Novel product and prototype development for soft tissue regeneration
Gingival recession affects ~50% of the population and results in the exposure of tooth root surfaces, which leads to an increased risk of dental caries. The gold standard treatment is autologous grafts involving tissue being harvested from the roof of a patient’s mouth, leading to pain and bleeding, the inability to eat, risk of infection, and the tissue that can be harvested can be insufficient, leading to the need for follow-up procedures. Materials on the market have inconsistent clinical outcomes, likely due to the lack of cells. As a result, autologous grafts remain the gold standard, leaving patients and clinicians in search of alternatives. In the proposed study, we will evaluate a tissue-engineered solution as a potential alternative, using a novel biomaterial and stem cells derived from fat tissue. The material will be characterized and subsequently seeded with adipose-derived cells. The resulting capillary/vessel networks will be characterized in vitro. To enable an intra-operative procedure the material will be functionalized, binding the relevant cell types from processed fat. Lastly, the functionalized material with captured fat-derived stem cells will be evaluated in a clinically relevant animal model and compared to the current clinical material standard. With an estimated 5.7M annual gingival graft surgeries in the US alone, this project will take a significant step towards helping the partner organization address clinical and patient demand, by moving closer to commercially viable manufacturing, material safety, and proof-of-concept in a clinically relevant gingival animal model.
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