Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces

Ocular surface diseases and injury caused by chemicals, result in chronic ulceration, and may
never be able to be healed normally, and may lead to permanent vision loss. Standard medical
treatments often fail. Histologically and somehow functionally, human amniotic cells are
similar to ocular surface cells, and these cells have been shown to be safe to be
transplanted to another subject and will not be rejected by the recipient. In animal studies,
amniotic cells demonstrated that they can re-establish the integrity of ocular surface in
more than 30% of recipients without apparent toxic side effects. This study will investigate
this novel strategy for its effect on human ocular surface disorder. It will provide a
potential alternative therapy for this difficult and devastating disease.

Inclusion Criteria:

- Patients with corneal epithelial defects and ulcers that have persisted for 4 weeks or
longer, regardless of their cause. These patients will have received traditional
medical therapy, including correcting the underlying causes, suppressing inflammation,
and augmenting the tissue healing processes, but the epithelial defects have
persisted.

Exclusion Criteria:

- Patients who are pregnant or under age 18 will be excluded.

- Placentas will not be used if the following problems are present:

- If the mother has an infection at the time of her baby's birth;

- If the mother has a high risk of developing infection due to intravenous drug use
or other factors;

- If the mother has diabetes, arthritis, or raised blood pressure;

- If the baby is unhealthy;

- If there is evidence of infection of the womb (uterus) and afterbirth (placenta)
at the time of delivery.