | 0 | 0 | 1 | 0 | 0 |
| Hospitalization for worsening HF | 0 | 1 | 1 | 0 | 2∗ | 3∗ |
| Other exacerbation of HF (nonhospitalization) | 0 | 0 | 0 | 0 | 0 | 1 |
| Other significant clinical events | ||||||
| Nonfatal stroke | 0 | 0 | 0 | 0 | 0 | 0 |
| Nonfatal myocardial infarction | 0 | 0 | 0 | 0 | 0 | 0 |
| Coronary artery revascularization | 0 | 0 | 0 | 0 | 0 | 0 |
| Ventricular tachycardia/fibrillation | 0 | 0 | 0 | 0 | 0 | 0 |
| Pericardial tamponade | 0 | 0 | 0 | 0 | 0 | 0 |
| Infectious myocarditis | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypersensitivity reaction | 0 | 0 | 0 | 0 | 0 | 1 |
| Neoplasm | 0 | 0 | 0 | 0 | 0 | 0 |
| Total participants | 0 | 1 | 1 | 1 | 1∗ | 2∗ |
Values are n.
Allo-MSC = allogeneic mesenchymal stromal cells; HF = heart failure; SPI = study product injection.
∗
Includes multiple events in a participant during this time period.