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Limbal Stem Cell Deficiency (LSCD)
Clinical Trial Phase I/IIa

Background Information

Limbal stem cells (LSCs) are crucial for the regular physiological regeneration of the transparent anterior part of human eye, i.e. the corneal epithelium. Damage to the limbus, the area which forms the border between cornea and sclera, may cause a lack of LSCs leading to limbal stem cell deficiency (LSCD). Typical symptoms of LSCD involve corneal conjunctivalization, neovascularization and scarring as well as chronic ocular inflammation. This contribute to a loss of corneal transparency and may finally lead to profound vision impairment or even blindness. Conventional treatment options for corneal disorders like LSCD include transplantation of limbal auto- or allografts. However, limbal donor tissue is limited and transplantation is associated with a high risk of rejection.

Clinical success of transplantation has been described to be associated with the percentage of stem cells, characterized by expression of p63. Being a transcription factor, purification for p63 is unfortunately not feasible due to its intracellular location, but co-expression with the membrane-bound ABC transporter ABCB5 has been recently found allowing for monoclonal antibody-based LSC sorting. Besides its advantage in terms of purification, a central role of ABCB5 in corneal development and repair has been shown so far by various authors (Ksander et al., 2014; Gonzalez et al., 2017; Li et al., 2017). This suggests that the natural stem cell pool could potentially be restored by topical administration of ABCB5+ LSCs to the eye affected with LSCD, leading to regeneration of the corneal tissue to improve or restore vision


TICEBA has established a GMP-compliant manufacturing process to obtain, expand and isolate ABCB5+ LSCs from donor corneal tissue. The manufacturing process has been authorized in accordance with §13 of the German Medicinal Products Act (AMG). Safety and therapeutic efficacy of ABCB5+ LSCs has been shown in preclinical models.


Process

HERE you can find more information about the clinical trial with allogeneic ABCB5+ LSCs.


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