Humacyte Announces Publication of Biological Mechanism Explaining Low Rates of Infection Observed in Clinical Study of Human Acellular Vessel (HAV)

Results published in Journal of Vascular Surgery – Vascular Science

DURHAM, N.C., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announces the publication of controlled in vitro studies in the Journal of Vascular Surgery – Vascular Science describing the scientific basis for the significantly lower rates of infection observed in a clinical trial of the investigational HAV compared to synthetic expanded polytetrafluoroethylene (ePTFE) grafts. The in vitro study results show the HAV had more host cell infiltration than ePTFE grafts, and that the biocompatibility of the HAV supported neutrophil viability and function, each of which may explain the HAV’s superior resistance to bacterial infection versus ePTFE grafts observed in the clinical trial. 

The publication, titled Biological Mechanisms of Infection Resistance in Tissue Engineered Blood Vessels Compared to Synthetic ePTFE Grafts, combined histological evaluation of the HAV and ePTFE explants from both preclinical and clinical studies as well as in vitro experiments assessing the viability and function of human neutrophils on these materials. Neutrophils are a critical cell type for host defense against infection. Data analyzed from a comparative clinical trial demonstrated that the HAV had a significantly lower infection rate than ePTFE grafts. A biological rationale for this finding was then shown through explant histopathology and cell experiments which demonstrated that the HAV, but not ePTFE grafts, supported neutrophil viability and function. These results continue to build upon the functional benefits of HAV biocompatibility which has been previously observed to permit adaptive host vascular remodeling and now host immune activity for infection resistance.

“This study further supports that the HAV has the potential to serve as a breakthrough treatment to save the lives and limbs of patients suffering from a wide range of medical conditions, from trauma to peripheral artery disease,” said Dr. Laura Niklason, CEO of Humacyte. “Our goal is to provide a solution that overcomes the current limitations in existing standards of care, in this case remembering that vascular graft infection can be a devastating and costly outcome for patients already suffering from severe and complex conditions.”