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Description
To introduce treatment for a blinding corneal disorder, limbal stem cell deficiency (LSCD), using advanced stem cell-based transplantation therapy into clinical practice. First, a xenogeneic-free protocol for limbal epithelial cell preparation will be ameliorated via cooperation with partners. After verification in preclinical practice and approval by the National Authority, a Clinical trial 1 using these cells will be conducted in ≥12 patients with unilateral LSCD. In parallel, we will prepare a xenogeneic-free cultivation protocol of autologous epithelial cells. Clinical trial 2 will be conducted on ≥12 patients with bilateral LSCD. Methods for cell preparation will be tested for safety (DNA stability), and the method for long-term preservation of cells will be developed (vitrification).
Summary of project results
The project aimed to address the issue of limbal stem cell deficiency (LSCD), a condition that can cause vision loss. The project sought to develop a new treatment for LSCD using cultured limbal epithelial cells.
This project focused on improving methods for growing cells from the eye and mouth. Researchers experimented with different ways to cultivate these cells, including growing them directly from tissue samples (explant culture) and testing various materials to support cell growth. They also assessed the health and genetic stability of the cells to ensure quality. The project successfully produced standardized techniques for culturing both eye and mouth cells. Additionally, they gathered valuable information on the genetic stability and overall quality of the cells grown using these methods.
The project developed a new treatment for LSCD and demonstrated the safety of the new treatment. The project prepared the way for a clinical trials of the new treatment for patients with LSCD.
Summary of bilateral results
The project would not have been successful without bilateral cooperation. Bilateral joint research and collaboration on joint results has strengthened the knowledge of all involved parties and strengthened the bilateral cooperation which can continue.