Table 1.
Transgene | SDF-1 | SDF-1 | SERCA2a | SERCA2a | AC6 |
---|---|---|---|---|---|
Trial Identifier | NCT01082094 | NCT01643590 | NCT00454818 | NCT01643330 | NCT00787059 |
Phase | 1 | 2 | 1 and 2 | 2 | 1/2 |
Vector | plasmid | plasmid | AAV1 | AAV1 | Adenovirus |
Delivery Method | Endomycardial injection | Endomycardial injection | Intracoronary injection | Intracoronary injection | Intracoronary injection |
Enrollment | 17 | 90 | 39 | 200 | 72 |
Sample Size | 5 mg dose: 4 15 mg dose: 6 30 mg dose: 7 |
Placebo: 30 15 mg dose: 30 30 mg dose: 30 |
Placebo: 14 Low dose: 8 Middle dose: 8 High dose: 9 |
Placebo: 100 Treatment: 100 |
Placebo: 18 Treatment: 54 in 6 doses |
Design | Open label | Randomized Double-blind Placebo-controlled |
Randomized Double-blind Placebo-controlled |
Randomized Double-blind Placebo-controlled |
Randomized Double-blind Placebo-controlled |
Status | Completed | Recruiting | Completed | Recruiting | Recruiting |
Outcome | Apparently safe; Trends in improving symptoms and functions |
N/A | Apparently safe; Trends in improving symptoms and functions |
N/A | N/A |