Add a fibrin gel embedding hESCs-derived CD15+ Isl-1+ progenitors in addition to CABG and/or a mitral valve procedure
Plan to measure feasibility of patch’s generation and its efficacy on cardiac functions
Within 1 year
To record clinical/biological abnormalities including arrhythmias
PERSERVATION (NCT01226563)
IK-5001 (an injectable, bioabsorbable scaffold)
To test the feasibility of intracoronary delivery bioabsorbable scaffold to prevent adverse left ventricular remodeling and dysfunction
27 patients Age 54 ± 9 years
Moderate-to-large MI
Minnesota Score LVEF NT-proBNP 2977 ± 5392
To place an infusion catheter immediately distal to the deployed stent and 2 ml IK-5001 was injected into the IRA
At the end point (180 days) of observation Minnesota Score 16 ± 3 ( compared with day 30) NT-proBNP 566 ± 847 ()
180 days
No significant ventricular arrhythmia was observed; None of adverse events were judged to be related to the device
AUGMENT-HF (NCT00847964)
Algisyl-LVR (self-gelling alginate hydrogel)
To measure a tissue engineering strategy to increase wall thickness and reduce chamber diameter
6 patients
Dilated cardiomyopathy
LVEF 28.7 ± 8.5% LVEDV 139.5 ± 20.6 ml LVESV 99.8 ± 25.8 ml KCCQ score 39.4 ± 28.0 Number of patients in NYHA class III/IV: 6
All the patients received left ventricular restoration with 10–15 implants of Algisyl-LVR concomitant with coronary artery bypass or valve surgery
LVEF 36.0 ± 13.5% LVEDV 123.6 ± 18.6 ml LVESV 77.2 ± 29.5 ml KCCQ score 74.0 ± 25.0 () No. of patients in NYHA class III/IV: 1
3 months
No significant cardiac adverse events were recorded
MI: myocardial infraction; LVEF: left ventricular ejection fraction; LVEDV: left ventricular end diastolic volume; LVESV: left ventricular end systolic volume; VSD: ventricular defect defect; NHYA FC: New York Heart Association functional classification; LVFDT: left ventricular filling deceleration time; IRA: infract-related artery; KCCQ: Kansas City Cardiomyopathy Questionnaire.