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. Author manuscript; available in PMC: 2014 Apr 1.
Published in final edited form as: Transl Res. 2012 Dec 20;161(4):313–320. doi: 10.1016/j.trsl.2012.11.004

Table 1.

Clinical Trials Using Cardiac Gene Transfer for CHF

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