Six-year outcomes of a phase II study of human-tissue engineered blood vessels for peripheral arterial bypass

Gutowski, Piotr; Guziewicz, Malgorzata; Iłżecki, Marek; Kazimierczak, Arkadiusz; Lawson, Jeffrey H.; Prichard, Heather L.; Przywara, Stanisław; Samad, Rabih; Tente, William E.; Turek, Jakub; Witkiewicz, Wojcieh; Zapotoczny, Norbert; Zubilewicz, Tomasz; Niklason, Laura E.

doi:10.1016/j.jvssci.2022.11.001

Cited by 8 publications

(8 citation statements)

References 46 publications

(58 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…[ 36 ] After implantation into 60 patients with end‐stage renal disease and a mean follow‐up time of 16 months, HAV was found to provide safe and functional hemodialysis access. [ 36 ] Based on the 5 year outcomes, HAV is likely to provide durable hemodialysis access, [ 37,38 ] further confirming the potential of cell‐derived dECM in bioengineering.…”

Section: Decmmentioning

confidence: 89%

Emerging Strategies for Optimizing Cell‐Derived Decellularized Extracellular Matrix Scaffolds in Tissue Engineering

Chen,

Zhang,

2024

Adv Eng Mater

View full text Add to dashboard Cite

As an ideal biological scaffold, cell‐derived decellularized extracellular matrix (dECM) is attracting increasing attention and has been prepared and studied for tissue engineering. However, a few barriers prevent its extensive clinical usage, indicating that it requires further optimization. This review starts with a brief introduction to the benefits and limitations of dECM as a biomaterial. Then, it provides a novel perspective summarizing and describing methods for dECM optimization, delineating strategies to optimize regular cell‐derived dECM sheet preparation and additional biochemical or mechanophysical procedures to further modify the scaffold. These innovative approaches equip engineered biomaterials based on cell‐derived dECMs with key properties and functionalities, thus providing a great opportunity for their broader future therapeutic applications. Finally, several ideas and directions for future development are also prospected.This article is protected by copyright. All rights reserved.

show abstract

Section: Decmmentioning

confidence: 89%

Emerging Strategies for Optimizing Cell‐Derived Decellularized Extracellular Matrix Scaffolds in Tissue Engineering

Chen,

Zhang,

2024

Adv Eng Mater

View full text Add to dashboard Cite

show abstract

“…This leads to the placement of central venous catheters for HD sites, which are associated with increased rates of adverse events such as all-cause mortality, bacteremia, and vascular access thrombosis [ 13 ]. Furthermore, HAV remodeling postoperatively has shown microvessel remodeling with cells that mimic native blood vessel composition and demonstrate continued durability and patency with a low risk of infection [ 11 ]. The HAV conduit has proven to be advantageous in another two phase 2 single-arm trials which showed reduced post-cannulation bleeding, immune response, mechanical failure, and incidence of adverse events, mimicking our progress thus far [ 4 ].…”

Section: Discussionmentioning

confidence: 99%

“…Bioengineered in a bioreactor, HAV is an investigational, shelf-stable human tissue-engineered vascular conduit, which is decellularized to mitigate implant rejection [ 6 ]. HAV has been used in clinical trials as an HD vascular access conduit in ESRD and for vascular reconstruction in PAD and vascular trauma [ 3 , 4 , 6 , 10 , 11 ]. Most recently, HAV has been utilized for humanitarian vascular trauma repair in Ukraine, and enrollment was completed for a Phase II/III vascular trauma trial (V005) to further investigate the use of human acellular vessel (HAV) in vascular trauma repair [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

Expanded Utility of Human Acellular Vessel in Hemodialysis Access Surgery and Arterial Aneurysm Repair

Nickerson,

Thamba,

Rao

et al. 2023

Cureus

View full text Add to dashboard Cite

Vascular access is essential for hemodialysis (HD) in patients with end-stage renal disease (ESRD). When the standard of care arteriovenous fistula (AVF) is limited, secondary to aneurysmal degeneration, trauma, and thrombus, interposition grafting is a reasonable reconstruction approach. As these grafts and comorbidities place ESRD patients at sustained risk of complications, reconstructions with regenerative medicine biologic conduits hold promise in improving safety and efficacy. Here, a biocompatible human acellular vessel (HAV) is our conduit of interest. With United States Food and Drug Administration use authorization under the Expanded Access Program, we report three cases of complex vascular access surgery with four aneurysm repairs using HAV. Patient selection focused on meeting unmet needs for those without adequate care alternatives, including active access and endoprosthetic stent graft infections, right heart failure due to high-output AVF, and arterial and access outflow aneurysms. In this high-risk expanded access population, operative technical success and interval success for patients given their inherent comorbidities, offer potential expanded utility of HAV in HD access surgery and arterial aneurysm repair.

show abstract

“…However, purified proteins isolated from animal or cadavers do not have a physiological arrangement, thus are rapidly degraded when implanted in vivo [8][9][10]. ECM assembled by cells in vitro recreate a more physiological structure and, for this reason, can be the material of choice for tissue engineering that aims to produce a stable structure [11][12][13][14][15]. TEVGs based on ECM synthesized by cells in vitro have been proposed as promising alternatives to synthetic grafts, especially because this is a cell-friendly material that promotes in vivo remodeling and avoids infection [11,16,17].…”

Section: Introductionmentioning

confidence: 99%

Effects of weaving parameters on the properties of completely biological tissue-engineered vascular grafts

Roudier,

Hourques,

Da Silva

et al. 2023

Biofabrication

View full text Add to dashboard Cite

Tissue-Engineered Vascular Grafts (TEVGs) made of human textiles have been recently introduced and offer remarkable biocompatibility as well as tunable mechanical properties. The approach combines the use of Cell-Assembled extracellular Matrix (CAM) threads, produced by cultured cells in vitro, with weaving, a versatile assembly method that gives fine control over graft properties. Herein, we investigated how production parameters can modify the geometrical and mechanical properties of TEVGs to better match that of native blood vessels in order to provide long-term patency. Our goals were to decrease the mechanical strength and the luminal surface profile of our first generation of woven TEVGs, while maintaining low transmural permeability and good suture retention strength.Different TEVGs were produced by varying CAM sheet strength as well as weaving parameters such as warp count, weft ribbons width, and weft tension. An optimized design reduced the burst pressure by 35%, wall thickness by 38% and increased compliance by 269%. The improved TEVG had properties closer to that of native blood vessels, with a burst pressure of 3492 mmHg, a wall thickness of 0.69 mm, and a compliance of 4.8%/100 mmHg, while keeping excellent suture retention strength (4.7 N) and low transmural permeability (24 mL·min-1·cm-2). Moreover, the new design reduced the luminal surface profile by 48% and utilized 47% less CAM. With a comparable design, the use of decellularized CAM threads, instead of devitalized ones, led to TEVGs with much more permeable walls and higher burst pressure.The next step is to implant this optimized graft in an allogeneic sheep model of arteriovenous shunt to assess its in vivo remodeling and performance.

show abstract

Six-year outcomes of a phase II study of human-tissue engineered blood vessels for peripheral arterial bypass

Cited by 8 publications

References 46 publications

Emerging Strategies for Optimizing Cell‐Derived Decellularized Extracellular Matrix Scaffolds in Tissue Engineering

Emerging Strategies for Optimizing Cell‐Derived Decellularized Extracellular Matrix Scaffolds in Tissue Engineering

Expanded Utility of Human Acellular Vessel in Hemodialysis Access Surgery and Arterial Aneurysm Repair

Effects of weaving parameters on the properties of completely biological tissue-engineered vascular grafts

Contact Info

Product

Resources

About