Table 2.
Summary of clinical trials quantitative data using various scaffold in cardiac tissue engineering.
| Study name | Scaffold | Objective | Patients | Diagnosis | Pretreatment heart function | Surgical procedure | Posttreatment heart function | Follow-up time | Adverse impacts |
|---|---|---|---|---|---|---|---|---|---|
| CorMatrix ECM trial | CorMatrix (decellularized porcine small intestinal submucosa) | To evaluate the safety of CorMatrix for intraventricular repair of mechanical complications of MI | 11 consecutive patients Between July 2011 and October 2012 Age 67 ± 11 years |
LV aneurysm, Ischemic VSD, MI | LVEF 31 ± 7% | All the patients underwent patch repair using CorMatrix ECM with a running Prolene suture technique | The data of LVEF not provided; No evidence of ventricular thrombus, and there were no thromboembolic events |
207 ± 211 days | No complications of CorMatrix ECM repair failure including readmission for any cardiac cause or death |
|
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| MAGNUM | Collagen matrix | To evaluate intrainfarct cell therapy associated with a cell-seeded collagen scaffold grafted onto infarcted ventricles | 15 consecutive patients Aged 54.2 ± 3.8 years |
MI with surgical indication for CABG and LV wall has postischemic scars | NHYA 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 area | NHYA FC 1.4 ± 0.3 (p = 0.005) LVEF 33 ± 5% (p = 0.04) LVEDVol 117 ± 21 ml (p = 0.03) LVFDT 196 ± 8 (p = 0.01) Blind Radioisotopic/MRI showed that 58 ± 9.3% of the cell-implanted segments improved their kinetics and viability |
3 months | Not reported |
|
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| ESCORT (NCT02057900) |
Fibrin patch matrix | To assess the feasibility and safety of a transplantation of cardiac-committed progenitor cells | Patients recruiting (estimated enrollment 6 patients) | Ischemic heart disease | NHYA FC and LVEF | 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 |
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| 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 (p < 0.05 compared with day 30) NT-proBNP 566 ± 847 (p < 0.05) |
180 days | No significant ventricular arrhythmia was observed; None of adverse events were judged to be related to the device |
|
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| 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 (p < 0.05) 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.