| Abstract: | Purpose To highlight the design process for tissue engineered mucosa and evaluate the results of an in – vivo immunologic survey done in an animal model. Methods 21 Sprague Dawley rats were divided into three groups to study the systemic immune response to our developed biomaterial, with two other materials used for comparison. Serial subcutaneous implantation was done to serve as antigenic booster .The animals were sacrificed after a 31 day period and their spleens were harvested, digested to make single cell suspensions and used flow cytometry to quantitate CD4+ and CD8+ cells. The CD8+ cells counts are a reflection of the immuno‐toxicity of the material. Results CD 4+ and CD8+ counts were expressed as a percentage of total cells. The mean and standard deviation of CD8+ counts of our potential scaffold material was 19.782 ± 4.021 as compared to Duragen which was 21.574 ± 3.837 and the group with porcine skin 19.598 ± 3.678. Conclusions Striving towards the goal of creating a bioengineered mucosa requires an optimal scaffold with proven immunologic safety. We have attempted to study the systemic immunologic response by comparing our biomaterial with existing materials that are already in clinical use. Though absolute values of CD8+ are comparable and within the same range, larger trials will be needed to establish significant benefits of one over the other. |
