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Allogeneic human amnion epithelial cells (hAEC) are a cell-based biologic therapy derived from the epithelial layer of the human placental amnion. These cells are non-mesenchymal stromal cells that exhibit significant immunomodulatory and regenerative properties, making them a candidate for treating inflammatory and tissue-damage-related conditions. The therapy is currently being developed by Monash Health, in collaboration with Monash University and the Hudson Institute of Medical Research, specifically for the treatment of refractory perianal fistulising Crohn's disease. In this application, the cells are administered via local intralesional injection directly into the fistula tracts following surgical closure of the internal opening. A Phase I pilot study has demonstrated that the treatment is safe and feasible, with early signs of clinical efficacy in achieving fistula response in patients with refractory disease.
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