Trial reportLancet (London, England)2016
Bioengineered human acellular vessels for dialysis access in patients with end-stage renal disease: two phase 2 single-arm trials.
Trial report in Lancet (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 162 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Pilot Study for Evaluation of the Safety and Efficacy of Humacyte's Human Acellular Vascular Graft for Use as a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease
A Phase I Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vascular Graft for Use as a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease
Who cites it
162 citing papers in PubMed, 1 synthesis or guideline pooled it, 358 citations in OpenAlex.
- Concise Review: Patency of Small-Diameter Tissue-Engineered Vascular Grafts: A Meta-Analysis of Preclinical Trials.Stem cells translational medicine · 2019Pooled it
- Induced Pluripotent Stem Cell-Derived Small-Diameter Vascular Grafts: Scaffold Design, Immune Engineering, and Clinical Translation.Journal of cellular physiology · 2026Review
- 18 Month patency of acellular bioengineered regenerative conduit as coronary artery bypass.Nature communications · 2026Article
- Small Diameter Vascular Grafts Made in Minutes.Advanced materials (Deerfield Beach, Fla.) · 2026Article
- Evolutions in Cardiovascular Implants-A Review of Past, Present, and Future.Micromachines · 2026Review
- Phosphatidylserine-everted erythrocyte membrane vesicles enhance efferocytosis and remodeling of vascular grafts.Nature communications · 2026Article
- First European Clinical Implant of an Off-the-Shelf Bioengineered Blood Vessel for Coronary Artery Bypass.Journal of clinical medicine · 2026Article
- Reinforced biotubes as readily available and regenerative vascular grafts.Nature communications · 2026Article
- Vascular Access 4.0 for Hemodialysis: Toward a Needle-Free, Smart, Closed, and Connected System.Journal of clinical medicine · 2026Article
- Biofunctionalized Vascular Access Graft Improves Patency and Endothelialization in a Porcine Arteriovenous Model.Journal of functional biomaterials · 2026Article
- Barriers to clinical translation of small-diameter tissue-engineered vascular grafts in peripheral reconstruction.JVS-vascular science · 2026Review
- Fabrication and characterization of small-caliber nanofibrous vascular scaffolds with sustained release of endothelial cell derivatives and heparin.Frontiers in bioengineering and biotechnology · 2026Article
- Decellularized vascular matrix material-based TEVG coated with PRP for anti-degradation and anti-inflammation.International journal of surgery (London, England) · 2026Article
- Acellular Tissue Engineered Vessels as Coronary Artery Bypass Grafts.JACC. Basic to translational science · 2025Article
- Artificial blood vessels-clinical development of TEVG.Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs · 2025Review
- Future Frontiers in Bioinspired Implanted Biomaterials.Advanced materials (Deerfield Beach, Fla.) · 2025Review
- Review
- Towards Safety and Regulation Criteria for Clinical Applications of Decellularized Organ-Derived Matrices.Bioengineering (Basel, Switzerland) · 2025Review
- Targeting Smad3 Phosphorylation Attenuates Anastomotic Intimal Hyperplasia and Perigraft Fibrosis in Decellularized Tissue-Engineered Vascular Grafts.Biomaterials research · 2025Article
- Developing scalable woven textile-based scaffolds for tubular tissues with Core-Sheath nanofibre yarns and tuneable weave architectures.Frontiers in bioengineering and biotechnology · 2025Article
102 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
16 authors at 7 institutions in 2 countries.
Funding
Abstract
backgroundFor patients with end-stage renal disease who are not candidates for fistula, dialysis access grafts are the best option for chronic haemodialysis. However, polytetrafluoroethylene arteriovenous grafts are prone to thrombosis, infection, and intimal hyperplasia at the venous anastomosis. We developed and tested a bioengineered human acellular vessel as a potential solution to these limitations in dialysis access.
methodsWe did two single-arm phase 2 trials at six centres in the USA and Poland. We enrolled adults with end-stage renal disease. A novel bioengineered human acellular vessel was implanted into the arms of patients for haemodialysis access. Primary endpoints were safety (freedom from immune response or infection, aneurysm, or mechanical failure, and incidence of adverse events), and efficacy as assessed by primary, primary assisted, and secondary patencies at 6 months. All patients were followed up for at least 1 year, or had a censoring event. These trials are registered with ClinicalTrials.gov, NCT01744418 and NCT01840956.
findingsHuman acellular vessels were implanted into 60 patients. Mean follow-up was 16 months (SD 7·6). One vessel became infected during 82 patient-years of follow-up. The vessels had no dilatation and rarely had post-cannulation bleeding. At 6 months, 63% (95% CI 47-72) of patients had primary patency, 73% (57-81) had primary assisted patency, and 97% (85-98) had secondary patency, with most loss of primary patency because of thrombosis. At 12 months, 28% (17-40) had primary patency, 38% (26-51) had primary assisted patency, and 89% (74-93) had secondary patency.
interpretationBioengineered human acellular vessels seem to provide safe and functional haemodialysis access, and warrant further study in randomised controlled trials.
fundingHumacyte and US National Institutes of Health.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.