Table 2.

Clinical applications of tissue-engineered technologies.

Trial or graft (year)	Prosthesis	Procedure	Mean age (years)	Main findings	Ref.
Decellularized homograft-based valve replacements
ARISE (2020, NCT02527629)	Decellularized aortic homograft	SAVR	33.6 ± 20.8	Decellularized aortic homografts are safe for aortic valve replacement with excellent hemodynamics in the short follow-up period.	37,39
ESPOIR (2022, NCT02035540)	Decellularized pulmonary homograft	SPVR	Range 2-38	5-year data show excellent performance for decellularized pulmonary homografts with low rates of adverse events.	40
Decellularized xenograft-based valve replacements
Porcine SIS (2020, NCT02397668)	Tricuspid valve	Surgical tricuspid replacement	NA	Good valve performance, mild regurgitation.	34
Porcine decellularized pulmonary valve (2019)	Decellularized pulmonary valve	SPVR	57 ± 11	Valvular dysfunction and ventricular failure.	34
Decellularized hTEM-based vascular grafts
Humacyte (2022, NCT01744418)	Bioengineered human acellular vessel	Hemodialysis	18-80	Phase II long-term follow-up study shows that the human acellular vessel provides durable and functional hemodialysis access for patients with end stage renal disease.	41
Bioresorbable polymer-based vascular grafts and valve replacement
Tissue-engineered vascular graft (2020, IDE14127)	Pre-seeded biodegradable conduit	Fontan conduit	N.A.	Promising function and potential for growth, remodeling, and repair. Longer follow-up studies are necessary.	42
Xeltis vascular graft (2017, NCT02377674)	Biodegradable conduit, COR-VG-001	Fontan conduit	4-12	No device-related adverse events were reported. Anatomical and functional stability in all patients at 12 months.	43
Xplore-1 (2020, NCT02700100)	Biodegradable polymeric valve	SPVR	2-12	No major clinical events and no signs of aneurysm or stenosis at 2 years follow-up. Moderate or severe regurgitation detected.	34
Xplore-2 (2020, NCT03022708)	Biodegradable polymeric valve	SPVR	2-9	Valve stenosis was reported at 1-year follow-up.	34