The mechanism of action of limbal stem cells implantation is the replacement of corneal epithelium and lost limbal stem cells in patients in which the limbus has been destroyed by ocular burns. During the corneal repair process, the administered stem cells are intended to partially multiply, differentiate and migrate to regenerate corneal epithelium, as well as maintaining a reservoir of stem cells that can continually regenerate the corneal epithelium.
Conventional pharmacodynamic studies have not been performed.
The product is implanted locally.
The nature and intended clinical use of limbal stem cells implantation are such that conventional pharmacokinetic studies on absorption, biotransformation and elimination are not applicable. Immunohistochemical analysis of cornea taken from patients receiving keratoplasty after limbal stem cells implantation treatment demonstrated that the transplanted stem cells establish a normal layer of stratified corneal epithelium, which do not migrate or invade basal ocular structures.
Non-clinical safety data were limited to in vitro testing of tumorigenicity of the human autologous cell cultures. These tests included cell karyotype, cell growth in soft agar and growth factor-dependent proliferation. In vitro studies have revealed no evidence of anchorage-independent growth indicative of tumorigenic potential.
The safety of limbal stem cells is demonstrated in the results obtained from the two retrospective clinical studies.
Conventional non-clinical reproductive and developmental toxicity studies are not considered relevant, given the nature and the intended clinical use of the autologous product.
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