Review Article

Artificial Cardiac Muscle with or without the Use of Scaffolds

Table 2

Summary of clinical trials quantitative data using various scaffold in cardiac tissue engineering.

Study nameScaffoldObjectivePatientsDiagnosisPretreatment heart functionSurgical procedurePosttreatment heart functionFollow-up timeAdverse impacts

CorMatrix ECM trialCorMatrix (decellularized porcine small intestinal submucosa)To evaluate the safety of CorMatrix for intraventricular repair of mechanical complications of MI11 consecutive patients
Between July 2011 and October 2012
Age 67 ± 11 years
LV aneurysm, Ischemic VSD, MILVEF 31 ± 7%All the patients underwent patch repair using CorMatrix ECM with a running Prolene suture techniqueThe data of LVEF not provided;
No evidence of ventricular thrombus, and there were no thromboembolic events
207 ± 211 daysNo complications of CorMatrix ECM repair failure including readmission for any cardiac cause or death

MAGNUMCollagen matrixTo evaluate intrainfarct cell therapy associated with a cell-seeded collagen scaffold grafted onto infarcted ventricles15 consecutive patients
Aged 54.2 ± 3.8 years
MI with surgical indication for CABG and LV wall has postischemic scarsNHYA FC 2.3 ± 0.5
LVEF 25 ± 7%
LVEDVol 142 ± 24 ml
LVFDT 162 ± 7
3D collagen matrix seeded with the BMCs was added on top of the scarred area at the end of surgery after BMCs injected into the same areaNHYA FC 1.4 ± 0.3 ()
LVEF 33 ± 5% ()
LVEDVol 117 ± 21 ml
LVFDT 196 ± 8 ()
Blind Radioisotopic/MRI showed that 58 ± 9.3% of the cell-implanted segments improved their kinetics and viability
3 monthsNot reported

ESCORT
(NCT02057900)
Fibrin patch matrixTo assess the feasibility and safety of a transplantation of cardiac-committed progenitor cellsPatients recruiting (estimated enrollment 6 patients)Ischemic heart diseaseNHYA FC and LVEFAdd a fibrin gel embedding hESCs-derived CD15+ Isl-1+ progenitors in addition to CABG and/or a mitral valve procedurePlan to measure feasibility of patch’s generation and its efficacy on cardiac functionsWithin 1 yearTo 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 dysfunction27 patients
Age 54 ± 9 years
Moderate-to-large MIMinnesota 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 IRAAt the end point (180 days) of observation
Minnesota Score 16 ± 3 ( compared with day 30)
NT-proBNP 566 ± 847 ()
180 daysNo 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 diameter6 patients
Dilated cardiomyopathyLVEF 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 surgeryLVEF 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 monthsNo 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.