Minimally immunogenic decellularized porcine valve provides in situ recellularization as a stentless bioprosthetic valve

Currently used bioprosthetic valves have several limitations such as calcification and functional deterioration, and revitalization through cellular ingrowth is impossible. To overcome these obstacles, we have developed a minimally immunogenic tissue-engineered valve that consists of an unfixed, decellularized porcine valve scaffold capable of being spontaneously revitalized in vivo after implantation. Porcine aortic root tissue was decellularized using detergents such as sodium lauryl sulfate and Triton X-100. The porcine valve was treated very gently and plenty of time was allowed for constituents to diffuse in and out of the matrix. In a preliminary study, a piece of decellularized porcine valve tissue was implanted into the rat subdermal space for 14 and 60 days and the structural integrity and calcification were evaluated. As an in vivo valve replacement model, the decellularized porcine valve was implanted in the pulmonary valve position in dogs and functional and histological evaluation was performed after 1, 2, and 6 months. Histological examination showed that the newly developed detergent treatment effectively removed cellular debris from the porcine aortic tissue. Decellularized porcine valve tissue implanted subdermally in rats showed minimal inflammatory cell infiltration and calcification. In the valve replacement model, spontaneous reen-dothelialization and repopulation of the medial cells were observed within 2 months, and good valve function without regurgitation was observed by echocardiography up to 6 months. The minimally immunogenic decellularized porcine valve proved effective in mitigating postimplant calcification and provided a suitable matrix for revitalizing prostheses through in situ recellularization, cellular ingrowth, and tissue remodeling.