Five Year Outcomes in Patients with End Stage Renal Disease Who Received a Bioengineered Human Acellular Vessel for Dialysis Access

Jakimowicz, Tomasz; Przywara, Stanisław; Turek, Jakub; Pilgrim, Alison; Zapotoczny, Norbert; Zubilewicz, Tomasz; Lawson, Jeffrey H.; Niklason, Laura E.

doi:10.1016/j.ejvsvf.2022.01.003

Cited by 19 publications

(21 citation statements)

References 21 publications

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“…To our end, ISO conform biocompatibility tests performed with human plasma on xenogeneic serum‐free hTEMs did perform similarly to control hTEMs, thereby reducing the risks of a major inflammatory response once in vivo as reported elsewhere. [ 56 ]…”

Section: Discussionmentioning

confidence: 99%

Xenogeneic Serum‐Free Human Cell‐Derived Tissue Engineered Matrices for the Development of Clinical‐Grade Biomimetic Cardiovascular Devices

Zaytseva

Visser

Ehterami

et al. 2023

Advanced Therapeutics

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The development of next‐generation biomimetic cardiovascular implants using tissue engineering concepts can address the existing shortcomings of the clinically available prostheses, offering the possibility to generate life‐long, native‐analogous constructs with self‐remodeling and regenerative capacities. Scaffolds for tissue‐engineered cardiovascular prostheses can be obtained from allogenic cell sources, that can then produce human tissue‐engineered matrices (hTEMs) in vitro. Traditionally, fetal bovine serum (FBS) is used as a universal cell growth supplement. However, concerns regarding its biosafety remain a challenge for clinical translation. The aim of this study is to develop a novel xenogeneic serum‐free approach for the manufacturing of clinical grade hTEMs. To achieve this, decellularized hTEMs are generated under xenogeneic serum‐free conditions and have subsequently demonstrated hTEMs perform similarly to the FBS‐supplemented control group in terms of extracellular matrix (ECM) composition, hemocompatibility, thrombogenicity, and calcification potential. Finally, the xenogeneic serum‐free protocol is successfully adapted to the development of hTEM‐based tissue‐engineered heart valves for the systemic circulation, showing proof‐of‐concept functionality in vitro. Overall, the data suggest the effectiveness of xenogeneic serum‐free culture method as a valid alternative to FBS for the production of hTEM for cardiovascular applications.

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Section: Discussionmentioning

confidence: 99%

Xenogeneic Serum‐Free Human Cell‐Derived Tissue Engineered Matrices for the Development of Clinical‐Grade Biomimetic Cardiovascular Devices

Zaytseva

Visser

Ehterami

et al. 2023

Advanced Therapeutics

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“…PGA has been widely used in the vascular tissue engineering because of its good biocompatibility and degradation. Two phase 2 single‐arm trials have shown that bioengineered vascular grafts achieved by using biodegradable PGA polymer scaffolds may provide durable and functional hemodialysis access for patients with end‐stage renal disease (Jakimowicz et al., 2022; Lawson et al., 2016). Evaluating the synthetic potential of normoxia‐ and hypoxia‐preconditioned hiPSC‐VSMCs at the tissue level, is important to vascular tissue engineering.…”

Section: Discussionmentioning

confidence: 99%

Hypoxia facilitates proliferation of smooth muscle cells derived from pluripotent stem cells for vascular tissue engineering

Fang

Mei

Yao

et al. 2022

J Tissue Eng Regen Med

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Tissue-engineered blood vessels (TEBVs) show significant therapeutic potential for replacing diseased blood vessels. Vascular smooth muscle cells (VSMCs) derived from human induced pluripotent stem cells (hiPSCs) via embryoid body (EB)-based differentiation, are promising seed cells to construct TEBVs. However, obtaining sufficient high-quality hiPSC-VSMCs remains challenging. Stem cells are located in a niche characterized by hypoxia. Hence, we explored molecular and cellular functions at different induction stages from the EB formation commencement to the end of directed differentiation under normoxic and hypoxic conditions, respectively. Hypoxia enhanced the formation, adhesion and amplification rates of EBs. During directed differentiation, hiPSC-VSMCs exhibited increased cell viability under hypoxic conditions. Moreover, seeding hypoxia-pretreated cells on biodegradable scaffolds, facilitated collagen I and elastin secretion, which has significant application value for TEBV development. Hence, we proposed that hypoxic treatment during differentiation effectively induces proliferative hiPSC-VSMCs, expanding high-quality seed cell sources for TEBV construction.

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“…From this trial, 16 tissue samples were acquired from 16 to 200 weeks for the characterization of vascular remodeling, showing recellularization of grafts by non-inflammatory host progenitor and vascular cells (Kirkton et al, 2019). A recent follow-up report provided 5-year (phase II) results on 11 patients who completed the study Frontiers in Bioengineering and Biotechnology frontiersin.org (Jakimowicz et al, 2022). Results showed that one patient maintained primary patency, and 10 maintained secondary patency.…”

Section: Clinical Trials and Potential Commercialization Valuesmentioning

confidence: 99%

Strategies to counteract adverse remodeling of vascular graft: A 3D view of current graft innovations

Tan

Boodagh

Parthiban

et al. 2023

Front. Bioeng. Biotechnol.

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Vascular grafts are widely used for vascular surgeries, to bypass a diseased artery or function as a vascular access for hemodialysis. Bioengineered or tissue-engineered vascular grafts have long been envisioned to take the place of bioinert synthetic grafts and even vein grafts under certain clinical circumstances. However, host responses to a graft device induce adverse remodeling, to varied degrees depending on the graft property and host’s developmental and health conditions. This in turn leads to invention or failure. Herein, we have mapped out the relationship between the design constraints and outcomes for vascular grafts, by analyzing impairment factors involved in the adverse graft remodeling. Strategies to tackle these impairment factors and counteract adverse healing are then summarized by outlining the research landscape of graft innovations in three dimensions—cell technology, scaffold technology and graft translation. Such a comprehensive view of cell and scaffold technological innovations in the translational context may benefit the future advancements in vascular grafts. From this perspective, we conclude the review with recommendations for future design endeavors.

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Five Year Outcomes in Patients with End Stage Renal Disease Who Received a Bioengineered Human Acellular Vessel for Dialysis Access

Cited by 19 publications

References 21 publications

Xenogeneic Serum‐Free Human Cell‐Derived Tissue Engineered Matrices for the Development of Clinical‐Grade Biomimetic Cardiovascular Devices

Xenogeneic Serum‐Free Human Cell‐Derived Tissue Engineered Matrices for the Development of Clinical‐Grade Biomimetic Cardiovascular Devices

Hypoxia facilitates proliferation of smooth muscle cells derived from pluripotent stem cells for vascular tissue engineering

Strategies to counteract adverse remodeling of vascular graft: A 3D view of current graft innovations

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