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Surgery

The Human Acellular Vessel for Vascular Reconstruction or BypassA Novel Biologic Conduit for Vascular Bypass and Repair

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JAMA Surgery

Published Online: June 22, 2022

Surgical Innovation

Article Information and Disclosures

Alexis L. Lauria, MD¹;

Indrani Sen, MBBS²;

Todd E. Rasmussen, MD²

Author Affiliations

¹Walter Reed National Military Medical Center and the Uniformed Services University Bethesda, Bethesda, Maryland
²Mayo Clinic, Rochester, Minnesota

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The Human Acellular Vessel (HAV) (Humacyte Inc) is a new biologic vascular conduit developed using regenerative medicine technology. Human vascular smooth muscle cells derived from US Food and Drug Administration (FDA)–registered tissue donors are isolated, expanded in culture, and seeded onto a biodegradable, polyglycolic acid mesh scaffold. The scaffolds are maintained within bioreactors and the developing vessels undergo pulsatile, cyclic distension for 8 weeks. The scaffold degrades and the newly formed extracellular matrix, including collagens type I and III, fibronectin, and vitronectin, is decellularized to remove immunogenic material while preserving the new vessel’s structure, tensile strength, and durability (Figure, A).¹^- 4

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Article Information

Corresponding Author: Todd E. Rasmussen, MD, Mayo Clinic, Department of Surgery, Rochester, MN 55905 (rasmussen.todd@mayo.edu).

Published Online: June 22, 2022. doi:10.1001/jamasurg.2022.1214

Conflict of Interest Disclosures: Dr Rasmussen reported personal fees from Humacyte for clinical consultation outside the submitted work. No other disclosures were reported.

References

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Lawson JH , Glickman MH , Ilzecki M , et al. Bioengineered human acellular vessels for dialysis access in patients with end-stage renal disease: two phase 2 single-arm trials. Lancet. 2016;387(10032):2026-2034. doi:10.1016/S0140-6736(16)00557-2 PubMed Google Scholar Crossref

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Poh M , Boyer M , Solan A , et al. Blood vessels engineered from human cells. Lancet. 2005;365(9477):2122-2124. doi:10.1016/S0140-6736(05)66735-9 PubMed Google Scholar Crossref

Gutowski P , Gage SM , Guziewicz M , et al. Arterial reconstruction with human bioengineered acellular blood vessels in patients with peripheral arterial disease. J Vasc Surg. 2020;72(4):1247-1258. doi:10.1016/j.jvs.2019.11.056 PubMed Google Scholar Crossref

Kirkton RD , Santiago-Maysonet M , Lawson JH , et al. Bioengineered human acellular vessels recellularize and evolve into living blood vessels after human implantation. Sci Transl Med. 2019;11(485):eaau6934. doi:10.1126/scitranslmed.aau6934 PubMed Google Scholar Crossref

Niklason LE , Abbott W , Gao J , et al. Morphologic and mechanical characteristics of engineered bovine arteries. J Vasc Surg. 2001;33(3):628-638. doi:10.1067/mva.2001.111747 PubMed Google Scholar Crossref

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 credit toward the CME [and Self-Assessment requirements] of the American Board of Surgery’s Continuous Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.