Evaluation of tissue-engineered human acellular vessels as a Blalock–Taussig–Thomas shunt in a juvenile primate model

• DOI: 10.1016/j.xjon.2023.05.018
• Publication Date: 2023-08-09T02:37:22Z
• Authors: Kevin M. Nash; Brian A. Boe; Sergio A. Carrillo; Andrew Harrison; Ryuma Iwaki; John Kelly; Robert D. Kirkton; Ramkumar Krishnam...; Jeffrey H. Lawson; Yuichi Matsuzaki; Heather L. Prichard; Kejal Shah; Toshiharu Shinoka; Christopher K. Br...
• Keywords: Decellularization

Palliative treatment of cyanotic congenital heart disease (CCHD) uses systemic-to-pulmonary conduits, often a modified Blalock-Taussig-Thomas shunt (mBTTs). Expanded polytetrafluoroethylene (ePTFE) mBTTs have associated risks for thrombosis and infection. The Human Acellular Vessel (HAV) (Humacyte, Inc) is decellularized tissue-engineered blood vessel currently in clinical trials adults vascular trauma, peripheral artery disease, end-stage renal requiring hemodialysis. In addition to restoring flow, the engineered HAV demonstrates capacity host cellular remodeling into native-like vasculature. Here we report preclinical evaluation small-diameter (3.5 mm) as non-human primate model.We implanted 3.5 mm HAVs right subclavian pulmonary non-immunosuppressed juvenile rhesus macaques (n = 5). patency, structure, flow were assessed by postoperative imaging from 1 week 6 months. Histology surrounding tissues was performed.Surgical procedures well tolerated, with satisfactory anastomoses, showing feasibility using mBTTs. All had some immunological reactivity human extracellular matrix, expected this xenogeneic model. remained patent up months animals, exhibiting mild immunoreactivity. Two displaying more severe immunoreactivity material developed midgraft dilatation without bleeding or rupture. repopulation cells expressing smooth muscle endothelial markers observed all animals.These findings may support use CCHD potentially other pediatric indications.