Clinical trial evaluating the safety and efficacy of intracoronary administration of MYDICAR (AAV1/SERCA2a) in subjects with heart failure

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Study title: 
Clinical trial evaluating the safety and efficacy of intracoronary administration of MYDICAR (AAV1/SERCA2a) in subjects with heart failure
Long title: 
A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart Failure (CUPID Phase 2b Trial)
EU record number: 
B/BE/12/BVW2
EudraCT number: 
2012-001700-37
Pharmaceutical study code: 
CELL-004
Company / Sponsor: 
Celladon
Phase: 
IIb
Treated organism: 
Humans
Indication category: 
Cardiovascular therapy
Disease: 
Heart failure
Therapeutic approach: 
Gene therapy
Genetic modification: 
Human SERCA2a:CA++ pump involved in the regulation of heart contraction/relaxation cycle
Method of transfer of nucleic acid of interest: 
Adeno-associated virus serotype 1
Administered biological material: 
Recombinant AAV1
Route of administration: 
intracoronary
Locations in Belgium: 
Aalst, Brussels, Leuven
Nr of subjects: 
200 worldwide, 15 in Belgium
Foreseen duration: 
2 years
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

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