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Observational Study
. 2025 Feb 1;160(2):181-189.
doi: 10.1001/jamasurg.2024.4893.

Bioengineered Human Arteries for the Repair of Vascular Injuries

Ernest E Moore  1 , Michael Curi  2 , Nicholas Namias  3 , Rishi Kundi  4 , Ying Wei Lum  5 , Charles J Fox  4 , Ravi R Rajani  6 , Todd E Rasmussen  7 , Oleksandr Sokolov  8 , Laura E Niklason  9 , Zakaria Khondker  9 , Shamik J Parikh  9 ; CLN-PRO-V005 Investigators and the CLN-PRO-V017 Investigators
Collaborators, Affiliations
Observational Study

Bioengineered Human Arteries for the Repair of Vascular Injuries

Ernest E Moore et al. JAMA Surg. .

Erratum in

Abstract

Importance: Vascular injuries require urgent repair to minimize loss of limb and life. Standard revascularization relies on autologous vein or synthetic grafts, but alternative options are needed when adequate vein is not feasible and when clinical conditions preclude safe use of synthetic materials.

Objective: To evaluate the performance of the acellular tissue engineered vessel (ATEV) in the repair of arterial injuries.

Design, setting, and participants: Two open-label, single-arm, nonrandomized clinical trials, including 1 prospective civilian study (CLN-PRO-V005 [V005]) and 1 retrospective observational study in a war zone (CLN-PRO-V017 [V017]), were conducted from September 2018 to January 2024 (follow-up ongoing) at 19 level 1 trauma centers in the US and Israel and 5 frontline hospitals in Ukraine. Patients had vascular injury, no autologous vein available for emergent revascularization, and risk factors for wound infection. Data were analyzed from September 2023 to January 2024.

Intervention: The ATEV is a bioengineered vascular conduit grown from human vascular cells, available off the shelf, and implantable without immunosuppression.

Main outcomes and measures: Primary patency at day 30 was the primary outcome. Secondary outcomes included limb salvage, graft infection, and patient survival. A systematic literature review identified synthetic graft benchmarks in the treatment of arterial trauma for the same end points.

Results: The V005 and V017 studies evaluated 69 and 17 patients, respectively, and included 51 in V005 and 16 in V017 with noniatrogenic arterial injuries of the extremities. The majority were male (V005, 38 [74.5%]; V017, 16 [100%]), the mean (SD) ages were similar (V005, 33.5 [13.6] years; V017, 34.2 [9.0] years), and the mean (SD) Injury Severity Scores were similar (V005, 20.8 [10.5]; V017, 20.1 [18.9]). Penetrating injuries dominated (V005, 29 patients [56.9%]; V017, 14 patients [87.5%]). At day 30 for the V005 and V017 trials, respectively, ATEV primary patency was 84.3% (95% CI, 72.0%-91.8%) and 93.8% (95% CI, 71.7%-98.9%); secondary patency was 90.2% (95% CI, 79.0%-95.7%) and 93.8% (95% CI, 71.7%-98.9%); amputation rate was 9.8% (95% CI, 4.3%-21.0%) and 0% (95% CI, 0.0%-19.4%); ATEV infection rate was 2.0% (95% CI, 0.4%-10.3%) and 0% (95% CI, 0.0%-19.4%); and death rate was 5.9% (95% CI, 2.0%-15.9%) and 0% (95% CI, 0.0%-19.4%) (no deaths attributed to the ATEV). Day 30 synthetic graft benchmarks were as follows: secondary patency, 78.9%; amputation, 24.3%; infection, 8.4%; and death, 3.4%.

Conclusions and relevance: Results of 2 single-arm trials in civilian and real-world military settings suggest that the ATEV provides benefits in terms of patency, limb salvage, and infection resistance. Comparing ATEV outcomes with synthetic graft benchmarks demonstrates improved outcomes in the treatment of acute vascular injuries of the extremities.

Trial registration: ClinicalTrials.gov Identifiers: NCT03005418, NCT05873959.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Moore reported receiving grants from Humacyte during the conduct of the study; and receiving grants from Haemonetics and holding a patent for tissue plasminogen activator–thrombelastography issued to the Ernest E. Moore Shock Trauma Center at Denver Health shared with the University of Colorado Denver outside the submitted work. Dr Curi reported receiving grants from Humacyte during the conduct of the study; and receiving personal fees from Humacyte and owning publicly traded stock in Humacyte outside the submitted work. Dr Kundi reported receiving personal fees for consulting from Abiomed Inc outside the submitted work. Dr Fox reported serving as a clinical advisor for Prytime Medical Inc and receiving royalties from Wolters Kluwer outside the submitted work. Dr Rajani reported receiving grants from Humacyte to his institution during the conduct of the study. Dr Rasmussen reported receiving grants from Humacyte to his institution and both serving on the clinical advisory board and having an ownership interest in Prytime Medical outside the submitted work. Dr Sokolov reported receiving humanitarian aid and research fees from Humacyte during the conduct of the study. Dr Niklason reported being founder, chief executive officer, and member of the board of Humacyte, receiving salary from Humacyte, and owning stock in Humacyte during the conduct of the study; and holding numerous issued and pending US and international patents on engineered blood vessels with royalties paid, including some licensed to Humacyte, outside the submitted work. Dr Khondker reported being an employee of Humacyte during the conduct of the study and outside the submitted work. Dr Parikh reported serving as the chief medical officer, receiving salary, and owning stock options from Humacyte during the conduct of the study and outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow Diagrams for the V005 and V017 Studies
Flow diagrams are shown for the V005 study (A) and the V017 study (B). ATEV indicates acellular tissue engineered vessel.
Figure 2.
Figure 2.. Six-Month Ultrasonographic Images Following Acellular Tissue Engineered Vessel Implantation Into the Axillary Artery
In a woman with history of a single gunshot wound to the left shoulder, the axillary artery had near-complete transection; 2.5 to 3 cm of injured artery was removed, and an acellular tissue engineered vessel was implanted as an interposition graft. Proximal (A), mid (B), and distal (C) ultrasonographic images were obtained at the 6-month follow-up visit. EDV indicates end-diastolic velocity; PSV, peak systolic velocity; RI, resistive index.
Figure 3.
Figure 3.. Long-Term Efficacy Outcomes for Patients With Vascular Extremity Injuries Who Received the Acellular Tissue Engineered Vessel (ATEV) in the V005 and V017 Studies
Product-limit survival curves showing outcomes of secondary patency, freedom from conduit infection, limb salvage, and patient survival from 0 to 36 months. Patients were censored for withdrawal, loss to follow-up, death or amputation not due to the ATEV, and data cutoff.
See this image and copyright information in PMC

Comment on

  • Bioengineering on the Front Lines.
    Tonnessen BH, Dardik A. Tonnessen BH, et al. JAMA Surg. 2025 Feb 1;160(2):189. doi: 10.1001/jamasurg.2024.5137. JAMA Surg. 2025. PMID: 39565609 No abstract available.

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Associated data