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. 2022 Mar 27;11(12):2200045. doi: 10.1002/adhm.202200045

Table 1.

Summary of TEVG studies that involved clinical trials and large animal models

Graft scaffold materials Scaffold fabrication technique Graft inner diameter [mm] Cell sources Development status Major results Research lab or company References
PGA/PLCL Weft‐knitted PGA sealed by PCLC foam – Autologous bone marrow‐derived mononuclear cells (BM‐MNCs) Clinical trial (extracardiac‐modified Fontan conduit connecting the IVC to the pulmonary artery in children with single‐ventricle cardiac anomalies) Japan trial:

  • No acute graft failures or graft‐related deaths

  • Critical stenosis observed in 1 out of 25 patients 3 years after implantation

  • US trial (halted):

  • 3 out of 4 patients developed critical graft stenosis within the first 6 months

  • Early stenosis was treated with angioplasty

  • No additional graft‐related complications

 Breuer Lab Shin'oka et al., 2005; Hibino et al., 2010; Drews et al., 2020
Fibroblast‐deposited ECM Cell‐assembly extracellular matrix (CAM) 4.8 Autologous human fibroblast Clinical trial (arteriovenous access)

Function as hemodialysis access for up to 20 months in 5 patients

Primary patency was 78% after 1 month postimplantation and 60% after 6 months post implantation.

 L'Heureux N Lab McAllister et al., 2009
Human SMC‐deposited ECM Cell deposition and decellularization 6 Decellularized Phase 2 Clinical trial as arteriovenous access and ongoing Phase 3 trial Niklason Lab/Humacyte Kirkto et al., 2019
Human cadaveric SMC‐deposited ECM Cell deposition and decellularization 6 Decellularized

In vivo

(baboon model, arteriovenous access)

  • Patent for up to 6 months

  • Patency rate was 88%

  • No dilation and change in thickness for 24 weeks

  • No sign of infection, calcification, aneurysmal dilation, and no substantial intimal hyperplasia

 Niklason Lab/Humacyte Dahl et al., 2011
Allogeneic canine SMC‐deposited ECM Cell deposition and decellularization 3–4 Autologous ECs In vivo (canine carotid artery bypass graft)

  • Patency rate was 83%

  • No sign of infection, calcification, aneurysmal dilation, and no intimal hyperplasia at anastomoses up to 1 year

 Niklason Lab/Humacyte Dahl et al., 2011
Porcine SIS Decellularized and shaped into a tube – Acellular

In vivo (canine

model)

  • Patent for up to 60 days in the carotid artery.

  • Explant vessels showed increased strength due to remodeling. Burst pressures exceeded human vessels (*5600 mmHg).

 Lantz Sandusky et al., 1995; Roeder et al., 2000